gpt4_simulated_data.json

[
    {
        "input": " A Phase II, Open-Label Study Evaluating the Efficacy and Safety of AZD9291 in Advanced NSCLC Patients with EGFR T790M Mutation Post Platinum-Based Chemotherapy and EGFR-TKI Therapy**\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) with stage IIIB/IV disease or recurrent disease.\n2. Documented evidence of EGFR T790M mutation identified through a plasma sample or tissue biopsy.\n3. Progression of disease after treatment with an approved or investigational EGFR-TKI and after platinum-based chemotherapy.\n4. At least one measurable lesion as defined by RECIST 1.1.\n5. ECOG performance status of 0-2.\n6. Adequate organ and marrow function as defined by protocol-specific laboratory criteria.\n7. Age \u2265 18 years.\n8. Ability to swallow and retain oral medication.\n9. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria:\n1. Patients with known mutations in EGFR other than T790M as the resistance mechanism to prior EGFR-TKI therapy.\n2. Prior treatment with AZD9291 or other investigational drugs targeting EGFR T790M mutation.\n3. Presence of symptomatic central nervous system metastases or metastases that require local therapy such as radiation or surgery.\n4. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.\n5. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.\n6. History of another primary malignancy within the last 3 years, except for malignancies with a negligible risk of metastasis or death.\n7. Participation in another clinical study with an investigational product during the last 30 days before enrollment.\n8. Known hypersensitivity to AZD9291 or any excipient of the product.\n\n**",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR mutation\"]]}"
    },
    {
        "input": " A Randomized Phase III Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib versus Chemotherapy in Participants with Advanced Endometrial Cancer with Mismatch Repair Deficiency (dMMR) or High Microsatellite Instability (MSI-H)**\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of advanced (unresectable or metastatic) endometrial carcinoma.\n2. Documented evidence of dMMR or MSI-H status in tumor tissue from a primary or metastatic site.\n3. Progression on or after at least one prior systemic therapy in the advanced setting or be considered not suitable for treatment with curative intent.\n4. At least one measurable lesion as defined by RECIST 1.1.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ function as defined by protocol-specific laboratory criteria.\n7. Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.\n8. Age \u2265 18 years.\n9. Ability to swallow and retain oral medication.\n\nExclusion Criteria:\n1. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.\n2. Patients with known additional malignancy that is progressing or has required active treatment within the past 3 years.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years.\n4. Active brain metastases or leptomeningeal metastases.\n5. History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n6. Active infection requiring systemic therapy.\n7. Pregnant or breastfeeding women, or women expecting to conceive or father children within the projected duration of the trial.\n8. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n9. Prior treatment with Lenvatinib or any other VEGFR-targeted agent.\n10. Presence of any genetic syndromes associated with an increased risk of endometrial cancer.",
        "output": "{\"inclusion_biomarker\": [[\"Mismatch Repair Deficiency\"], [\"Microsatellite Instability High\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label Study Evaluating the Efficacy of AZD9291 (Osimertinib) in Combination with Bevacizumab in Patients with EGFR Mutation-Positive NSCLC with Progressive Disease After First-Line EGFR TKI Therapy\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) with evidence of stage IV disease.\n2. Documented evidence of an EGFR sensitizing mutation (exon 19 deletion or L858R mutation) in the tumor tissue or plasma.\n3. Progressive disease following first-line treatment with an FDA-approved EGFR TKI.\n4. Measurable disease according to RECIST v1.1 criteria.\n5. ECOG performance status of 0-1.\n6. Adequate bone marrow, liver, and renal function.\n7. Age \u2265 18 years.\n8. Ability to provide written informed consent.\n9. Women of childbearing potential must have a negative pregnancy test prior to the start of treatment and agree to use effective contraception during the study and for 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n1. Known T790M mutation (patients with T790M mutation are eligible for other targeted therapies).\n2. Prior treatment with AZD9291 (Osimertinib) or any other EGFR T790M-specific inhibitor.\n3. Previous treatment with Bevacizumab or other VEGF/VEGFR inhibitors.\n4. Active brain metastases or leptomeningeal disease. Patients with previously treated brain metastases that are asymptomatic and do not require steroids for at least 4 weeks before starting study treatment are eligible.\n5. History of interstitial lung disease or pneumonitis.\n6. Uncontrolled hypertension despite optimal medical management.\n7. Significant cardiovascular disease (e.g., New York Heart Association Class II or greater heart failure, myocardial infarction within the past 3 months, unstable angina, or poorly controlled arrhythmia).\n8. Major surgical procedure within 28 days prior to starting study drug or anticipation of the need for a major surgical procedure during the course of the study.\n9. Other malignancies within the last 5 years except for adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or localized prostate cancer with a current PSA of \u2264 1.0 mg/dL on a stable dose of luteinizing hormone-releasing hormone (LHRH) agonist or having undergone orchiectomy.\n10. Pregnant or breastfeeding women.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR exon 19 deletion\"], [\"EGFR L858R\"]], \"exclusion_biomarker\": [[\"EGFR T790M\"]]}"
    },
    {
        "input": " A Randomized Phase III Study to Evaluate the Efficacy of Pembrolizumab in Combination with Carboplatin and Paclitaxel in Patients with Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) with PD-L1 Expression and Without EGFR or ALK Genomic Tumor Aberrations\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of squamous NSCLC that is either locally advanced, not amenable to surgical resection or radiation therapy with curative intent, or metastatic.\n2. PD-L1 expression in tumor cells determined by an FDA-approved test.\n3. No EGFR or ALK genomic tumor aberrations.\n4. No prior systemic chemotherapy treatment for advanced or metastatic NSCLC.\n5. ECOG performance status of 0-1.\n6. Measurable disease according to RECIST v1.1 criteria.\n7. Adequate organ function.\n8. Age \u2265 18 years.\n9. Ability to provide written informed consent.\n10. Women of childbearing potential and men must agree to use adequate contraception from the time of signing the informed consent form through 120 days after the last dose of study medication.\n\nExclusion Criteria:\n1. Presence of EGFR sensitizing mutations or ALK genomic tumor aberrations.\n2. Active autoimmune disease that has required systemic treatment in the past 2 years.\n3. A history of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n4. Active brain metastases or leptomeningeal metastases. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.\n5. An active infection requiring systemic therapy.\n6. A history of another malignancy within 2 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix.\n7. Receipt of live, attenuated vaccine within 30 days prior to the first dose of trial treatment.\n8. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n9. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).",
        "output": "{\"inclusion_biomarker\": [[\"PD-L1 expression\"]], \"exclusion_biomarker\": [[\"EGFR mutation\"], [\"ALK mutation\"]]}"
    },
    {
        "input": " A Phase II, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of AZD9291 (Osimertinib) in T790M Mutation-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Failed First-Line EGFR-TKI Therapy.\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of NSCLC that is locally advanced or metastatic.\n2. Documented evidence of T790M mutation in the EGFR gene as identified by a validated test.\n3. Progression of disease after treatment with a first-line EGFR-TKI (e.g., erlotinib, gefitinib, or afatinib).\n4. Age >= 18 years.\n5. ECOG performance status of 0-2.\n6. Adequate organ and marrow function as defined by study-specific laboratory tests.\n7. Ability to swallow and retain oral medication.\n8. Must have at least one measurable lesion as defined by RECIST v1.1.\n9. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.\n10. Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n1. Patients with known EGFR exon 20 insertion mutations.\n2. Prior treatment with a third-generation EGFR-TKI.\n3. Presence of any other significant genetic alterations in ALK, ROS1, or MET that could affect the progression of NSCLC.\n4. Active brain metastases or leptomeningeal metastases. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.\n5. History of severe hypersensitivity reactions to other similar compounds.\n6. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV).\n7. Any prior chemotherapy or targeted therapy for NSCLC within 14 days prior to the first dose of trial treatment.\n8. Pregnant or breastfeeding women.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"], [\"ALK alteration\"], [\"ROS1 alteration\"], [\"MET alteration\"]]}"
    },
    {
        "input": " A Multicenter, Randomized, Phase II Trial to Evaluate the Efficacy of Pembrolizumab in Combination with Carboplatin and Paclitaxel in Patients with Advanced Triple-Negative Breast Cancer (TNBC) with High PD-L1 Expression and BRCA1/2 Mutations.\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of triple-negative breast cancer (TNBC) without HER2 overexpression.\n2. Documented BRCA1 or BRCA2 mutation.\n3. PD-L1 expression in tumor cells >= 1% as determined by an FDA-approved test.\n4. Locally advanced (unresectable) or metastatic disease.\n5. No prior systemic therapy for advanced disease.\n6. Age >= 18 years.\n7. ECOG performance status of 0-1.\n8. Adequate organ function as defined by study-specific laboratory tests.\n9. At least one measurable lesion as defined by RECIST v1.1.\n10. Women of childbearing potential must have a negative pregnancy test within 7 days prior to initiation of study treatment and agree to use effective contraception during the study and for at least 120 days after the last dose of study medication.\n\nExclusion Criteria:\n1. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).\n2. Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).\n4. Active brain metastases or leptomeningeal metastases. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids.\n5. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n6. An active infection requiring systemic therapy.\n7. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n8. Known history of HIV (HIV 1/2 antibodies).\n9. Known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA [qualitative] is detected).",
        "output": "{\"inclusion_biomarker\": [[\"BRCA1 mutation\", \"BRCA2 mutation\"], [\"PD-L1 expression\"]], \"exclusion_biomarker\": [[\"HER2 overexpression\"]]}"
    },
    {
        "input": " A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy of ATZ199 in Patients with MET Exon 14 Skipping Mutation-Positive Advanced Non-Small Cell Lung Cancer\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is locally advanced, recurrent, or metastatic and not amenable to curative therapy.\n2. Documented MET exon 14 skipping mutation in tumor tissue or plasma as determined by a validated next-generation sequencing (NGS) assay.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0-2.\n5. Measurable disease according to RECIST v1.1 criteria.\n6. Adequate organ function as defined by study-specific laboratory tests.\n7. Prior treatment with at least one line of systemic therapy for advanced/metastatic NSCLC, or patient is deemed unsuitable for standard treatment options.\n8. Ability to provide informed consent and willingness to comply with the study protocol.\n9. Women of childbearing potential and men must agree to use adequate contraception during the study and for a specified period after the last dose of study drug.\n\nExclusion Criteria:\n1. Known mutations in EGFR, ALK, ROS1, or BRAF V600E that are amenable to targeted therapy.\n2. Active brain metastases or leptomeningeal disease. Patients with previously treated brain metastases that are stable for at least 4 weeks following treatment and without requirement of steroids are eligible.\n3. History of another primary malignancy within 3 years prior to enrollment, except for malignancies with a negligible risk of metastasis or death.\n4. Significant cardiovascular disease, such as heart failure meeting New York Heart Association Class III or IV criteria, uncontrolled hypertension, or recent myocardial infarction.\n5. Known hypersensitivity to any component of ATZ199 or similar compounds.\n6. Participation in another clinical study with an investigational product during the last 4 weeks before enrollment.\n7. Pregnant or breastfeeding women.\n8. Any medical, psychological, or social condition that may interfere with the participant's participation in the study or evaluation of the study results.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"MET exon 14 skipping mutation\"]], \"exclusion_biomarker\": [[\"EGFR mutation\"], [\"ALK mutation\"], [\"ROS1 mutation\"], [\"BRAF V600E\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of BKM120 Plus Fulvestrant in Postmenopausal Women with Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer with PIK3CA Mutations\n\nInclusion Criteria:\n1. Postmenopausal women with histologically or cytologically confirmed hormone receptor-positive, HER2-negative advanced breast cancer.\n2. Documented PIK3CA mutation in tumor tissue or plasma as determined by a validated NGS assay.\n3. Progression on or after treatment with an aromatase inhibitor in the metastatic setting or relapse while on or within one year of completing adjuvant aromatase inhibitor therapy.\n4. ECOG performance status of 0-1.\n5. Measurable disease according to RECIST v1.1 or bone lesions in the absence of measurable disease.\n6. Adequate organ and marrow function as defined by study-specific laboratory tests.\n7. Ability and willingness to swallow and retain oral medication.\n8. Written informed consent and HIPAA authorization for release of personal health information.\n\nExclusion Criteria:\n1. Prior treatment with any PI3K, AKT, or mTOR inhibitor.\n2. Known hypersensitivity to BKM120 or fulvestrant or their excipients.\n3. Active brain metastases or leptomeningeal disease. Patients with stable brain metastases after treatment are eligible.\n4. History of another malignancy within the last 3 years except for malignancies with a high probability of cure.\n5. Uncontrolled or significant cardiovascular disease, including recent myocardial infarction, congestive heart failure, unstable angina, or significant arrhythmias.\n6. Concurrent use of other anti-cancer therapy or enrollment in another clinical trial involving treatment with investigational agents within 4 weeks prior to randomization.\n7. Pregnant or breastfeeding, or intending to become pregnant during the study or within 6 weeks after the final dose.\n8. Known HIV infection, hepatitis B, or hepatitis C with active replication.\n9. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study.",
        "output": "{\"inclusion_biomarker\": [[\"HER2 negative\"], [\"PIK3CA mutation\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Multicenter, Randomized Study to Evaluate the Efficacy of Cetrelimab in Combination with Abemaciclib in Patients with Metastatic Colorectal Cancer Harboring CDK4 Amplification\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of metastatic colorectal cancer (mCRC).\n2. Documented CDK4 amplification by Next-Generation Sequencing (NGS) from a CLIA-certified laboratory.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. Measurable disease according to RECIST v1.1 criteria.\n6. Prior treatment with at least one but no more than two lines of systemic therapy for metastatic disease.\n7. Adequate bone marrow, liver, and renal function as defined by laboratory values.\n8. Ability to swallow and retain oral medication.\n9. Written informed consent and HIPAA authorization for release of personal health information.\n\nExclusion Criteria:\n1. Prior treatment with CDK4/6 inhibitors or immune checkpoint inhibitors.\n2. Presence of other genomic aberrations known to drive cancer progression in colorectal cancer, including but not limited to KRAS, NRAS, and BRAF mutations.\n3. Active brain metastases or leptomeningeal metastases.\n4. History of another primary malignancy that is clinically significant or requires active intervention.\n5. Uncontrolled or significant cardiovascular disease, including recent myocardial infarction, congestive heart failure, unstable angina, or serious cardiac arrhythmias.\n6. Known active infection with HIV, HBV, or HCV.\n7. Pregnant or breastfeeding women.\n8. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"CDK4 amplification\"]], \"exclusion_biomarker\": [[\"KRAS mutation\"], [\"NRAS mutation\"], [\"BRAF mutation\"]]}"
    },
    {
