araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Study of LY2875358 in Non Small Cell Lung Cancer (NSCLC) Participants

Summary: The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.


Eligibility: Inclusion Criteria:
  -  Diagnosis of metastatic Stage IV NSCLC
  -  At least 1 measurable extra-central nervous system (CNS) lesion
  -  Documented radiographic progression while on continuous treatment with erlotinib monotherapy
  -  Objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (EGFRmt) status, at least 12 weeks stable disease
  -  Determined to be MET diagnostic positive (+)
  -  Availability of a tumor sample post-erlotinib progression
  -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  -  Have adequate organ function
  Exclusion Criteria:
  -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
  -  Have previously been treated with LY2875358 or any other MET-targeting experimental therapeutic
  -  Have a serious concomitant systemic disorder or significant cardiac disease
  -  Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
  -  Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
  -  Have major surgery less than 2 weeks prior initiation of study treatment therapy
  -  Pregnant or lactating women
  -  Have symptomatic CNS metastasis

Relevance to patient case: definitely relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib

Summary: The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.


Eligibility: Select Inclusion Criteria:
  1. Histological or cytological diagnosis of HCC.
  2. The subject has disease that is not amenable to a curative treatment approach.
  3. Received prior sorafenib.
  4. Progression following at least 1 prior systemic treatment for HCC.
  5. Recovery to from toxicities related to any prior treatments.
  6. ECOG performance status of 0 or 1.
  7. Adequate hematologic and renal function, based upon meeting protocol defined laboratory criteria within 7 days before randomization.
  8. Child-Pugh Score of A.
  9. Antiviral therapy per local standard of care if active hepatitis B (HBV) infection.
  10. Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
  11. Female subjects of childbearing potential must not be pregnant at screening.
  Select Exclusion Criteria:
  1. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
  2. Receipt of more than 2 prior systemic therapies for advanced HCC.
  3. Any type of anticancer agent (including investigational) within 2 weeks before randomization.
  4. Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment within 6 weeks of randomization.
  5. Prior cabozantinib treatment.
  6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
  7. Concomitant anticoagulation, at therapeutic doses, with anticoagulants.
  8. Serious illness other than cancer that would preclude safe participation in the study.
  9. Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding.
  10. Moderate or severe ascites.
  11. Pregnant or lactating females.
  12. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low-grade tumors.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Value of Physical Capacity Tests in Lung Cancer

Summary: The study examines the physical capacity of lung cancer patients assessed with the six minute walk test and handgrip strength. Demographic and selfreported exercise behavior is registered to explore correlations to functional and physical capacity.
  Assessments are made before first chemotherapy cycle and after fourth chemotherapy cycle, an expected average of 12 weeks between first and second assessment.


Eligibility: Inclusion Criteria:
  -  Non small cell lung cancer stage I-IV
  -  Small cell lung cancer
  -  Patients >18 years
  -  WHO performance status 0-2
  -  undergoing chemotherapy
  Exclusion Criteria:
  -  unstable angina during the previous month
  -  myocardial infarction diagnosed within the last month
  -  not approval for physical activity by primary oncologist
  -  inability to provide informed consent.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

Summary: To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
  -  treatment-naïve or have received no more than 3 systemic treatment regimen(s)
  -  Positive for translocation or inversion events involving the ROS1 gene
  -  Negative for translocation or inversion events involving the ALK gene
  -  Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications
  -  Any prior treatment (chemotherapy, radiation [except for palliative], or surgery) must have been completed at least 2 weeks prior to initiation of study medication
  -  At least 1 measurable tumor lesion as per RECIST v1.1
  -  Female or male, 18 years of age or older
  -  ECOG performance status 0 to 1
  -  Adequate organ function
  -  Signed and dated informed consent
  -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures
  -  Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment
  Exclusion Criteria:
  -  Current treatment on another therapeutic clinical trial
  -  Prior therapy specifically directed against ALK or ROS1 fusion genes
  -  Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease
  -  known interstitial fibrosis or interstitial lung disease
  -  myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment
  -  Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >/=2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec
  -  Pregnant or breast feeding
  -  Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
  -  Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list
  -  Evidence of active malignancy within last 3 years

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Study of Efficacy and Safety INC280 in Patients With Advanced Hepatocellular Carcinoma

Summary: This study is establish whether INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose disease progressed while on, or after, treatment with sorafenib or who are intolerant to sorafenib.
  Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280 treatment upon documented further disease progression (RECIST 1.1) per investigator's discretion after unblinding.
  Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).