        "input": " A Phase I/II Study of AZD9291 (Osimertinib) with or without Bevacizumab in EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer Patients after Failure of EGFR Tyrosine Kinase Inhibitor\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) with stage IV disease according to the AJCC 8th edition.\n2. Documented T790M mutation in the EGFR gene as detected by a CLIA-certified laboratory.\n3. Progression during or after treatment with an EGFR tyrosine kinase inhibitor (TKI).\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. At least one measurable lesion as defined by RECIST v1.1.\n7. Adequate organ and marrow function as defined by laboratory values.\n8. Non-pregnant and non-nursing. Participants of childbearing potential must agree to use effective contraception during the study and for a defined period after the last dose of study drug.\n\nExclusion Criteria:\n1. Prior treatment with Osimertinib or any other EGFR T790M-specific inhibitor.\n2. Presence of exon 20 insertion mutations in the EGFR gene.\n3. Known symptomatic brain metastases requiring steroids, or brain metastases that are not stable for > 4 weeks prior to starting therapy.\n4. Prior therapy with anti-angiogenic agents, including bevacizumab, within 4 weeks of starting the study.\n5. History of interstitial lung disease or pneumonitis.\n6. Uncontrolled hypertension despite optimal medical management.\n7. Significant bleeding disorders or gastrointestinal perforation within 6 months prior to starting therapy.\n8. Any other condition that, in the investigator\u2019s opinion, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study.",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A Phase II, Open-Label Study Evaluating the Efficacy and Safety of AZD9291 (Osimertinib) in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with T790M Mutation Positive and Specific EGFR Sensitizing Mutations Post-Platinum-Based Chemotherapy\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of NSCLC that is locally advanced or metastatic.\n2. Documented evidence of T790M mutation and at least one of the specific EGFR sensitizing mutations (exon 19 deletions or L858R substitution mutations) in the tumor tissue or plasma.\n3. Disease progression during or after treatment with at least one platinum-based chemotherapy regimen.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. Adequate bone marrow, liver, and renal function.\n7. At least one measurable lesion as defined by RECIST v1.1.\n8. Ability to swallow and retain oral medication.\n9. Willingness to provide tissue from a newly obtained biopsy of a tumor lesion.\n10. Women of childbearing potential must agree to use adequate contraception.\n\nExclusion Criteria:\n1. Presence of any other known mutation in EGFR that is known to confer resistance to AZD9291 (e.g., exon 20 insertions).\n2. Previous treatment with any EGFR TKI targeting T790M mutation.\n3. Active brain metastases or leptomeningeal metastases.\n4. History of interstitial lung disease or pneumonitis.\n5. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.\n6. Any other malignancies within the last 5 years except for tumors with a negligible risk of metastasis or death.\n7. Current participation in another clinical study with an investigational product.\n8. Pregnant or breastfeeding women.\n9. Known hypersensitivity to AZD9291 or any of the excipients of this product.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\", \"EGFR exon 19 deletion\"], [\"EGFR T790M\", \"EGFR L858R\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC) in Patients with Homologous Recombination Repair (HRR) Gene Mutations\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of mCRPC.\n2. Presence of a deleterious or suspected deleterious mutation in at least one of the HRR genes (e.g., BRCA1, BRCA2, ATM).\n3. Progression of disease on or after one novel hormone therapy (e.g., enzalutamide, apalutamide).\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ function as defined by study-specific laboratory tests.\n7. Patients must be suitable for treatment with abiraterone acetate and prednisone according to the label.\n8. Measurable disease according to RECIST v1.1 or bone lesions on bone scan.\n9. Ability to swallow and retain oral medication.\n10. Men must agree to use contraception during the study and for 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n1. Prior treatment with PARP inhibitors, including niraparib, or with abiraterone acetate in the mCRPC setting.\n2. Known active brain metastases or leptomeningeal disease.\n3. History of another malignancy within the last 3 years, except for tumors with a negligible risk of metastasis or death.\n4. Active or symptomatic viral hepatitis or chronic liver disease.\n5. History of myocardial infarction or unstable angina within 6 months prior to enrollment.\n6. Uncontrolled hypertension or any condition that, in the opinion of the investigator, would preclude participation in this study.\n7. Known gastrointestinal disorders or conditions that could affect the absorption of study drugs.\n8. Concurrent use of other anticancer therapy.\n9. Patients who are unable to comply with the study protocol.\n10. Known hypersensitivity to niraparib, abiraterone acetate, prednisone, or any of their excipients.",
        "output": "{\"inclusion_biomarker\": [[\"BRCA1 mutation\", \"BRCA2 mutation\", \"ATM mutation\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-label Study to Evaluate the Efficacy and Safety of AZD9291 (Osimertinib) in Combination with Bevacizumab in Patients with EGFR T790M Mutation-positive, Non-Squamous, Non-Small Cell Lung Cancer (NSCLC) After Progression on a Previous EGFR-TKI\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of stage IIIB/IV non-squamous NSCLC.\n2. Documented evidence of EGFR T790M mutation identified post-progression on first or second-generation EGFR-TKI therapy.\n3. At least one measurable lesion as defined by RECIST v1.1.\n4. ECOG performance status of 0 or 1.\n5. Age \u2265 18 years.\n6. Adequate organ and marrow function.\n7. Patients must be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.\n8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after completion of study treatment.\n\nExclusion Criteria:\n1. Prior treatment with any third-generation EGFR-TKI or anti-VEGF therapy.\n2. Presence of EGFR exon 20 insertion mutations.\n3. Co-existing mutations in ALK, ROS1, or BRAF V600E.\n4. Known symptomatic brain metastases requiring steroids. Patients with previously treated brain metastases may participate provided they are stable.\n5. Significant cardiovascular event (e.g., myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease \u22652) within 3 months prior to enrollment.\n6. History of interstitial lung disease or pneumonitis.\n7. Uncontrolled hypertension.\n8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.\n9. Known hypersensitivity to AZD9291 (osimertinib) or bevacizumab or any of their excipients.\n10. Pregnant or breastfeeding women.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"], [\"ALK mutation\"], [\"ROS1 mutation\"], [\"BRAF V600E\"]]}"
    },
    {
        "input": " A Randomized, Double-blind, Placebo-controlled Phase III Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Homologous Recombination Repair (HRR) Gene Alterations\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of metastatic castration-resistant prostate cancer (mCRPC).\n2. Documented alterations in at least one of the following HRR genes: BRCA1, BRCA2, ATM, PALB2, CHEK2, FANCA, RAD51, and other genes involved in the HRR pathway.\n3. Progression on androgen deprivation therapy with a GnRH analog or orchiectomy (surgical or medical castration).\n4. ECOG performance status of 0 or 1.\n5. Age \u2265 18 years.\n6. Adequate organ and marrow function.\n7. Patients must agree to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.\n8. Male patients and their female partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n1. Prior treatment with PARP inhibitors or abiraterone acetate.\n2. Known mutations in MMR genes (e.g., MLH1, MSH2, MSH6, PMS2) or diagnosis of Lynch syndrome.\n3. Presence of symptomatic brain metastases or leptomeningeal disease.\n4. Significant cardiovascular event (e.g., myocardial infarction, unstable angina, stroke) within 6 months prior to enrollment.\n5. History of another malignancy within 3 years prior to enrollment, except for adequately treated non-melanoma skin cancer or other non-invasive carcinomas.\n6. Uncontrolled hypertension or any other uncontrolled serious medical or psychiatric illness.\n7. Major surgical procedure within 28 days prior to enrollment.\n8. Known hypersensitivity to niraparib, abiraterone acetate, prednisone, or any of their excipients.\n9. Patients who are unable to swallow orally administered medication or have gastrointestinal disorders likely to interfere with absorption of the study medication.\n10. Participation in another clinical study with an investigational product during the last 4 weeks before enrollment.",
        "output": "{\"inclusion_biomarker\": [[\"BRCA1 alteration\"], [\"BRCA2 alteration\"], [\"ATM alteration\"], [\"PALB2 alteration\"], [\"CHEK2 alteration\"], [\"FANCA alteration\"], [\"RAD51 alteration\"], [\"HRR pathway alteration\"]], \"exclusion_biomarker\": [[\"MLH1 mutation\"], [\"MSH2 mutation\"], [\"MSH6 mutation\"], [\"PMS2 mutation\"]]}"
    },
    {
        "input": " A Phase II, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of AZD9291 Versus Standard of Care Chemotherapy in Patients with EGFR T790M Mutation-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed Following Prior Therapy with an EGFR-TKI.\n\nInclusion Criteria:\n1. Confirmed diagnosis of locally advanced or metastatic NSCLC that is not amenable to curative therapy.\n2. Documented evidence of tumor harboring an EGFR T790M mutation as identified by a validated test in a CLIA-certified laboratory (or local equivalent).\n3. Progression on or after treatment with an FDA-approved EGFR-TKI therapy.\n4. At least one measurable lesion as defined by RECIST 1.1.\n5. ECOG performance status of 0 or 1.\n6. Age \u2265 18 years.\n7. Adequate bone marrow, liver, and renal function.\n8. Women of childbearing potential must agree to use adequate contraception from the time of screening until 90 days after the last dose of study drug.\n\nExclusion Criteria:\n1. Prior treatment with AZD9291 or other third-generation EGFR-TKI.\n2. Presence of exon 20 insertion mutations in the EGFR gene.\n3. Treatment with more than one line of chemotherapy for advanced NSCLC.\n4. Known symptomatic central nervous system metastases requiring steroids, or metastases that are neurologically unstable or requiring increasing doses of steroids to control symptoms.\n5. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.\n6. History of another primary malignancy within the last 3 years, except for malignancies with a negligible risk of metastasis or death.\n7. Known hypersensitivity to AZD9291 or any of its excipients.\n8. Participation in another clinical study with an investigational product during the last 4 weeks.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study of BGB-290 (Pamiparib) in Combination with Temozolomide in Patients with Recurrent or Metastatic Colorectal Cancer with a Homologous Recombination Repair (HRR) Gene Mutation.\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of colorectal cancer that is metastatic or unresectable and for which standard curative measures do not exist.\n2. Documented HRR gene mutation (including but not limited to BRCA1, BRCA2, ATM, PALB2) in tumor tissue by a CLIA-certified laboratory (or local equivalent).\n3. Progressed on at least one but no more than two prior chemotherapy regimens for metastatic disease.\n4. At least one measurable lesion as defined by RECIST 1.1.\n5. ECOG performance status of 0 or 1.\n6. Age \u2265 18 years.\n7. Adequate bone marrow, liver, and renal function.\n8. Willingness to avoid pregnancy or fathering children based on the use of effective contraceptive methods during the study and for 6 months after the last dose of study drug.\n\nExclusion Criteria:\n1. Prior treatment with PARP inhibitors or temozolomide.\n2. Known mutations in the MMR genes (MLH1, MSH2, MSH6, PMS2) or diagnosis of Lynch syndrome.\n3. Active central nervous system metastases or leptomeningeal disease.\n4. History of another primary malignancy within the last 3 years, with the exception of cancers with a negligible risk of metastasis or death.\n5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n6. Pregnant or breastfeeding women.\n7. Known history of HIV, Hepatitis B, or Hepatitis C.\n8. Any other condition that, in the investigator\u2019s opinion, would make the patient unsuitable for the study or unable to comply with dosing requirements.",
        "output": "{\"inclusion_biomarker\": [[\"HRR mutation\"], [\"BRCA1 mutation\"], [\"BRCA2 mutation\"], [\"ATM mutation\"], [\"PALB2 mutation\"]], \"exclusion_biomarker\": [[\"MLH1 mutation\"], [\"MSH2 mutation\"], [\"MSH6 mutation\"], [\"PMS2 mutation\"]]}"
    },
    {
        "input": " A Phase II, Randomized, Open-Label Study to Evaluate the Efficacy of AZD9291 combined with Bevacizumab versus AZD9291 alone in Patients with EGFR T790M Mutation-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) after Failure of First-Line EGFR TKI Therapy.\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of NSCLC that is locally advanced or metastatic.\n2. Documented evidence of EGFR T790M mutation in tumor tissue or plasma.\n3. Progression of disease after treatment with an approved first-line EGFR TKI (e.g., erlotinib, gefitinib, or afatinib).\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ and marrow function.\n7. Able and willing to undergo blood sampling for PK and PD analysis.\n8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the last dose of study treatment.\n9. Ability to swallow and retain oral medication.\n\nExclusion Criteria:\n1. Presence of EGFR exon 20 insertion mutations.\n2. Previous treatment with AZD9291 or any other EGFR T790M-specific inhibitor.\n3. Treatment with more than one line of chemotherapy for advanced NSCLC.\n4. Known symptomatic brain metastases requiring steroids. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.\n5. Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.\n6. History of another malignancy within 2 years prior to enrollment, except for adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or localized prostate cancer.\n7. Known hypersensitivity to AZD9291, bevacizumab, or any excipient of these products.\n8. Pregnant or breastfeeding women.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A Phase III, Double-Blind, Placebo-Controlled Study of Pembrolizumab in Combination with Chemotherapy in Patients with Advanced Triple-Negative Breast Cancer (TNBC) with High PD-L1 Expression and BRCA1/2 Mutations.\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of triple-negative breast cancer (TNBC) that is either locally recurrent and not amenable to resection or radiation with curative intent, or metastatic.\n2. Documented germline BRCA1 or BRCA2 mutation.\n3. PD-L1 positive tumor expression.\n4. No prior chemotherapy or targeted systemic therapy for locally recurrent or metastatic TNBC.\n5. Age \u2265 18 years.\n6. ECOG performance status of 0 or 1.\n7. Adequate organ function.\n8. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.\n9. Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n1. Known hypersensitivity to pembrolizumab or any of its excipients.\n2. Previous or concurrent cancer that is distinct in primary site or histology from TNBC except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors, or any cancer curatively treated > 5 years prior to enrollment.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years.\n4. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n5. Active infection requiring systemic therapy.\n6. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.\n7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n8. Use of other investigational drugs within 30 days or 5 half-lives, whichever is shorter, preceding the first dose of trial treatment.",
        "output": "{\"inclusion_biomarker\": [[\"BRCA1 mutation (germline)\"], [\"BRCA2 mutation (germline)\"], [\"PD-L1 expression\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " This is a Phase II, open-label, multicenter study to evaluate the efficacy and safety of the combination therapy of AZD9291 (osimertinib) and Bevacizumab in patients with EGFR T790M mutation-positive, advanced non-small cell lung cancer (NSCLC) after failure of a previous EGFR TKI.\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC.\n2. Documented evidence of EGFR T790M mutation in tumor tissue or plasma.\n3. Progression during or after treatment with an FDA-approved EGFR TKI.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ and marrow function.\n7. Measureable disease according to RECIST v1.1.\n8. Ability to understand and willingness to sign a written informed consent document.\n9. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days after completion of administration.\n\nExclusion Criteria:\n1. Prior treatment with any systemic therapy for NSCLC other than an EGFR TKI.\n2. Known mutations in EGFR other than T790M or sensitizing mutations (e.g., exon 19 deletion, L858R).\n3. Presence of any other genetic aberrations known to drive NSCLC progression (e.g., ALK rearrangement, ROS1 fusion).\n4. Prior treatment with Bevacizumab or other VEGF/VEGFR inhibitors.\n5. History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.\n6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).\n7. Presence of symptomatic central nervous system (CNS) metastases or leptomeningeal carcinomatosis.\n8. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina.\n9. Known history of severe bleeding or coagulation disorders.\n10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to beginning study treatment.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR mutation\"], [\"ALK rearrangement\"], [\"ROS1 fusion\"]]}"
    },
    {
        "input": " A Phase III, randomized, placebo-controlled trial of Pembrolizumab in combination with chemotherapy versus chemotherapy alone in patients with advanced triple-negative breast cancer (TNBC) with high PD-L1 expression.\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of triple-negative breast cancer (TNBC) (ER negative, PR negative, and HER2 negative).\n2. Advanced (metastatic or unresectable) TNBC.\n3. PD-L1 positive tumor expression defined as a Combined Positive Score (CPS) \u2265 10 as determined by an FDA-approved test.\n4. No prior systemic therapy for advanced disease.\n5. Age \u2265 18 years.\n6. ECOG performance status of 0 or 1.\n7. Adequate organ function.\n8. Measureable disease according to RECIST v1.1.\n9. Women of childbearing potential must have a negative pregnancy test within 7 days prior to initiation of treatment and agree to use effective contraception during the treatment period and for at least 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n1. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).\n2. Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years.\n4. Active CNS metastases and/or carcinomatous meningitis.\n5. History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n6. Active infection requiring systemic therapy.\n7. Pregnant or breastfeeding women.\n8. Known history of Human Immunodeficiency Virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n9. Any other medical, psychological, or social conditions that may interfere with the participant's participation in the study or evaluation of the study results.",
        "output": "{\"inclusion_biomarker\": [[\"ER negative\", \"PR negative\", \"HER2 negative\", \"PD-L1 expression\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, open-label study evaluating the efficacy and safety of AZD9291 (osimertinib) in combination with bevacizumab in patients with T790M-positive advanced non-small cell lung cancer (NSCLC) after progression on first-line EGFR-TKI therapy.\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of NSCLC with radiologically documented progression on or after first-line EGFR-TKI therapy.\n2. Presence of the EGFR T790M mutation in tumor tissue or plasma as detected by an approved test.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. At least one measurable lesion as defined by RECIST v1.1.\n6. Adequate organ and marrow function as defined by laboratory values.\n7. Ability to provide written informed consent and comply with study procedures.\n8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the completion of therapy.\n\nExclusion Criteria:\n1. Prior treatment with any drug targeting EGFR T790M mutation or angiogenesis (e.g., bevacizumab, ramucirumab).\n2. Presence of exon 20 insertion mutations in the EGFR gene.\n3. Known symptomatic brain metastases requiring steroids. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.\n4. History of another primary malignancy within the last 3 years, except for malignancies with a negligible risk of metastasis or death (e.g., adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer).\n5. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina.\n6. Known hypersensitivity to AZD9291 (osimertinib), bevacizumab, or any excipient in their formulations.\n7. Pregnant or breastfeeding women.\n8. Participation in another clinical study with an investigational product during the last 30 days before enrollment.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR T790M\"], [\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A randomized, double-blind, placebo-controlled Phase III study of the efficacy and safety of Pembrolizumab (MK-3475) in combination with standard chemotherapy in patients with metastatic triple-negative breast cancer (TNBC) with a PD-L1 expression \u2265 1%.\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of metastatic TNBC, not amenable to curative surgery or radiotherapy.\n2. PD-L1 expression \u2265 1% in tumor cells or immune cells as determined by an FDA-approved test.\n3. No prior systemic therapy for metastatic disease. Patients may have received prior neoadjuvant/adjuvant chemotherapy if completed more than 6 months prior to the first evidence of metastatic disease.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. Measurable disease as per RECIST v1.1.\n7. Adequate organ function.\n8. Female patients of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication and must agree to use effective contraception during the study and for at least 120 days after the last dose of study medication.\n\nExclusion Criteria:\n1. Known hypersensitivity to pembrolizumab or any of its excipients.\n2. Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years.\n4. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).\n5. Active brain metastases or leptomeningeal metastases. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.\n6. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n7. Pregnant or breastfeeding women.\n8. Known history of HIV (HIV 1/2 antibodies).\n9. Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).\n10. Current or prior use of immunosuppressive medication within 14 days before the first dose of trial treatment.",
        "output": "{\"inclusion_biomarker\": [[\"PD-L1 expression\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label Study of the Efficacy and Safety of AZD9291 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with EGFR T790M Mutation After Failure of an EGFR TKI\n;\n;\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.\n2. Documented evidence of EGFR T790M mutation in tumor tissue or plasma after progression on a first- or second-generation EGFR TKI.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0-2.\n5. At least one measurable lesion as defined by RECIST 1.1.\n6. Adequate organ and marrow function as outlined by study-specific laboratory criteria.\n7. Ability to swallow and retain oral medication.\n8. Willingness to provide tissue samples for genetic analysis if available. If not, willingness to undergo a biopsy.\n9. Women of childbearing potential must have a negative pregnancy test prior to start of dosing and agree to use effective contraception during the study and for 6 months after the last dose of study drug.\n\nExclusion Criteria:\n1. Patients with a known sensitizing EGFR mutation (e.g., exon 19 deletion, L858R) without a documented T790M mutation.\n2. Previous treatment with a third-generation EGFR TKI.\n3. Active brain metastases or leptomeningeal metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.\n4. History of interstitial lung disease or pneumonitis.\n5. Current use of a prohibited medication or requires any of these medications during treatment with AZD9291.\n6. Other malignancy within 3 years prior to starting study treatment, except for adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or localized prostate cancer with a current PSA <0.1 ng/ml.\n7. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study.\n8. Pregnant or breastfeeding women.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 19 deletion\"], [\"EGFR L858R\"], [\"EGFR T790M\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind Phase III Study of Pembrolizumab versus Placebo in Melanoma Patients with High-Risk BRAF V600 Mutation-Positive Tumors After Complete Resection\n;\n;\nInclusion Criteria:\n1. Histologically confirmed melanoma with a BRAF V600 mutation.\n2. Complete resection of melanoma with high-risk features (Stage IIB, IIC, IIIA (N1a/N2a), IIIB, IIIC, or IV according to the 8th Edition AJCC staging system) within 12 weeks prior to randomization.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. Adequate organ function as defined by study-specific criteria.\n6. Negative pregnancy test for females of childbearing potential and agreement to use effective contraception for both male and female participants during the study and for at least 120 days after the last dose of pembrolizumab.\n7. Willingness to provide tissue from an archival tumor sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.\n\nExclusion Criteria:\n1. Presence of any unresected melanoma.\n2. Previous systemic therapy for melanoma, including BRAF or MEK inhibitors, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years.\n4. A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids and adrenal replacement doses \u2264 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.\n5. History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n6. Active CNS metastases and/or carcinomatous meningitis.\n7. Severe hypersensitivity reaction to pembrolizumab or any of its excipients.\n8. Known history of Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C; or any uncontrolled infection.\n9. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.",
        "output": "{\"inclusion_biomarker\": [[\"BRAF V600\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label Study to Assess the Efficacy of AZD9291 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with T790M Mutation Positive and EGFR Sensitizing Mutation Post-Platinum-Based Chemotherapy and EGFR-TKI Therapy.\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.\n2. Documented evidence of T790M mutation and an EGFR sensitizing mutation (exon 19 deletions or exon 21 L858R substitution mutations).\n3. Disease progression during or after treatment with at least one platinum-based chemotherapy regimen and one EGFR-TKI therapy.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0-2.\n6. Adequate organ and marrow function as defined by study-specific laboratory tests.\n7. Non-pregnant and non-nursing. Participants of childbearing potential must agree to use effective contraception during the study and for a defined period following the last dose of study drug.\n8. Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n1. Presence of any other mutation in EGFR not specified in the inclusion criteria (e.g., exon 20 insertions).\n2. Treatment with more than two lines of chemotherapy for advanced/metastatic NSCLC.\n3. Prior treatment with AZD9291 or other third-generation EGFR-TKIs.\n4. Known symptomatic brain metastases requiring steroids. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.\n5. Active second malignancy that might interfere with the assessment of efficacy or safety of the trial treatment.\n6. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.\n7. History of hypersensitivity to AZD9291 or any excipient of the product.\n8. Pregnant or breastfeeding women.\n9. Participation in another clinical trial with an investigational product within 30 days prior to enrollment.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\", \"EGFR exon 19 deletion\"], [\"EGFR T790M\", \"EGFR exon 21 L858R\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " Multicenter, Randomized Phase II Study Evaluating the Efficacy of Nivolumab Plus Ipilimumab in Patients with Hypermutated Metastatic Colorectal Cancer Identified by High Microsatellite Instability (MSI-H) or Mismatch Repair Deficiency (dMMR).\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of metastatic colorectal cancer.\n2. Presence of high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) as confirmed by a CLIA-certified laboratory.\n3. Failed or intolerant to at least one prior line of systemic treatment for metastatic disease.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0-1.\n6. Measurable disease according to RECIST v1.1 criteria.\n7. Adequate organ function as defined by study-specific laboratory tests.\n8. Ability to provide written informed consent and comply with study procedures.\n9. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for a defined period after the last dose of study drug.\n\nExclusion Criteria:\n1. Known BRAF V600E mutation.\n2. Prior treatment with any checkpoint inhibitor, including PD-1, PD-L1, or CTLA-4 inhibitors.\n3. Active autoimmune disease requiring systemic treatment within the past 2 years or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.\n4. Known history of, or any evidence of active, non-infectious pneumonitis.\n5. Active infection requiring systemic therapy.\n6. Presence of any other genetic syndrome associated with colorectal cancer (e.g., Lynch syndrome, Familial Adenomatous Polyposis).\n7. Active CNS metastases and/or carcinomatous meningitis.\n8. History of allogeneic tissue/solid organ transplant.\n9. Concurrent participation in another therapeutic clinical trial.\n10. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.",
        "output": "{\"inclusion_biomarker\": [[\"High Microsatellite Instability\"], [\"Mismatch Repair Deficiency\"]], \"exclusion_biomarker\": [[\"BRAF V600E\"]]}"
    },
    {
        "input": " A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of AZD9291 (Osimertinib) in Combination with Bevacizumab in Patients with EGFR T790M Mutation-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed Following Prior EGFR TKI Therapy.\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC that is locally advanced or metastatic.\n2. Documented evidence of T790M mutation in the EGFR gene as detected by a validated test in a CLIA-certified laboratory (or equivalent).\n3. Progression during or after treatment with an FDA-approved EGFR TKI.\n4. At least one measurable lesion as defined by RECIST v1.1.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ and marrow function as outlined in the study protocol.\n7. Age \u2265 18 years.\n8. Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n1. Presence of EGFR exon 20 insertion mutations or other resistance mutations not compatible with T790M-targeted therapy.\n2. Prior treatment with an anti-angiogenic agent or any other investigational agents within 28 days of the first dose of study treatment.\n3. History of another primary malignancy within the last 5 years, with the exception of cured non-melanoma skin cancer, curatively treated in situ cancer, or other solid tumors curatively treated with no evidence of disease for \u2265 5 years.\n4. Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.\n5. Any evidence of interstitial lung disease or pneumonitis.\n6. Known hypersensitivity to AZD9291 (osimertinib) or bevacizumab or any of their excipients.\n7. Pregnant or breastfeeding women, or women of childbearing potential not employing an effective method of birth control.\n8. Prior major surgery within 4 weeks of the first dose of study treatment.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Nivolumab in Combination with Ipilimumab Versus Placebo in Patients with Resected Stage III or IV Melanoma with a BRAF V600 Mutation\n\nInclusion Criteria:\n1. Histologically confirmed melanoma that is classified as stage III or IV according to the AJCC 8th edition melanoma staging system.\n2. Presence of a BRAF V600 mutation as confirmed by a CLIA-certified (or equivalent) laboratory.\n3. Complete resection of melanoma with no evidence of disease.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ function as defined by study-specific laboratory tests.\n7. Willingness to avoid pregnancy or fathering children for the duration of the study and for 23 weeks after the last dose of study drug.\n\nExclusion Criteria:\n1. Prior systemic therapy for melanoma, including BRAF or MEK inhibitors.\n2. Presence of any other known BRAF mutation not V600 or any NRAS mutations.\n3. Active or history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents, except for syndromes that do not require systemic treatment.\n4. History of another primary malignancy that has been diagnosed or required therapy within the past 3 years, with the exception of adequately treated basal or squamous cell skin cancer or carcinoma in situ.\n5. Active brain metastases or leptomeningeal metastases.\n6. History of severe hypersensitivity reaction to any monoclonal antibody.\n7. Pregnant or breastfeeding women, or women of childbearing potential not using an effective method of contraception.\n8. Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.",
        "output": "{\"inclusion_biomarker\": [[\"BRAF V600\"]], \"exclusion_biomarker\": [[\"BRAF non-V600\"], [\"NRAS mutation\"]]}"
    },
    {
        "input": " A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of AZD9291 in Combination with Bevacizumab for EGFR-mutant Non-Small Cell Lung Cancer (NSCLC) After Progression on a Previous EGFR-TKI\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC) with documented evidence of EGFR sensitizing mutations (e.g., Exon 19 deletions, L858R).\n2. Patients must have progressed on or after treatment with an approved EGFR-TKI.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. Measurable disease according to RECIST v1.1 criteria.\n6. Adequate bone marrow, liver, and renal function.\n7. Willingness to undergo blood sampling for pharmacokinetic (PK) and pharmacodynamic (PD) analysis.\n8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.\n9. Ability to swallow and retain oral medication.\n\nExclusion Criteria:\n1. Presence of T790M mutation.\n2. Previous treatment with AZD9291 or bevacizumab.\n3. Known symptomatic brain metastases requiring steroids. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.\n4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.\n5. History of another primary malignancy except for malignancies that do not require active therapy or were treated curatively and have no evidence of disease for \u2265 5 years.\n6. Pregnant or breastfeeding women.\n7. Known hypersensitivity to AZD9291, bevacizumab, or any of their excipients.\n8. Interstitial lung disease or a history of pneumonitis that required steroid treatment.\n9. Current use of a prohibited medication that cannot be discontinued at least 2 weeks prior to the start of treatment with AZD9291.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR Exon 19 deletion\"], [\"EGFR L858R\"]], \"exclusion_biomarker\": [[\"EGFR T790M\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Nivolumab in Combination with Ipilimumab versus Placebo in Patients with Stage IV Mismatch Repair Deficient (dMMR) or Microsatellite Instability High (MSI-H) Colorectal Cancer\n\nInclusion Criteria:\n1. Histologically confirmed colorectal adenocarcinoma that is Stage IV.\n2. Documented dMMR or MSI-H status by a CLIA-certified (or equivalent) assay.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. Measurable disease as defined by RECIST 1.1.\n6. Adequate organ and marrow function.\n7. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 23 weeks following the last dose of study drug.\n8. Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n1. Known BRAF V600E mutation.\n2. Prior treatment with any checkpoint inhibitor or any other investigational agents for metastatic colorectal cancer.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years.\n4. A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.\n5. History of another primary malignancy except for malignancies that do not require active therapy, were treated curatively and have no evidence of disease for \u2265 5 years.\n6. Active CNS metastases and/or carcinomatous meningitis.\n7. Known history of Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C.\n8. History of severe hypersensitivity reaction to any monoclonal antibody.\n9. Pregnant or breastfeeding women.\n10. Any other medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.",