Detailed description: Study was cancelled by Sponsor prior to enrollment of patients.

Eligibility: Inclusion Criteria:
  -  Confirmed c-MET pathway dysregulation.- Hepatocellular carcinoma stage B or C according to the Barcelona Clinic Liver cancer staging classification. - Current cirrhotic status of Child-Pugh class A with no encephalopathy. - Documented disease progression during or after discontinuation of sorafenib treatment or intolerance to sorafenib treatment. - Measurable disease as determined by RECIST v1.1. - ECOG performance status ≤ 1
  Exclusion Criteria:
  -  Previous local antineoplastic therapy or investigational drug completed less than 5 half-lives of the agent prior to randomization and have not recovered from clinically significant toxicity from such treatment to grade ≤1 by the NCI-CTCAE. - Received any targeted therapy other than sorafenib.
  -  Active bleeding within 28 days prior to screening visit including variceal bleeding (esophageal varices should be treated according to standard practice and procedure completed 28 days prior to screening visit). - Clinically significant venous or arterial thrombotic disease within past 6 months.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment

Summary: This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR) participants treated with Tarceva after at least one failed chemotherapy treatment, and the impact of prior chemotherapy treatments.


Eligibility: Inclusion Criteria:
  -  Adults >/= 18 years
  -  Histologically documented locally advanced, metastatic, or recurrent non-small cell lung carcinoma with wild-type EGFR eligible for Tarceva treatment.
  -  At least one failed chemotherapy treatment.
  Exclusion Criteria:
  - Unknown EGFR mutation status

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Circulating Fibrocytes in Non-small Cell Lung Cancer.

Summary: The investigators will collect fibrocytes (CD45+Col-1+) in patients with non-small cell lung cancer (NSCLC). The investigators hypothesize that patients with NSCLC experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in NSCLC patients.

Detailed description: Fibrocytes have been described in both mice and humans, where they bear a hematopoietic progenitor phenotype (CD45+Col-1+). Fibrocytes have previously been described in murine cancer, implicated as mediators of tumor immune escape. In this study, the investigators will collect fibrocytes including CD45+Col-1+ expression. The cells express indoleamine oxidase, which is primarily responsible for their immunosuppressive properties. The investigators hypothesize that patients with non-small cell lung cancer experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in non-small cell lung cancer patients.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
  Exclusion Criteria:
  -  Combination of other malignancy.
  -  Age less than 20 years (not include 20 years).
  -  Pregnancy.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer

Summary: The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.


Eligibility: Key Inclusion Criteria:
  -  Male or female at least 18 years of age
  -  Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)
  -  Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Adequate hematologic, renal and hepatic function
  Exclusion Criteria:
  -  Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC
  -  Known history of bleeding disorders, eg, von Willebrand disease or hemophilia
  -  Cavitary tumors or tumors invading or abutting large blood vessels
  -  Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening
  -  Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening
  -  Grade 2 or higher peripheral neuropathy

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Comparison of qPCR to IHC and FISH for Detection of ALK Fusion Mutations in FFPE Tissue From NSCLC Patients

Summary: The anaplastic lymphoma kinase gene(ALK) is mutated approximately 5% of non-small cell lung cancers. Testing for this gene is important because there are drugs known as ALK inhibitors that have been shown to significantly delay the progression of ALK-mutated lung cancers. There are a number of ways to test for the presence of the ALK gene in lung cancer biopsy tissue. One method involves making slides and staining them to detect the ALK protein. This is called immunohistochemistry. Another method called fluorescence in situ hybridization(FISH)is used to detect rearrangements of the ALK gene associated with lung cancer. Although both these tests are widely used to test for ALK gene abnormalities, the techniques may not always find the ALK gene mutation because they are not sensitive enough or not enough cancer cells are present in the lung biopsy.
  This study is being performed to determine if a technique called quantitation polymerase chain reaction (qPCR) is as accurate or better at finding the ALK gene mutation in lung cancer biopsy tissue.