        "output": "{\"inclusion_biomarker\": [[\"Mismatch Repair Deficient\"], [\"High Microsatellite Instability\"]], \"exclusion_biomarker\": [[\"BRAF V600E\"]]}"
    },
    {
        "input": " A Phase II, Open-Label Study Evaluating the Efficacy of AZD6738 in Combination with Olaparib in Patients with Advanced Solid Tumors Harboring Homologous Recombination Repair (HRR) Gene Mutations\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed advanced solid tumors with documented Homologous Recombination Repair (HRR) gene mutations (including but not limited to BRCA1, BRCA2, ATM, PALB2, RAD51).\n2. Age \u2265 18 years.\n3. ECOG performance status of 0 or 1.\n4. Measurable disease according to RECIST 1.1 criteria.\n5. Patients must have progressed following standard therapy or for whom no standard therapy exists.\n6. Adequate bone marrow, liver, and renal function.\n7. Willingness to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.\n8. Patients with germline BRCA1/2 mutations must have received prior therapy with a PARP inhibitor.\n9. Ability to swallow oral medications.\n\nExclusion Criteria:\n1. Patients with a known hypersensitivity to AZD6738, Olaparib, or any of their excipients.\n2. Active brain metastases or leptomeningeal disease. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.\n3. History of another primary malignancy within the last 3 years, with the exceptions of non-melanoma skin cancer and carcinoma in situ.\n4. Concurrent use of other anticancer therapy.\n5. Major surgery within 4 weeks prior to starting study treatment.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n7. Pregnant or breastfeeding women. Women of childbearing potential must agree to use adequate contraception from the time of screening until 6 months after the last dose of study treatment.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"HRR mutation\"], [\"BRCA1 mutation\"], [\"BRCA2 mutation\"], [\"ATM mutation\"], [\"PALB2 mutation\"], [\"RAD51 mutation\"], [\"BRCA1 mutation (germline)\"], [\"BRCA2 mutation (germline)\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Pembrolizumab in Combination with Chemotherapy in Frontline Treatment of MSI-H/dMMR Metastatic Colorectal Cancer with Assessment of Circulating Tumor DNA as a Predictive Biomarker\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of metastatic colorectal cancer (mCRC) with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) as determined by an FDA-approved test.\n2. No prior systemic therapy for metastatic disease.\n3. Age \u2265 18 years.\n4. ECOG performance status 0 or 1.\n5. Measurable disease according to RECIST 1.1 criteria.\n6. Adequate organ function.\n7. Patients must have circulating tumor DNA (ctDNA) assessed at baseline as a predictive biomarker.\n8. Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n1. Known additional malignancy that is progressing or requires active treatment within the past 3 years, with the exception of basal cell carcinoma of the skin or cervical carcinoma in situ.\n2. Active autoimmune disease that has required systemic treatment in the past 2 years.\n3. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n4. Active infection requiring systemic therapy.\n5. Known history of Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS).\n6. Known history of Hepatitis B (HBV) or Hepatitis C (HCV) infection.\n7. Concurrent use of other investigational drugs.\n8. Pregnant or breastfeeding women. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 120 days after the last dose of study medication.",
        "output": "{\"inclusion_biomarker\": [[\"high microsatellite instability\"], [\"mismatch repair deficiency\"], [\"circulating tumor DNA\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II Study Evaluating the Efficacy of AZD9291 in Combination with Bevacizumab in Patients with EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC) after Progression on First-Line EGFR TKIs\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC with an activating EGFR mutation (exon 19 deletion or exon 21 L858R substitution).\n2. Progression of disease after treatment with a first-line EGFR TKI.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0-2.\n5. Measurable disease according to RECIST v1.1.\n6. Adequate organ and marrow function.\n7. EGFR T790M mutation status must be determined prior to enrollment. Only patients with T790M mutation-negative tumors are eligible.\n8. Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n1. Prior treatment with AZD9291 or any other EGFR TKI after first-line therapy.\n2. Prior treatment with anti-VEGF therapy or bevacizumab.\n3. Presence of EGFR T790M mutation.\n4. Presence of other actionable genomic alterations known to confer resistance to EGFR TKIs (e.g., MET amplification, HER2 amplification).\n5. Known symptomatic brain metastases requiring steroids, or brain metastases that are not stable for > 4 weeks prior to start of study treatment.\n6. History of interstitial lung disease or pneumonitis.\n7. Uncontrolled hypertension (>150/100 mmHg despite optimal medical management).\n8. Significant cardiovascular disease, including previous myocardial infarction within 3 months, unstable angina, or congestive heart failure of New York Heart Association Grade \u2265 II.\n9. Pregnant or breastfeeding women.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR exon 19 deletion\", \"EGFR exon 21 L858R\"]], \"exclusion_biomarker\": [[\"EGFR T790M\"], [\"MET amplification\"], [\"HER2 amplification\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Pembrolizumab in Combination with Chemotherapy in Frontline Metastatic Colorectal Cancer Patients with High Microsatellite Instability (MSI-H) or Mismatch Repair Deficiency (dMMR)\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of metastatic colorectal adenocarcinoma.\n2. MSI-H or dMMR status confirmed by PCR or IHC, respectively.\n3. No prior systemic therapy for metastatic disease.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. Measurable disease according to RECIST v1.1.\n7. Adequate organ and marrow function.\n8. Ability to swallow and retain oral medication.\n9. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 120 days after the last dose of study treatment.\n\nExclusion Criteria:\n1. Known BRAF V600E mutation.\n2. Prior treatment with immunotherapy, including PD-1, PD-L1, or CTLA-4 inhibitors.\n3. Active autoimmune disease requiring systemic treatment within the past 2 years or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.\n4. History of non-infectious pneumonitis that required steroids or current pneumonitis.\n5. Presence of known brain metastases or leptomeningeal disease.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n7. Pregnant or breastfeeding women.\n8. Known history of HIV (HIV 1/2 antibodies).\n9. Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).\n10. Receipt of a live vaccine within 30 days prior to the first dose of trial treatment.",
        "output": "{\"inclusion_biomarker\": [[\"High Microsatellite Instability\"], [\"Mismatch Repair Deficiency\"]], \"exclusion_biomarker\": [[\"BRAF V600E\"]]}"
    },
    {
        "input": " A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of AZD4547 in Patients with Advanced Solid Tumors Harboring FGFR Gene Aberrations\n\nIn this study, the focus is on patients with advanced solid tumors that have genetic alterations in the Fibroblast Growth Factor Receptor (FGFR) genes. The primary objective is to assess the clinical benefit of AZD4547, a selective FGFR inhibitor, in this genetically defined patient population.\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of advanced solid tumors with documented FGFR1, FGFR2, or FGFR3 gene aberrations (mutations or fusions).\n2. Age \u2265 18 years.\n3. ECOG performance status of 0 or 1.\n4. Measurable disease according to RECIST v1.1.\n5. Previous treatment with at least one line of systemic therapy for advanced disease or for whom no standard therapy exists.\n6. Adequate bone marrow, liver, and renal function.\n7. Ability to swallow and retain oral medication.\n8. Willingness to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.\n9. Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during the study and for 6 months after the last dose of study drug.\n\nExclusion Criteria:\n1. Prior treatment with any FGFR inhibitors.\n2. Presence of FGFR gene aberrations known to confer resistance to AZD4547.\n3. Active brain metastases or leptomeningeal disease. Patients with previously treated brain metastases may participate provided they are stable, without evidence of disease progression for at least 4 weeks.\n4. Concurrent enrollment in another clinical trial involving investigational drug treatment or off-label drug use.\n5. Significant cardiovascular event (e.g., myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease \u22652) within 3 months prior to the first dose of study treatment.\n6. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.\n7. Pregnant or breastfeeding women.\n8. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"FGFR1 aberration\"], [\"FGFR2 aberration\"], [\"FGFR3 aberration\"]], \"exclusion_biomarker\": [[\"FGFR aberration\"]]}"
    },
    {
        "input": " A Randomized Phase III Study to Evaluate the Efficacy of Temozolomide in Combination with Olaparib for Patients with Relapsed SCLC with Specific ATM Mutations\n\nThis trial investigates the combination of temozolomide and olaparib, a PARP inhibitor, in patients with relapsed small cell lung cancer (SCLC) who have ATM mutations. The primary endpoint is progression-free survival, with overall survival, response rate, and safety as secondary endpoints.\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) that is relapsed after platinum-based chemotherapy.\n2. Documented ATM mutation in the tumor tissue via NGS or other validated methods.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0-2.\n5. Measurable disease according to RECIST v1.1.\n6. Adequate bone marrow, liver, and renal function.\n7. Previous treatment with at least one line of systemic therapy for SCLC.\n8. Ability to swallow and retain oral medication.\n9. Signed informed consent form (ICF) indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.\n\nExclusion Criteria:\n1. Treatment with more than three lines of chemotherapy for relapsed disease.\n2. Known hypersensitivity to temozolomide, olaparib, or their excipients.\n3. Active second malignancy that requires ongoing treatment.\n4. Presence of brain metastases or leptomeningeal disease that is symptomatic or requires treatment. Patients with previously treated and stable brain metastases may be eligible.\n5. Concurrent use of other investigational drugs or participation in another clinical trial involving treatment within 30 days prior to enrollment.\n6. Significant cardiovascular disease such as heart failure meeting NYHA class 3 or 4, uncontrolled angina, myocardial infarction, or stroke within 6 months prior to enrollment, or clinically significant arrhythmias requiring medication.\n7. Known HIV infection with a CD4 count <350 cells/\u03bcL, known significant liver disease (e.g., cirrhosis, hepatitis B or C), or known active tuberculosis.\n8. Pregnant or breastfeeding women.\n9. Any condition that, in the investigator's opinion, would make the patient unsuitable for the study or unable to comply with the study requirements.",
        "output": "{\"inclusion_biomarker\": [[\"ATM mutation\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A phase II, open-label, multicenter trial to evaluate the efficacy and safety of AZD9291 (osimertinib) in combination with bevacizumab in patients with EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) after progression on a previous EGFR-TKI.\n;\n;\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of stage IIIB/IV NSCLC.\n2. Documented evidence of EGFR T790M mutation detected in tumor tissue or plasma.\n3. Progression of disease after treatment with an approved first- or second-generation EGFR-TKI.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0-1.\n6. At least one measurable lesion as defined by RECIST v1.1.\n7. Adequate organ function as defined by study-specific laboratory tests.\n8. Ability to swallow and retain oral medication.\n9. Written informed consent prior to any study-specific procedures.\n10. Women of childbearing potential must have a negative pregnancy test prior to starting treatment and agree to use effective contraception during the study and for 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n1. Patients with a known hypersensitivity to AZD9291 (osimertinib), bevacizumab, or any of the excipients.\n2. Presence of exon 19 deletion or L858R EGFR mutations without T790M mutation.\n3. Prior treatment with a third-generation EGFR-TKI or anti-VEGF therapy.\n4. Spinal cord compression or brain metastases unless asymptomatic, treated, and stable (not requiring steroids for at least 4 weeks prior to start of study treatment).\n5. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina.\n6. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting study treatment, or anticipation of the need for major surgery during the course of the study.\n7. History of another primary malignancy that is clinically significant or requires active intervention.\n8. Uncontrolled hypertension defined as systolic >150 mmHg and/or diastolic >100 mmHg.\n9. Known history of HIV, hepatitis B, or hepatitis C infection.\n10. Pregnant or breastfeeding women.\n11. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 19 deletion\"], [\"EGFR L858R\"]]}"
    },
    {
        "input": " A randomized, double-blind, placebo-controlled, phase III study to assess the efficacy and safety of pembrolizumab in combination with chemotherapy in patients with advanced triple-negative breast cancer (TNBC) harboring germline BRCA1 or BRCA2 mutations.\n;\n;\nInclusion Criteria:\n1. Histologically confirmed diagnosis of triple-negative breast cancer (ER negative, PR negative, HER2/neu negative).\n2. Documented germline BRCA1 or BRCA2 mutation.\n3. Metastatic disease or locally advanced unresectable disease.\n4. No prior systemic therapy for metastatic breast cancer (neoadjuvant or adjuvant chemotherapy is allowed if completed more than 6 months prior to enrollment).\n5. Age \u2265 18 years.\n6. ECOG performance status of 0-1.\n7. Measurable disease as per RECIST v1.1.\n8. Adequate organ function as defined by study-specific laboratory tests.\n9. Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication and must agree to use effective contraception during the study and for 120 days after the last dose of study medication.\n\nExclusion Criteria:\n1. Prior treatment with any PD-1, PD-L1, or PD-L2 inhibitor, or with an anti-CTLA-4, anti-OX40, anti-CD137, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years.\n4. Active infection requiring systemic therapy.\n5. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n6. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n8. A diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n9. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.\n10. Known history of, or any evidence of active, non-infectious pneumonitis.\n11. Known history of HIV (HIV 1/2 antibodies).\n12. Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).\n13. Received a live vaccine within 30 days of planned start of study therapy.",
        "output": "{\"inclusion_biomarker\": [[\"BRCA1 mutation (germline)\"], [\"BRCA2 mutation (germline)\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of AZD9291 in Combination with Bevacizumab in Patients with EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) After Progression on Prior EGFR-TKI Therapy\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC that is locally advanced or metastatic.\n2. Documented evidence of an EGFR T790M mutation in tumor tissue or plasma after disease progression on the most recent treatment with an approved EGFR-TKI.\n3. At least one measurable lesion as defined by RECIST 1.1 criteria.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ and marrow function as defined by study-specific laboratory tests.\n7. Patients must have recovered from all toxicities related to prior therapies to grade \u22641, except for stable sensory neuropathy \u2264 grade 2 and alopecia.\n8. Ability to swallow and retain oral medication.\n9. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for 6 months after the last dose of study drugs.\n\nExclusion Criteria:\n1. Patients with a known additional malignancy that is progressing or requires active treatment.\n2. Presence of any genetic alterations in EGFR (excluding T790M mutation), ALK, or ROS1 that are known to confer resistance to AZD9291 and bevacizumab.\n3. History of interstitial lung disease or pneumonitis.\n4. Uncontrolled hypertension despite standard medical management.\n5. History of hemoptysis (\u2265 1/2 teaspoon of bright red blood per episode) within 1 month prior to study entry.\n6. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry, or anticipation of need for a major surgical procedure during the course of the study.\n7. Known hypersensitivity to AZD9291, bevacizumab, or any of their excipients.\n8. Current use of any prohibited medications that are known strong CYP3A4 inducers or inhibitors.\n9. Pregnant or breastfeeding women, or women planning to become pregnant during the study and within 6 months after the final dose of study drugs.\n10. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR mutation\", \"ALK mutation\", \"ROS1 mutation\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Pembrolizumab in Combination with Gemcitabine/Cisplatin in the First-Line Treatment of Patients with Advanced Biliary Tract Cancer with High Microsatellite Instability (MSI-H) or Deficient Mismatch Repair (dMMR)\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of biliary tract cancer (BTC), including cholangiocarcinoma, gallbladder cancer, or ampulla of Vater cancer.\n2. Advanced (unresectable) or metastatic disease.\n3. No prior systemic therapy for advanced disease.\n4. Documented MSI-H or dMMR status in tumor tissue.\n5. Age \u2265 18 years.\n6. ECOG performance status of 0 or 1.\n7. Measurable disease as defined by RECIST 1.1 criteria.\n8. Adequate organ function as defined by study-specific laboratory tests.\n9. Ability to swallow and retain oral medication.\n10. Women of childbearing potential and men must agree to use adequate contraception for the duration of study participation and for 120 days after the last dose of study medication.\n\nExclusion Criteria:\n1. Patients with known brain metastases, unless previously treated and stable without steroid treatment for at least 4 weeks.\n2. History of another malignancy within 2 years prior to study entry, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years.\n4. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n5. Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n6. Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).\n7. Current use of immunosuppressive medication, except for steroids for adrenal failure, inhalers, intranasal steroids, or local steroid injections.\n8. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n9. Pregnant or breastfeeding women, or women planning to become pregnant during the study and within 120 days after the last dose of study medication.\n10. Any other significant medical, social, or psychological condition that, in the opinion of the investigator, may interfere with study participation or compliance.",
        "output": "{\"inclusion_biomarker\": [[\"High Microsatellite Instability\"], [\"Deficient Mismatch Repair\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of AZD9291 (Osimertinib) in Patients with EGFR T790M Mutation-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer, Post Failure of Initial EGFR TKI Therapy\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.\n2. Documented evidence of tumor harboring an EGFR T790M mutation as identified by a validated test.\n3. Disease progression during or after treatment with an approved first-generation or second-generation EGFR TKI.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0-2.\n6. Minimum of one measurable lesion as defined by RECIST 1.1 criteria.\n7. Adequate bone marrow, liver, and renal function.\n8. Ability to swallow and retain oral medication.\n9. Written informed consent prior to any study-specific procedures.\n\nExclusion Criteria:\n1. Prior treatment with a third-generation EGFR TKI.\n2. Presence of EGFR exon 20 insertion mutations or other resistance mutations known to confer resistance to osimertinib.\n3. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids to control CNS symptoms.\n4. History of interstitial lung disease or pneumonitis.\n5. Any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).\n6. Any prior chemotherapy or targeted therapy within 3 weeks prior to starting study treatment.\n7. Major surgery within 4 weeks of starting study treatment.\n8. Pregnant or breastfeeding women.\n9. Any other condition that, in the investigator\u2019s opinion, would make the patient unsuitable for the study or prevent compliance with the protocol.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Nivolumab in Combination with Ipilimumab versus Placebo in Patients with Resectable Biliary Tract Cancer with High Microsatellite Instability (MSI-H) or Deficient Mismatch Repair (dMMR)\n\nInclusion Criteria:\n1. Histologically confirmed resectable biliary tract cancer (including gallbladder cancer, cholangiocarcinoma, and ampulla of Vater cancer).\n2. High microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) status confirmed by a CLIA-certified laboratory.\n3. Age \u2265 18 years.\n4. ECOG performance status 0-1.\n5. Adequate organ function as defined by study-specific laboratory tests.\n6. Ability to provide written informed consent.\n7. No prior systemic therapy for biliary tract cancer.\n8. Must be deemed surgically resectable by a multidisciplinary team.\n\nExclusion Criteria:\n1. Prior treatment with any checkpoint inhibitor or any other immunotherapy.\n2. Presence of metastatic disease.\n3. Known additional malignancy that is progressing or requires active treatment, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.\n4. Active, known, or suspected autoimmune disease.\n5. Use of systemic corticosteroids or other immunosuppressive medications within 7 days prior to the first dose of trial treatment.\n6. History of severe hypersensitivity reaction to any monoclonal antibody.\n7. Pregnant or breastfeeding women.\n8. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n9. Known history of Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C.\n10. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.",
        "output": "{\"inclusion_biomarker\": [[\"High Microsatellite Instability\"], [\"Deficient Mismatch Repair\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label Study Evaluating the Efficacy and Safety of AZD9291 (Osimertinib) in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With T790M Mutation Detected by Liquid Biopsy\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of NSCLC that is locally advanced or metastatic.\n2. Documented evidence of T790M mutation in circulating tumor DNA (ctDNA) from a plasma sample collected at screening.\n3. Progression on or after treatment with an EGFR-TKI.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0-1.\n6. Adequate bone marrow, liver, and renal functions.\n7. At least one measurable lesion as defined by RECIST v1.1.\n8. Ability to provide written informed consent.\n\nExclusion Criteria:\n1. Presence of EGFR exon 20 insertion mutations.\n2. Prior treatment with a third-generation EGFR-TKI.\n3. Known symptomatic brain metastases requiring steroids, or brain metastases that are not stable for > 4 weeks prior to start of study treatment.\n4. History of interstitial lung disease or pneumonitis.\n5. Concurrent use of other anti-cancer therapies.\n6. Uncontrolled systemic disease, including active infection requiring systemic therapy.\n7. Pregnant or breastfeeding women.\n8. Known hypersensitivity to AZD9291 or its excipients.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A Randomized Phase III Study to Compare the Efficacy of Pembrolizumab plus Chemotherapy vs. Chemotherapy Alone in Triple Negative Breast Cancer (TNBC) Patients with High PD-L1 Expression and Germline BRCA Mutation\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of triple-negative breast cancer (TNBC).\n2. Germline BRCA1 or BRCA2 mutation identified.\n3. High PD-L1 expression in tumor cells (CPS \u2265 10) as determined by an FDA-approved test.\n4. No prior systemic therapy for the treatment of metastatic disease.\n5. Age \u2265 18 years.\n6. ECOG performance status of 0 or 1.\n7. Adequate organ function as defined by study-specific laboratory tests.\n8. At least one measurable lesion as defined by RECIST v1.1.\n9. Female patients of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment and agree to use an effective form of contraception.\n\nExclusion Criteria:\n1. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).\n2. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs).\n3. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n4. Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n5. Active CNS metastases and/or carcinomatous meningitis.\n6. Active infection requiring systemic therapy.\n7. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.\n8. Known history of HIV (HIV 1/2 antibodies).\n9. Known history of Hepatitis B (e.g., Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (e.g., HCV RNA [qualitative] is detected).",
        "output": "{\"inclusion_biomarker\": [[\"BRCA1 mutation\", \"BRCA2 mutation\"], [\"PD-L1 expression\"], [\"BRCA mutation (germline)\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label Study Evaluating the Efficacy of AZD9291 (Osimertinib) in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with T790M Mutation Detected by Liquid Biopsy\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.\n2. Documented progression during or after treatment with an EGFR TKI.\n3. Presence of T790M mutation in circulating tumor DNA (ctDNA) detected by a validated liquid biopsy assay.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0-2.\n6. Adequate organ and marrow function.\n7. Patients must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n8. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n\nExclusion Criteria:\n1. Patients with known sensitizing EGFR mutations (e.g., exon 19 deletions or exon 21 L858R mutations) who have not previously been treated with an EGFR TKI.\n2. Presence of EGFR exon 20 insertion mutations.\n3. Prior treatment with AZD9291 (Osimertinib) or other third-generation EGFR inhibitors.\n4. Known symptomatic brain metastases requiring steroids. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.\n5. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n6. History of another primary malignancy except for: malignancy treated with curative intent and with no known active disease \u22655 years before the first dose of study treatment and of low potential risk for recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 19 deletion\", \"EGFR exon 21 L858R\"], [\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC) in Patients Homozygous for the BRCA1/2 Gene\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.\n2. Metastatic disease documented by positive bone scan or metastatic lesions on CT/MRI.\n3. Progression of disease on androgen deprivation therapy or post bilateral orchiectomy (castration-resistant prostate cancer).\n4. Homozygous for BRCA1/2 mutations as determined by a validated genomic or next-generation sequencing assay.\n5. Prior treatment with at least one novel hormonal agent (e.g., enzalutamide, apalutamide).\n6. ECOG performance status of 0-1.\n7. Adequate organ function.\n8. Age \u2265 18 years.\n9. Ability to swallow and retain oral medication.\n\nExclusion Criteria:\n1. Prior treatment with chemotherapy for mCRPC.\n2. Prior treatment with PARP inhibitors or known hypersensitivity to any of the components of niraparib or abiraterone acetate.\n3. Active brain metastases or leptomeningeal disease.\n4. Concurrent use of other anti-cancer treatments.\n5. Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n6. Uncontrolled hypertension, history of myocardial infarction, unstable angina, stroke, or heart failure within the previous 6 months.\n7. Significant gastrointestinal disorders that may interfere with the absorption of the study drug.\n8. Known history of HIV, Hepatitis B, or Hepatitis C.",
        "output": "{\"inclusion_biomarker\": [[\"BRCA1 mutation\"], [\"BRCA2 mutation\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of AZD9291 in Combination with Bevacizumab in Patients with EGFR-mutant Non-Small Cell Lung Cancer (NSCLC) After Progression on a Previous EGFR-TKI\n;\n;\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC with an activating mutation in the EGFR gene (exon 19 deletion or exon 21 L858R substitution mutations).\n2. Patients must have progressed on a first- or second-generation EGFR-TKI and have not received more than one line of chemotherapy for metastatic disease.\n3. Age \u2265 18 years.\n4. ECOG performance status 0-1.\n5. Measurable disease according to RECIST v1.1 criteria.\n6. Adequate organ and marrow function as defined by study-specific laboratory tests.\n7. Patients must provide a fresh or archival tumor tissue sample for biomarker analysis, including T790M mutation status.\n8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the last dose of study drug.\nExclusion Criteria:\n1. Patients with known T790M-negative tumors.\n2. Presence of any other significant genetic alterations in EGFR (e.g., exon 20 insertions) that are known to confer resistance to EGFR-TKIs.\n3. Prior treatment with third-generation EGFR-TKIs (e.g., osimertinib) or anti-VEGF therapy (e.g., bevacizumab).\n4. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active interstitial lung disease.\n5. Active brain metastases or leptomeningeal metastases. Patients with previously treated brain metastases that are radiologically stable for at least 4 weeks after treatment and off steroids for at least 2 weeks before starting study treatment are eligible.\n6. Uncontrolled hypertension (BP > 150/100 mmHg despite medical therapy).\n7. Significant cardiovascular disease such as recent myocardial infarction (within 3 months), unstable angina, congestive heart failure (New York Heart Association > Class II), or serious cardiac arrhythmia requiring medication.\n8. Known history of HIV infection, hepatitis B or C infection.\n9. Any other malignancies within the last 5 years except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.\n10. Pregnant or breastfeeding women.\n11. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR exon 19 deletion\", \"EGFR exon 21 L858R\"], [\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR T790M\"], [\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Pembrolizumab in Combination with Chemotherapy versus Chemotherapy Alone in Patients with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma with a PD-L1 Combined Positive Score (CPS) \u226510\n;\n;\nInclusion Criteria:\n1. Histologically confirmed diagnosis of unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma.\n2. PD-L1 CPS \u226510 as determined by an FDA-approved test.\n3. No prior systemic treatment for advanced disease.\n4. Age \u226518 years.\n5. ECOG performance status 0 or 1.\n6. Measurable disease as defined by RECIST v1.1.\n7. Adequate organ function as defined by study-specific laboratory tests.\n8. Ability to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Archival tissue is acceptable if a new biopsy cannot be obtained.\n9. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the last dose of study drug.\nExclusion Criteria:\n1. Known HER2-positive tumors.\n2. Patients with active autoimmune disease that has required systemic treatment in the past 2 years.\n3. Prior treatment with any PD-1, PD-L1, or PD-L2 antagonist, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).\n4. Active brain metastases or leptomeningeal metastases. Patients with previously treated brain metastases that are radiologically stable for at least 4 weeks after treatment and off steroids for at least 2 weeks before starting study treatment are eligible.\n5. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n6. Uncontrolled or significant cardiovascular disease, including recent myocardial infarction (within 6 months), congestive heart failure (New York Heart Association Class III or IV), and uncontrolled hypertension.\n7. Known history of HIV, hepatitis B, or hepatitis C infection.\n8. Any other malignancies within the last 3 years except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.\n9. Pregnant or breastfeeding women.\n10. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",
        "output": "{\"inclusion_biomarker\": [[\"PD-L1 CPS\"]], \"exclusion_biomarker\": [[\"HER2 positive\"]]}"
    },
    {
        "input": " A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy of AZD9291 in Patients with T790M Mutation-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer, Previously Treated with an EGFR-TKI\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.\n2. Documented T790M mutation in the EGFR gene as detected by a validated test.\n3. Disease progression during or after treatment with an EGFR tyrosine kinase inhibitor (TKI).\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ and marrow function.\n7. Patients must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n8. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n\nExclusion Criteria:\n1. Presence of EGFR sensitizing mutations (exon 19 deletions or exon 21 L858R mutations) without T790M mutation.\n2. Prior treatment with AZD9291 or other third-generation EGFR inhibitors.\n3. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids to control their CNS disease.\n4. History of interstitial lung disease or pneumonitis.\n5. Active infections requiring systemic therapy.\n6. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.\n7. Other malignancies within the last 5 years except for cancers with a negligible risk of metastasis or death.\n8. Pregnant or breastfeeding women.\n9. Patients who have had another anti-cancer therapy within 2 weeks prior to starting study treatment.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 19 deletion\"], [\"EGFR exon 21 L858R\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Study of BGB-290 in Combination with Temozolomide versus Temozolomide Alone in Patients with MGMT-Unmethylated, Newly Diagnosed Glioblastoma\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of glioblastoma (GBM) with unmethylated MGMT promoter.\n2. Patients must be newly diagnosed and planned for treatment with temozolomide.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0-2.\n5. Adequate bone marrow, liver, and renal function.\n6. Patients must have measurable disease based on RANO criteria.\n7. Ability to understand and willingness to sign a written informed consent document.\n8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the completion of study treatment.\n\nExclusion Criteria:\n1. Prior treatment for glioblastoma other than surgery.\n2. Presence of IDH1 or IDH2 mutations.\n3. Known hypersensitivity to BGB-290, temozolomide, or their excipients.\n4. Participation in another clinical study with an investigational product during the last 4 weeks.\n5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n6. Pregnant or breastfeeding women.\n7. Known HIV-positive patients on combination antiretroviral therapy.\n8. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",
        "output": "{\"inclusion_biomarker\": [[\"MGMT unmethylated promoter\"]], \"exclusion_biomarker\": [[\"IDH1 mutation\"], [\"IDH2 mutation\"]]}"
    },
    {
        "input": " A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of AZD4547 in Patients with Advanced Solid Tumors Harboring FGFR1-3 Genetic Alterations\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of advanced solid tumors with FGFR1, FGFR2, or FGFR3 genetic alterations identified through a validated genomic assay.\n2. Age \u2265 18 years.\n3. ECOG performance status of 0 or 1.\n4. Measurable disease according to RECIST v1.1.\n5. Adequate organ and marrow function as defined by study-specific laboratory criteria.\n6. Patients must have progressed on or be intolerant to standard therapy known to confer clinical benefit, or there must be no acceptable standard treatment options.\n7. Ability to swallow and retain oral medication.\n8. Patients must provide a fresh tumor biopsy for biomarker analysis unless medically contraindicated. In cases where a fresh biopsy cannot be obtained, archival tissue may be acceptable subject to approval by the study medical monitor.\n9. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the completion of study treatment.\n\nExclusion Criteria:\n1. Presence of FGFR genetic alterations known to confer resistance to AZD4547 based on preclinical or clinical studies.\n2. Prior treatment with any FGFR inhibitors.\n3. Known brain metastases that are symptomatic or require treatment. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment), and without any requirement for steroids or anticonvulsants.\n4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n5. Pregnant or breastfeeding women.\n6. Known history of HIV (HIV 1/2 antibodies), Hepatitis B (HBsAg positive or HBcAb positive), or Hepatitis C (HCV RNA is detected).\n7. Any other condition that, in the investigator\u2019s opinion, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"FGFR1 alteration\"], [\"FGFR2 alteration\"], [\"FGFR3 alteration\"]], \"exclusion_biomarker\": [[\"FGFR alteration\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of BKM120 Plus Fulvestrant in Postmenopausal Women with Hormone Receptor-Positive HER2-Negative PIK3CA-Mutant Advanced or Metastatic Breast Cancer\n\nInclusion Criteria:\n1. Postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.\n2. Documented PIK3CA mutation in tumor tissue by a validated genomic or molecular assay.\n3. Progression on or after prior endocrine therapy.\n4. At least one measurable lesion as defined by RECIST 1.1.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ and marrow function.\n7. Patients must agree to provide tumor tissue from a biopsy for confirmation of PIK3CA mutation status if recent tissue is not available.\n8. Women must agree to use effective contraception during the study and for 3 months after the last dose of study medication.\n\nExclusion Criteria:\n1. Prior treatment with PI3K inhibitors.\n2. Known hypersensitivity to BKM120 or fulvestrant or to any of their excipients.\n3. Patients with brain metastases that are symptomatic or require treatment. Patients with treated brain metastases stable for at least 4 weeks without steroids are eligible.\n4. History of another malignancy within the last 3 years except for tumors with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer.\n5. Uncontrolled electrolyte disorders that can compound the effects of a PI3K inhibitor, such as hypocalcemia, hypokalemia, or hypomagnesemia.\n6. Significant cardiac disease or history of cardiac dysfunction.\n7. Known HIV or active hepatitis B or C infection.\n8. Any other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures or interfere with the evaluation of study results.",
        "output": "{\"inclusion_biomarker\": [[\"HER2 negative\", \"PIK3CA mutation\", \"Hormone receptor positive\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Randomized, Double-Blind Study to Evaluate the Efficacy of AZD9291 Combined with Bevacizumab versus AZD9291 Alone in T790M-Positive EGFR Mutant Non-Small Cell Lung Cancer (NSCLC) After Failure of First-Line EGFR TKI Therapy.\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC that harbors an EGFR T790M mutation detected by a plasma or tissue-based assay.\n2. Disease progression during or after treatment with a first-line EGFR TKI.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. Measurable disease according to RECIST v1.1 criteria.\n6. Adequate organ and marrow function.\n7. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.\n8. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n1. Prior treatment with any systemic therapy for NSCLC other than an EGFR TKI.\n2. Presence of EGFR exon 20 insertion mutations or other driver mutations such as ALK rearrangements.\n3. Known symptomatic central nervous system (CNS) metastases requiring steroids. Patients with previously treated CNS metastases may participate provided they are stable without evidence of progression for at least 4 weeks.\n4. Significant cardiovascular disease, such as New York Heart Association class III or IV congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.\n5. History of another primary malignancy within 5 years prior to enrollment, with the exceptions of non-melanoma skin cancer and cervical carcinoma in situ.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.\n7. Pregnant or breastfeeding women.\n8. Known hypersensitivity to AZD9291, bevacizumab, or any of their excipients.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"], [\"ALK rearrangements\"]]}"
    },
    {
        "input": " A Phase III, Multicenter, Randomized Study Comparing the Efficacy of Venetoclax Plus Fulvestrant versus Fulvestrant Alone in Patients with ER+, HER2-, PIK3CA Mutant Metastatic Breast Cancer Who Have Progressed on or After Aromatase Inhibitor Therapy.\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of estrogen receptor-positive (ER+), HER2-negative metastatic breast cancer.\n2. Documented PIK3CA mutation in tumor tissue or circulating tumor DNA.\n3. Progression on or after an aromatase inhibitor in the metastatic setting.\n4. Postmenopausal women or men aged \u2265 18 years.\n5. ECOG performance status of 0-2.\n6. Measurable disease or non-measurable but evaluable disease according to RECIST v1.1.\n7. Adequate bone marrow, liver, and renal function.\n8. Ability to swallow oral medications.\n9. For women of childbearing potential: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating eggs during the study and for at least 90 days after the last dose of study treatment.\n\nExclusion Criteria:\n1. Prior treatment with any CDK4/6 inhibitor, mTOR inhibitor, or PI3K inhibitor.\n2. Known hypersensitivity to venetoclax, fulvestrant, or any of their excipients.\n3. Active brain metastases or leptomeningeal disease. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.\n4. History of another malignancy within 5 years prior to enrollment, except for malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma.\n5. Uncontrolled or significant cardiovascular disease, including recent myocardial infarction, congestive heart failure, unstable angina, or significant arrhythmias.\n6. Known HIV infection, active hepatitis B or C infection.\n7. Pregnant or breastfeeding women.\n8. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.",
        "output": "{\"inclusion_biomarker\": [[\"ER positive\"], [\"HER2 negative\"], [\"PIK3CA mutation\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label Study Evaluating the Efficacy of AZD6738 in Combination with Olaparib in Patients with Triple-Negative Breast Cancer (TNBC) Harboring ATM Mutations\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of triple-negative breast cancer (TNBC) that is metastatic or locally advanced and unresectable.\n2. Documented ATM mutation in the tumor tissue by a CLIA-certified (in the US) or equivalent (outside the US) laboratory.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. Measurable disease as defined by RECIST v1.1.\n6. Prior treatment with no more than three lines of chemotherapy for metastatic disease. Prior treatment with a PARP inhibitor is allowed.\n7. Adequate bone marrow, liver, and renal function.\n8. Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during the study and for 6 months after the last dose of study drug.\n9. Ability to swallow and retain oral medication.\n\nExclusion Criteria:\n1. Prior treatment with an ATM inhibitor.\n2. Presence of BRCA1 or BRCA2 mutations.\n3. Known hypersensitivity to AZD6738, olaparib, or their excipients.\n4. Active or untreated central nervous system (CNS) metastases. Patients with treated CNS metastases that are stable for at least 4 weeks after therapy and off steroids are eligible.\n5. History of another malignancy within the last 3 years, except for adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or localized prostate cancer with a current PSA of <0.1 ng/mL.\n6. Concurrent use of other anticancer therapy.\n7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.\n8. Pregnant or breastfeeding women.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"ATM mutation\"]], \"exclusion_biomarker\": [[\"BRCA1 mutation\"], [\"BRCA2 mutation\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Study of BGB-290 (Pamiparib) in Patients with Previously Treated, Advanced Non-Small Cell Lung Cancer (NSCLC) with Homologous Recombination Repair (HRR) Gene Mutations\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.\n2. Documented mutation in at least one of the following HRR genes: BRCA1, BRCA2, ATM, RAD51, PALB2, or CHEK2, determined by a certified laboratory.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. Progression after treatment with at least one platinum-based chemotherapy regimen and one other systemic therapy. Prior treatment with a PARP inhibitor is not allowed.\n6. At least one measurable lesion as defined by RECIST v1.1.\n7. Adequate organ and marrow function.\n8. Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during the study and for 6 months after the last dose of study drug.\n9. Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n1. Known mutations in EGFR, ALK, or ROS1 for which targeted therapy is available.\n2. Treatment with more than three lines of chemotherapy for advanced disease.\n3. Prior treatment with a PARP inhibitor.\n4. Active brain metastases or leptomeningeal metastases. Patients with previously treated brain metastases that are stable for at least 4 weeks after treatment and off steroids are eligible.\n5. History of another primary malignancy that is currently clinically significant or requires active intervention.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n7. Pregnant or breastfeeding women.\n8. Concurrent use of other investigational drugs.",
        "output": "{\"inclusion_biomarker\": [[\"BRCA1 mutation\", \"BRCA2 mutation\", \"ATM mutation\", \"RAD51 mutation\", \"PALB2 mutation\", \"CHEK2 mutation\"]], \"exclusion_biomarker\": [[\"EGFR mutation\"], [\"ALK mutation\"], [\"ROS1 mutation\"]]}"
    },
    {
        "input": " A Phase II, Open-Label Study Evaluating the Efficacy and Safety of AZD6738 in Combination with Olaparib in Patients with Advanced Solid Tumors Harboring Homologous Recombination Repair (HRR) Gene Mutations\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed solid tumors with advanced or metastatic disease.\n2. Documented genetic aberrations in HRR genes (e.g., BRCA1, BRCA2, ATM, PALB2) through a validated genomic test.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0-2.\n5. Measurable disease according to RECIST v1.1 criteria.\n6. Prior treatment with at least one line of systemic therapy for advanced disease or considered unsuitable for standard treatment.\n7. Adequate bone marrow, liver, and renal function.\n8. Willingness to undergo blood sampling for pharmacokinetic (PK) analysis and biomarker studies.\n9. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use effective contraception during the study and for 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n1. Known mutations in HRR genes that are considered benign or likely benign.\n2. Prior treatment with a PARP inhibitor or ATR inhibitor.\n3. Active brain metastases or leptomeningeal disease. Patients with previously treated brain metastases that are stable for at least 4 weeks following treatment and without requirement of steroid therapy are eligible.\n4. History of another malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n5. Significant cardiovascular disease, including heart failure meeting New York Heart Association Class III or IV, uncontrolled hypertension, or history of myocardial infarction within 6 months prior to starting study treatment.\n6. Known hypersensitivity to any of the study drugs or their excipients.\n7. Concurrent use of strong CYP3A inhibitors or inducers.\n8. Pregnant or breastfeeding women.\n9. Any other medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"BRCA1 aberration\"], [\"BRCA2 aberration\"], [\"ATM aberration\"], [\"PALB2 aberration\"]], \"exclusion_biomarker\": [[\"HRR benign mutation\"], [\"HRR likely benign mutation\"]]}"
    },
    {
        "input": " A Randomized Phase III Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination with Chemotherapy versus Chemotherapy Alone in Patients with Advanced Gastroesophageal Cancer with PD-L1 Positive Expression and Microsatellite Instability-High (MSI-H) or Epstein-Barr Virus (EBV) Positive Biomarkers\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic gastroesophageal cancer (including gastric, esophagogastric junction, and esophageal cancers).\n2. PD-L1 positive expression as determined by an FDA-approved test.\n3. MSI-H or EBV positive status as determined by validated tests.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0-1.\n6. Measurable disease according to RECIST v1.1 criteria.\n7. Adequate organ function as defined by study-specific laboratory tests.\n8. Prior treatment with no more than one line of systemic therapy for advanced disease or considered unsuitable for certain therapies.\n9. Ability and willingness to provide written informed consent and comply with the protocol.\n\nExclusion Criteria:\n1. Known hypersensitivity to pembrolizumab, any of its excipients, or drugs of similar chemical classes.\n2. Prior therapy with an immune checkpoint inhibitor.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years.\n4. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n5. Active infection requiring systemic therapy.\n6. Presence of any other cancer from which the patient has been disease-free for less than 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n8. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.\n9. Concurrent use of other investigational drugs.\n10. Any medical condition that, in the investigator\u2019s opinion, would make the patient unsuitable for the study or interfere with the patient\u2019s participation.",
        "output": "{\"inclusion_biomarker\": [[\"PD-L1 expression\"], [\"Microsatellite Instability-High\"], [\"EBV positive\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label Study Evaluating the Efficacy of AZD9291 (Osimertinib) in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with EGFR T790M Mutation and Specific Co-occurring Genetic Alterations.\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of stage IIIB/IV NSCLC.\n2. Documented evidence of EGFR T790M mutation.\n3. Patients must have progressed on or after EGFR TKI therapy.\n4. Presence of one or more of the following co-occurring genetic alterations: MET amplification, HER2 amplification, or PIK3CA mutations.\n5. Age \u2265 18 years.\n6. ECOG performance status of 0 or 1.\n7. At least one measurable lesion as defined by RECIST 1.1.\n8. Adequate organ and marrow function.\n9. Ability to swallow and retain oral medication.\n10. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days after completion of osimertinib administration.\n\nExclusion Criteria:\n1. Previous treatment with a third-generation EGFR TKI.\n2. Presence of EGFR exon 20 insertion mutations.\n3. Known symptomatic brain metastases requiring steroids. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.\n4. History of interstitial lung disease or pneumonitis.\n5. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, unstable angina pectoris, congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements.\n6. Pregnant or breastfeeding women.\n7. Known hypersensitivity to AZD9291 or any excipient in the formulation.\n8. Participation in another clinical study with an investigational product during the last 30 days before enrollment.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"], [\"MET amplification\", \"HER2 amplification\", \"PIK3CA mutation\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A Randomized Phase III Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination with Chemotherapy versus Chemotherapy Alone in Patients with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma with a High Combined Positive Score (CPS) for PD-L1 and Specific DNA Mismatch Repair (dMMR) or Microsatellite Instability-High (MSI-H) Biomarkers.\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of gastric or GEJ adenocarcinoma, unresectable locally advanced or metastatic.\n2. High CPS for PD-L1 (CPS \u226510) as determined by a validated assay.\n3. Documented dMMR or MSI-H status by a validated assay.\n4. No prior therapy for advanced disease. Patients may have received neoadjuvant or adjuvant therapy provided it was completed more than 6 months prior to randomization.\n5. Age \u2265 18 years.\n6. ECOG performance status of 0 or 1.\n7. Measurable disease according to RECIST 1.1.\n8. Adequate organ function.\n9. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.\n10. Male and female patients of childbearing potential must agree to use an effective method of contraception during the treatment and for at least 6 months after the last dose of study drug.\n\nExclusion Criteria:\n1. Known additional malignancy that is progressing or requires active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy.\n2. Active autoimmune disease that has required systemic treatment in the past 2 years.\n3. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n4. Active infection requiring systemic therapy.\n5. Known history of Human Immunodeficiency Virus (HIV).\n6. Known history of Hepatitis B or C.\n7. Current or prior use of immunosuppressive medication within 14 days before the first dose of trial treatment, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses.\n8. Live vaccine within 30 days prior to the first dose of trial treatment.\n9. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n10. Pregnant or breastfeeding women.\n11. Known hypersensitivity to pembrolizumab or any of its excipients or any component of the chemotherapy regimen.",
        "output": "{\"inclusion_biomarker\": [[\"PD-L1 positive\"], [\"DNA Mismatch Repair\"], [\"Microsatellite Instability-High\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label Study Evaluating the Efficacy of AZD9291 (Osimertinib) in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with EGFR T790M Mutation and MET Amplification\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC.\n2. Patients must have progressed on an FDA-approved EGFR TKI.\n3. Presence of EGFR T790M mutation detected in a tumor specimen via a CLIA-certified laboratory.\n4. MET amplification detected in a tumor specimen via a CLIA-certified laboratory.\n5. Age \u2265 18 years.\n6. ECOG performance status of 0-1.\n7. Adequate organ and marrow function as defined by study-specific laboratory tests.\n8. Ability to swallow and retain oral medication.\n9. Written informed consent and HIPAA authorization for release of personal health information.\n10. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria:\n1. Patients with known EGFR exon 20 insertions or other resistance mutations in EGFR.\n2. Prior treatment with AZD9291 (Osimertinib) or other MET inhibitors.\n3. Presence of a known mutation in KRAS, BRAF, or HER2 that is believed to drive the cancer.\n4. Active brain metastases or leptomeningeal metastases - patients with previously treated brain metastases, stable for \u2265 4 weeks without steroid treatment, are eligible.\n5. History of interstitial lung disease or pneumonitis.\n6. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n7. Pregnant or breastfeeding women.\n8. Known HIV-positive individuals on combination antiretroviral therapy.\n9. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"], [\"MET amplification\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"], [\"EGFR resistance mutation\"], [\"KRAS mutation\"], [\"BRAF mutation\"], [\"HER2 mutation\"]]}"
    },
    {
        "input": " A Randomized Phase III Study of Pembrolizumab versus Placebo in Patients with Hepatocellular Carcinoma and a Positive Biomarker Signature\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of hepatocellular carcinoma (HCC).\n2. Presence of a positive biomarker signature defined as PD-L1 expression and/or specific genomic alterations (e.g., CTNNB1 mutation, TP53 mutation).\n3. Child-Pugh Class A liver function.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0-1.\n6. Measurable disease by RECIST 1.1 criteria.\n7. Adequate organ function as defined by study-specific laboratory tests.\n8. Ability to understand and willingness to sign a written informed consent document.\n9. For women of childbearing potential, agreement to use two forms of contraception during the study and for 120 days after the last dose of study medication.\n\nExclusion Criteria:\n1. Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) & T1 (tumor invades subepithelial connective tissue)] or any cancer curatively treated > 3 years prior to study entry.\n2. Prior systemic treatment for HCC.\n3. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n4. Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.\n5. Evidence of bleeding diathesis or significant coagulopathy.\n6. History of a second malignancy unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.\n7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n8. Pregnant or breastfeeding women.\n9. Known history of HIV (HIV 1/2 antibodies).\n10. Known history of Hepatitis B (HBsAg positive) or Hepatitis C (HCV RNA [qualitative] is detected).\n11. Patients who have received a live vaccine within 30 days prior to the first dose of trial treatment.",
        "output": "{\"inclusion_biomarker\": [[\"PD-L1 expression\"], [\"CTNNB1 mutation\"], [\"TP53 mutation\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of AZD9291 (Osimertinib) in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR T790M Mutation Detected by a Blood-Based Assay\n;\n;\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.\n2. Documented evidence of tumor harboring an EGFR T790M mutation as identified by a validated blood-based assay.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. At least one measurable lesion as defined by RECIST 1.1.\n6. Previous treatment with an EGFR tyrosine kinase inhibitor (TKI).\n7. Adequate organ and marrow function.\n8. Non-pregnant and non-nursing. Participants must agree to use effective contraception during the study and for 12 weeks after the last dose of study drug.\nExclusion Criteria:\n1. Known sensitizing mutations in EGFR (exon 19 deletions or exon 21 L858R mutations) without T790M mutation.\n2. Treatment with more than one line of chemotherapy for advanced NSCLC.\n3. Prior treatment with an EGFR T790M-targeting agent.\n4. Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the previous 2 weeks.\n5. Any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or uncontrolled hypertension.\n6. History of another primary malignancy within the last 3 years, except for malignancies with a negligible risk of metastasis or death.\n7. Known hypersensitivity to AZD9291 or any excipient of the product.\n8. Participation in another clinical study with an investigational product during the last 4 weeks.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 19 deletion\"], [\"EGFR exon 21 L858R\"], [\"EGFR T790M\"]]}"
    },
    {
        "input": " A Randomized Phase III Study of Pembrolizumab versus Placebo in Patients with Hepatocellular Carcinoma with Complete Radiological Response Post Surgery or Ablation and Positive for PDL1 Expression\n;\n;\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of Hepatocellular Carcinoma (HCC).\n2. Complete radiological response achieved post surgery or ablation as per RECIST 1.1 criteria.\n3. Positive for PDL1 expression in tumor tissue as determined by an FDA-approved test.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ function.\n7. Participants with Child-Pugh A liver function.\n8. Ability to provide tissue from an archival tissue sample or willing to undergo a biopsy.\n9. Non-pregnant and non-nursing. Participants must agree to use effective contraception during the study and for 6 months after the last dose of study drug.\nExclusion Criteria:\n1. Prior systemic therapy for HCC including chemotherapy, targeted therapy, or immunotherapy.\n2. Active autoimmune disease that has required systemic treatment in the past 2 years.\n3. History of a second malignancy unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n4. Presence of untreated or symptomatic CNS metastases.\n5. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n6. Known history of HIV, Hepatitis B (except for those with hepatitis B surface antigen [HBsAg] cleared), or Hepatitis C virus infection.\n7. Any condition that requires concurrent use of systemic corticosteroids (greater than 10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of trial treatment start.\n8. Known hypersensitivity to pembrolizumab or any of its excipients.\n9. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",
        "output": "{\"inclusion_biomarker\": [[\"PDL1 expression\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label Study to Evaluate the Efficacy and Safety of AZD9291 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with EGFR T790M Mutation After Failure of First-Line EGFR-TKI Therapy\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC.\n2. Documented evidence of tumor harboring an EGFR T790M mutation as identified by a validated test.\n3. Disease progression during or after treatment with a first-line EGFR-TKI (e.g., erlotinib, gefitinib, or afatinib).\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. At least one measurable lesion as defined by RECIST 1.1.\n7. Adequate organ and marrow function.\n8. Ability to swallow and retain oral medication.\n9. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria:\n1. Prior treatment with any drug targeting EGFR T790M mutation.\n2. Presence of any other known resistance mutations in the EGFR gene (e.g., C797S).\n3. Known symptomatic brain metastases requiring steroids, or brain metastases that have not been stable for at least 4 weeks after treatment and have not been imaged within 2 weeks prior to study entry.\n4. History of interstitial lung disease or pneumonitis.\n5. Active infection requiring systemic therapy.\n6. Uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, or serious cardiac arrhythmia requiring medication.\n7. History of another malignancy within 2 years prior to study entry, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n8. Pregnant or breastfeeding women.\n9. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n10. Treatment with any other investigational agents or participation in another clinical trial with therapeutic intent within 4 weeks prior to study entry.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR T790M\"], [\"EGFR C797S\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Axitinib versus Axitinib Alone in Patients with Advanced Renal Cell Carcinoma (RCC) with PD-L1 Positive Tumors\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of advanced RCC.\n2. PD-L1 positive tumor expression as determined by an FDA-approved test.\n3. Clear cell RCC component.\n4. No prior systemic therapy for advanced RCC.\n5. ECOG performance status of 0 or 1.\n6. Measurable disease according to RECIST 1.1.\n7. Adequate organ function.\n8. Male and female subjects of childbearing potential must agree to use an adequate method of contraception for the duration of the study and for 120 days after the last dose of study medication.\n\nExclusion Criteria:\n1. Presence of sarcomatoid features in the tumor.\n2. Known additional malignancy that is progressing or requires active treatment, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years.\n4. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n5. Active brain metastases or leptomeningeal metastases.\n6. An active infection requiring systemic therapy.\n7. A history of a severe hypersensitivity reaction to pembrolizumab and/or axitinib or any of their excipients.\n8. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n9. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n10. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.",
        "output": "{\"inclusion_biomarker\": [[\"PD-L1 expression\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label, Randomized Study to Assess the Efficacy and Safety of AZD9291 versus Standard of Care EGFR-TKI as First-Line Treatment in Patients with EGFRm Advanced Non-Small Cell Lung Cancer with a Focus on CNS Efficacy\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC).\n2. Documented evidence of an activating mutation in the EGFR gene (exon 19 deletions or exon 21 L858R substitution mutations).\n3. No prior treatment for advanced or metastatic disease; patients may have received prior adjuvant therapy if completed more than 6 months before the diagnosis of advanced disease.\n4. Measurable disease according to RECIST v1.1 criteria.\n5. ECOG performance status of 0 or 1.\n6. Age \u2265 18 years.\n7. Adequate organ and marrow function.\n8. Willingness to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.\n9. Patients with stable, treated brain metastases are eligible provided they are asymptomatic and do not require steroids for at least 4 weeks before start of study treatment.\n\nExclusion Criteria:\n1. Evidence of T790M EGFR mutation.\n2. Presence of any other significant genetic alterations in the EGFR gene that are known to confer resistance to EGFR-TKI therapy.\n3. Prior treatment with any EGFR-TKI or other systemic treatment for advanced NSCLC.\n4. Spinal cord compression unless considered to be stable for > 4 weeks after definitive therapy.\n5. History of interstitial lung disease or pneumonitis.\n6. Active infections or serious underlying medical conditions that would impair the ability of the patient to receive study treatment.\n7. Pregnant or breastfeeding women.\n8. Known hypersensitivity to AZD9291 or any of its excipients.\n9. Concurrent enrollment in another clinical study involving an investigational product.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR exon 19 deletion\"], [\"EGFR exon 21 L858R\"]], \"exclusion_biomarker\": [[\"EGFR T790M\"]]}"
    },
    {
        "input": " A Phase III, Double-Blind, Placebo-Controlled Study of Pembrolizumab in Combination with Chemotherapy in Frontline Metastatic Squamous Non-Small Cell Lung Cancer Patients with High PD-L1 Expression and No EGFR or ALK Genomic Tumor Aberrations\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of squamous NSCLC that is metastatic or unresectable.\n2. PD-L1 expression \u226550% as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.\n3. No prior systemic treatment for metastatic NSCLC.\n4. At least one measurable lesion as defined by RECIST v1.1.\n5. ECOG performance status of 0 or 1.\n6. Age \u2265 18 years.\n7. Adequate organ function.\n8. Willingness to provide tissue from a newly obtained biopsy of a tumor lesion.\n9. Patients with treated brain metastases are eligible if they are stable (without evidence of progression by imaging for at least four weeks after the final dose of radiation and no evidence of new or enlarging brain metastases) and off steroids.\n\nExclusion Criteria:\n1. Presence of EGFR mutations or ALK translocations.\n2. Prior chemotherapy or targeted small molecule therapy for metastatic NSCLC.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years.\n4. A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.\n5. A history of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n6. Active infection requiring systemic therapy.\n7. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n8. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n9. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).\n10. Known hypersensitivity to pembrolizumab or any of its excipients.",
        "output": "{\"inclusion_biomarker\": [[\"PD-L1 expression\"]], \"exclusion_biomarker\": [[\"EGFR mutation\"], [\"ALK translocation\"]]}"
    },
    {
        "input": " A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy of ZX008 in Combination with Letrozole in Patients with ER-positive, HER2-negative Advanced Breast Cancer with ESR1 Mutation\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer.\n2. Documented ESR1 mutation detected in circulating tumor DNA (ctDNA) or in a tumor biopsy.\n3. Progression on or after at least one line of endocrine therapy for advanced disease.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. Measurable disease according to RECIST v1.1 criteria.\n7. Adequate organ function as evidenced by laboratory values.\n8. Ability to understand and willingness to sign a written informed consent document.\n9. Women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria:\n1. Prior treatment with more than three lines of chemotherapy for advanced/metastatic breast cancer.\n2. Known hypersensitivity to ZX008, letrozole, or any of their excipients.\n3. Presence of other active cancers, or history of treatment for invasive cancer within the last 5 years. Patients with stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible.\n4. CNS metastases that are symptomatic or require treatment; patients with previously treated CNS metastases that are asymptomatic and stable for at least 4 weeks are eligible.\n5. Concurrent use of other investigational drugs or participation in another clinical trial with therapeutic intent.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n7. Pregnant or breastfeeding women.\n8. Known HIV-positive individuals on combination antiretroviral therapy.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"ER positive\", \"HER2 negative\", \"ESR1 mutation\"]], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Bemcentinib in Combination with Docetaxel in Patients with MET-Amplified Non-Squamous Non-Small Cell Lung Cancer\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).\n2. Documented MET amplification in tumor tissue or plasma.\n3. Progression after platinum-based chemotherapy.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. At least one measurable lesion as defined by RECIST v1.1.\n7. Adequate organ and marrow function.\n8. Ability to swallow and retain oral medication.\n9. Signed informed consent form.\n10. For women of childbearing potential, agreement to use two forms of effective contraception from the time of signing the informed consent form through 120 days after the last dose of study drug.\n\nExclusion Criteria:\n1. Prior treatment with MET inhibitors.\n2. Presence of known EGFR mutations or ALK rearrangements.\n3. Active brain metastases or leptomeningeal metastases. Patients with previously treated brain metastases that are asymptomatic and stable for at least 4 weeks are eligible.\n4. History of another malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.\n5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n6. Pregnant or breastfeeding women.\n7. Known hypersensitivity to bemcentinib, docetaxel, or any of their excipients.\n8. Participation in another clinical study with an investigational product during the last 4 weeks.\n9. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",
        "output": "{\"inclusion_biomarker\": [[\"MET amplification\"]], \"exclusion_biomarker\": [[\"EGFR mutation\"], [\"ALK rearrangement\"]]}"
    },
    {
        "input": " A Phase II, Open-Label Study Assessing the Efficacy of Novel Agent ZYB-258 in Combination with Pembrolizumab in Patients with Advanced Melanoma Harboring BRAF V600 Mutations\n\nInclusion Criteria:\n1. Histologically confirmed diagnosis of unresectable Stage III or IV melanoma.\n2. Presence of a BRAF V600 mutation in the tumor tissue as confirmed by a CLIA-certified laboratory.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. Measurable disease according to RECIST 1.1 criteria.\n6. Prior treatment with, and progression on, at least one line of systemic therapy for advanced disease (including BRAF and/or MEK inhibitors if BRAF V600 mutant).\n7. Adequate organ and marrow function as defined by laboratory values.\n8. Ability to understand and willingness to sign a written informed consent document.\n9. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria:\n1. Presence of any other BRAF mutations apart from V600.\n2. Active brain metastases or leptomeningeal metastases. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.\n3. History of another malignancy within the last 3 years, except for malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or localized prostate cancer with Gleason score \u2264 6 and PSA \u2264 10.\n4. Any prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).\n5. Known history of, or any evidence of, interstitial lung disease or pneumonitis.\n6. Active autoimmune disease that has required systemic treatment in past 2 years.\n7. Uncontrolled adrenal insufficiency.\n8. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n9. Pregnant or breastfeeding women.\n10. Known hypersensitivity to ZYB-258 or pembrolizumab or any of their excipients.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"BRAF V600\"]], \"exclusion_biomarker\": [[\"BRAF mutation\"]]}"
    },
    {
        "input": " A Randomized Phase III Study of TKI-3212 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with MET Exon 14 Skipping Mutations\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IV according to the AJCC 8th edition.\n2. Documented MET exon 14 skipping mutation in tumor tissue or plasma by an FDA-approved test.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. Previously treated with one or two lines of systemic therapy for advanced/metastatic disease, but not previously treated with a MET inhibitor.\n6. At least one measurable lesion as defined by RECIST 1.1.\n7. Adequate organ function as defined by specific laboratory tests.\n8. Ability to swallow and retain oral medication.\n9. Willingness to use adequate contraception for the duration of study participation and for 90 days after the last dose of study medication.\n\nExclusion Criteria:\n1. Known hypersensitivity to TKI-3212 or its excipients.\n2. Presence of EGFR mutations or ALK rearrangements for which targeted therapy is available.\n3. Active brain metastases or leptomeningeal metastases. Patients with previously treated brain metastases may participate if they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids.\n4. History of interstitial lung disease or pneumonitis that required steroid treatment, or current pneumonitis.\n5. Active, known, or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n6. Receipt of a live vaccine within 30 days prior to the first dose of trial treatment.\n7. Any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast.\n8. Major surgery within 4 weeks prior to study entry.\n9. Known history of HIV infection, hepatitis B, or hepatitis C.\n10. Pregnant or breastfeeding women.\n11. Any other condition that would, in the Investigator\u2019s judgment, contraindicate the patient\u2019s participation in the clinical study due to safety concerns or compliance with clinical study procedures.",
        "output": "{\"inclusion_biomarker\": [[\"MET exon 14 skipping mutation\"]], \"exclusion_biomarker\": [[\"EGFR mutation\"], [\"ALK rearrangement\"]]}"
    },
    {
        "input": " A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of AZD9291 in Combination with Bevacizumab in Patients with EGFR-mutant Non-Small Cell Lung Cancer (NSCLC) after Progression on a Previous EGFR-TKI\n;\n;\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of stage IIIB/IV NSCLC.\n2. Documented evidence of EGFR mutation (exon 19 deletions or exon 21 L858R substitution mutations) by a CLIA-certified laboratory (or equivalent).\n3. Progression on or after treatment with an FDA-approved EGFR-TKI.\n4. Measurable disease according to RECIST v1.1 criteria.\n5. Age \u2265 18 years.\n6. ECOG performance status of 0 or 1.\n7. Adequate organ and marrow function.\n8. Ability and willingness to comply with the study and follow-up procedures.\n9. Ability to understand and willingness to sign a written informed consent document.\n10. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria:\n1. Presence of T790M mutation.\n2. Prior treatment with AZD9291 or any other EGFR T790M targeting agent.\n3. Prior treatment with bevacizumab or other VEGF targeting therapies.\n4. Brain metastases that are symptomatic or require treatment. Patients with previously treated brain metastases that are asymptomatic without requiring steroids for at least 4 weeks before starting study drug are eligible.\n5. History of another malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n7. Pregnant or breastfeeding women.\n8. Known hypersensitivity to AZD9291, bevacizumab, or any of their excipients.\n9. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR exon 19 deletion\"], [\"EGFR exon 21 L858R\"]], \"exclusion_biomarker\": [[\"EGFR T790M\"]]}"
    },
    {
        "input": " A Randomized Phase III Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination with Axitinib versus Sunitinib Monotherapy in Treatment-Na\u00efve Patients with Advanced Renal Cell Carcinoma with Sarcomatoid Features\n;\n;\nInclusion Criteria:\n1. Histologically confirmed diagnosis of renal cell carcinoma (RCC) with sarcomatoid features.\n2. Advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC.\n3. No prior systemic therapy for advanced RCC.\n4. Presence of at least one measurable lesion as defined by RECIST 1.1.\n5. Age \u2265 18 years.\n6. ECOG performance status of 0 or 1.\n7. Adequate organ function.\n8. Must have tissue available for PD-L1 biomarker analysis.\n9. Must be able to swallow and retain orally administered medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.\n10. Written informed consent and any locally required authorization (e.g., HIPAA in the USA, GDPR in the EU) obtained from the patient/legal representative.\n\nExclusion Criteria:\n1. Known additional malignancy that is progressing or requires active treatment except for basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n2. Active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n3. Participants with active, known or suspected autoimmune disease.\n4. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n5. Active infection requiring systemic therapy.\n6. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n7. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n8. Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n9. Known history of Hepatitis B (e.g., Hepatitis B surface antigen reactive) or known active Hepatitis C virus (e.g., HCV RNA [qualitative] is detected).\n10. Patients who have had chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial treatment start or who have not recovered from adverse events due to a previously administered agent.",
        "output": "{\"inclusion_biomarker\": [], \"exclusion_biomarker\": []}"
    },
    {
        "input": " A Phase II, Open-Label Study to Evaluate the Efficacy and Safety of AZD9291 in Combination with Bevacizumab in Patients with EGFR-mutant Non-Small Cell Lung Cancer (NSCLC) After Progression on a Previous EGFR-TKI\n;\n;\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC with an activating mutation in EGFR (exon 19 deletions or L858R substitution mutations).\n2. Documented disease progression during or after treatment with an FDA-approved EGFR-TKI.\n3. Measurable disease according to RECIST 1.1.\n4. Age \u2265 18 years.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ and marrow function.\n7. Must have at least one lesion not previously irradiated that can be accurately measured at baseline as \u226510 mm in the longest diameter (except lymph nodes which must have a short axis \u226515 mm) with CT or MRI and which is suitable for accurate repeated measurements.\n8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the completion of therapy.\n9. Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n1. Participants with mutations in EGFR T790M, exon 20 insertions, or other resistance mutations not amenable to AZD9291 treatment.\n2. Prior treatment with any other EGFR-TKI or bevacizumab.\n3. Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids to control their CNS disease.\n4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD9291 or bevacizumab.\n5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n6. Pregnant or breastfeeding women.\n7. Known HIV-positive individuals on combination antiretroviral therapy.\n8. Any other malignancies within 3 years except for cancers with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ treated surgically with curative intent.\n9. Presence of a gastrointestinal tract disease causing the inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR exon 19 deletion\"], [\"EGFR L858R\"]], \"exclusion_biomarker\": [[\"EGFR T790M\"], [\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A Randomized, Double-Blind Phase III Trial to Assess the Efficacy of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Combination with Standard Chemotherapy in Patients with Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer\n;\n;\nInclusion Criteria:\n1. Histologically confirmed diagnosis of metastatic colorectal cancer (CRC) that is MSI-H or dMMR as determined by a local laboratory test.\n2. No prior systemic chemotherapy for metastatic CRC. Adjuvant chemotherapy is allowed if completed more than 6 months prior to enrollment.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. Measurable disease according to RECIST 1.1.\n6. Adequate organ and marrow function.\n7. Ability to swallow and retain oral medication.\n8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the last dose of study drug.\n9. Signed informed consent and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n1. Known BRAF V600E mutation (patients with BRAF non-V600E mutations are eligible).\n2. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to enrollment.\n3. Known CNS metastases and/or carcinomatous meningitis.\n4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to JNJ-63723283 or other agents used in the study.\n5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n6. Pregnant or breastfeeding women.\n7. Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n8. Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).\n9. Live vaccine within 30 days prior to the first dose of trial treatment.\n10. Any other condition that would, in the Investigator\u2019s judgment, contraindicate the patient\u2019s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc.",
        "output": "{\"inclusion_biomarker\": [[\"MSI-H\"], [\"dMMR\"]], \"exclusion_biomarker\": [[\"BRAF V600E mutation\"]]}"
    },
    {
        "input": " A Phase II, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of AZD9291 (Osimertinib) in EGFR T790M Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of First-Line EGFR TKI Therapy\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.\n2. Documented evidence of T790M mutation in the EGFR gene as detected by a validated and sensitive assay.\n3. Disease progression during or after treatment with a first-line EGFR TKI (e.g., erlotinib, gefitinib, or afatinib).\n4. Age \u2265 18 years.\n5. ECOG performance status of 0-2.\n6. At least one measurable lesion as defined by RECIST v1.1.\n7. Adequate bone marrow, liver, and renal function.\n8. Ability and willingness to provide informed consent.\n\nExclusion Criteria:\n1. Presence of exon 20 insertion mutations in the EGFR gene.\n2. Prior treatment with third-generation EGFR TKIs (e.g., osimertinib).\n3. Treatment with more than one line of chemotherapy or any other targeted therapy for advanced NSCLC.\n4. Known symptomatic brain metastases requiring steroids, or brain metastases that are not stable for > 4 weeks prior to start of study treatment.\n5. History of interstitial lung disease or pneumonitis.\n6. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n7. Pregnant or breastfeeding women.\n8. Known hypersensitivity to AZD9291 or any of its excipients.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"EGFR T790M\"]], \"exclusion_biomarker\": [[\"EGFR exon 20 insertion\"]]}"
    },
    {
        "input": " A Randomized, Open-Label Phase III Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Homologous Recombination Repair (HRR) Gene Mutations\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed diagnosis of mCRPC.\n2. Presence of a deleterious or suspected deleterious HRR gene mutation (e.g., BRCA1, BRCA2, ATM, CHEK2) identified through a validated genomic assay.\n3. Ongoing androgen deprivation therapy with a GnRH analog or bilateral orchiectomy (i.e., must be surgically or medically castrated).\n4. Progressive disease as evidenced by one or more of the following: a rise in serum PSA, progression of pre-existing disease, or appearance of new metastases.\n5. ECOG performance status of 0-1.\n6. Adequate organ function.\n\nExclusion Criteria:\n1. Prior systemic therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).\n2. Treatment with more than two lines of chemotherapy for mCRPC.\n3. Known mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H) cancer.\n4. Active autoimmune disease that has required systemic treatment in the past 2 years.\n5. Prior treatment with enzalutamide or any other second-generation anti-androgen therapy.\n6. Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.\n7. Uncontrolled or significant cardiovascular disease, including recent myocardial infarction, congestive heart failure, unstable angina, or serious cardiac arrhythmia requiring medication.\n8. Active infection requiring systemic therapy.\n9. A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.",
        "output": "{\"inclusion_biomarker\": [[\"BRCA1 mutation\", \"BRCA2 mutation\", \"ATM mutation\", \"CHEK2 mutation\"]], \"exclusion_biomarker\": [[\"dMMR\"], [\"MSI-H\"]]}"
    },
    {
        "input": " A Phase II, Open-Label Study Evaluating the Efficacy and Safety of AZD6738 in Combination with Olaparib in Patients with Advanced Solid Tumors Harboring Homologous Recombination Repair (HRR) Gene Mutations\n\nInclusion Criteria:\n1. Histologically or cytologically confirmed advanced solid tumors with documented HRR gene mutations (including but not limited to BRCA1, BRCA2, ATM, CHEK2, RAD51).\n2. Age \u2265 18 years.\n3. ECOG performance status of 0 or 1.\n4. Measurable disease according to RECIST 1.1 criteria.\n5. Prior chemotherapy, targeted therapy, or immunotherapy is allowed, provided there has been recovery to baseline or \u2264 Grade 1 from adverse effects.\n6. Adequate bone marrow, liver, and renal function as evidenced by laboratory values.\n7. Patients must be willing to undergo a fresh tumor biopsy unless sufficient archival tissue is available for confirmation of HRR gene mutation status.\n8. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the last dose.\n\nExclusion Criteria:\n1. Known mutations in genes that confer resistance to PARP inhibitors (e.g., BRCA1/2 reversion mutations).\n2. Prior treatment with a PARP inhibitor or ATR inhibitor.\n3. Active brain metastases or leptomeningeal disease. Patients with previously treated brain metastases that are stable for \u2265 4 weeks following treatment and without steroid requirement for at least 7 days before starting study treatment are eligible.\n4. Significant cardiovascular disease, such as heart failure meeting New York Heart Association Class III or IV classification, uncontrolled hypertension, or history of myocardial infarction within the last 6 months.\n5. Concurrent use of other anti-cancer therapies or participation in another clinical trial with therapeutic intent.\n6. Pregnant or breastfeeding women.\n7. Known hypersensitivity to AZD6738, olaparib, or any excipients in the formulations.\n\n",
        "output": "{\"inclusion_biomarker\": [[\"HRR mutation\"], [\"BRCA1 mutation\"], [\"BRCA2 mutation\"], [\"ATM mutation\"], [\"CHEK2 mutation\"], [\"RAD51 mutation\"]], \"exclusion_biomarker\": [[\"BRCA1 mutation\"], [\"BRCA2 mutation\"]]}"
    },
    {
        "input": " A Randomized Phase III Trial of Personalized Neoantigen Vaccine NEO-PV-01 with Nivolumab and Ipilimumab in Patients with Melanoma with High-Risk Genomic Features\n\nInclusion Criteria:\n1. Histologically confirmed melanoma with high-risk genomic features, including but not limited to BRAFV600 mutation, NRAS mutation, or loss of function mutations in PTEN or CDKN2A.\n2. Stage III (unresectable) or IV melanoma patients.\n3. Age \u2265 18 years.\n4. ECOG performance status of 0 or 1.\n5. Patients must have measurable disease based on RECIST 1.1 criteria.\n6. Adequate organ function as defined by study-specific laboratory tests.\n7. Willingness to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment.\n8. Patients must be willing to undergo blood sampling for immune monitoring and neoantigen vaccine production.\n9. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of the study treatment.\n\nExclusion Criteria:\n1. Presence of any other active malignancy other than melanoma. Patients with history of malignancy that have been completely treated, with no evidence of disease for \u2265 5 years are allowed.\n2. Prior therapy with any checkpoint inhibitor (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies) or cancer vaccine.\n3. Known hypersensitivity to nivolumab, ipilimumab, or any component of the NEO-PV-01 vaccine.\n4. Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids.\n5. Any condition that, in the opinion of the investigator, contraindicates the patient's participation due to safety concerns or compliance with clinical study procedures, e.g., infection, gastrointestinal tract disease causing an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, and uncontrolled inflammatory GI disease.\n6. Pregnant or breastfeeding women.\n7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.",
        "output": "{\"inclusion_biomarker\": [[\"BRAF V600\", \"NRAS mutation\", \"PTEN loss of function mutation\", \"CDKN2A loss of function mutation\"]], \"exclusion_biomarker\": []}"
    }
]