Eligibility: Inclusion Criteria:
  -  You have a confirmed diagnosis of non-squamous, non-endocrine non-small cell lung cancer.
  -  Your cancer biopsy has sufficient cancer cells to be tested for the (Epidermal Growth Factor Receptor (EGFR) mutation, the ALK fusion gene abnormality and the research ALK testing.
  -  Your lung cancer biopsy is determined not to have a mutation in the EGFR gene.
  -  You are 19 years old or older.
  -  You fully understand the study and give informed consent to participate as demonstrated by signing the consent.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors

Summary: This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG 337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the objective response rate of AMG 337 by tumor type.

Detailed description: This is a phase 2, multicenter, single arm, 2 cohort study to assess the safety, efficacy and pharmacokinetics of AMG 337 in MET amplified Gastric/esophageal adenocarcinoma or other solid tumors. Approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified G/E adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor/up to 10 subjects with MET amplified G/E adenocarcinoma with non-measurable tumor/up to 10 subjects who have received prior MET antibody therapy). All subjects will self-administer AMG 337 300 mg daily until disease progression or other protocol specified end of treatment criteria is met.
  Tumor tissue, biomarkers, Pharmacokinetics and Patient reported Outcomes will all be assessed.
  Tumor assessment by RECIST 1.1 will be followed during study treatment.

Eligibility: Inclusion Criteria:
  -  Able to daily self-administer AMG 337 orally as a whole capsule
  -  Male or female 18 years of age or over.
  -  Pathologically confirmed advanced G/GEJ/E adenocarcinoma (Cohort 1) or other solid tumor (Cohort 2) for which subject has received prior therapy for advanced disease, for which no standard therapy exists, or subject refuses standard therapy
  -  Tumor MET amplified by protocol-specified centralized testing.
  -  Measurable disease per RECIST 1.1 guidelines. Cohort 2 may include up to 10 subjects with advanced MET amplified, G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1
  -  (ECOG) Performance Status of 0, 1 or 2
  Exclusion Criteria:
  -  Known central nervous system metastases
  -  Candidate for curative surgery or definitive chemoradiation
  -  Peripheral edema > grade 1
  -  Persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding. Significant gastrointestinal disorder(s) that in the opinion of the Investigator may influence drug absorption
  -  Acute Hepatitis B. Chronic Hepatitis B eligible if condition is stable and, in the opinion of the investigator or Amgen physician, if consulted, would not pose a risk to subject safety
  -  Detectable Hepatitis C virus (indicative of active Hepatitis C)
  -  Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment
  -  Prior treatment with small molecule inhibitors of the MET pathway.
  Other protocol defined inclusion criteria may apply.

Relevance to patient case: possibly relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)

Summary: The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic chemotherapy regimen including sorafenib.


Eligibility: Inclusion Criteria:
  -  Informed consent form
  -  ≥20 years old
  -  Inoperable HCC which is not eligible for locoregional therapy
  -  Diagnosed as c-Met high in tumor sample
  -  Radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy.
  -  Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1
  -  Child-Pugh Class A
  -  Having measurable target lesions which are defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1,
  -  Negative pregnancy test results
  -  Adequate organ function
  -  Life expectancy of at least 12 weeks
  Exclusion Criteria:
  -  More than 2 prior systemic chemotherapy.
  -  Prior therapy of c-Met inhibitor (including antibody)
  -  Any systemic therapy within ≤2 weeks prior to the randomization
  -  Locoregional therapy within ≤4 weeks prior to randomization.
  -  Major surgery within ≤4 weeks prior to the randomization
  -  Concurrent cancer within ≤5 years prior to the randomization
  -  History of cardiac diseases
  -  Active clinically serious infections defined as ≥ Grade 3 according to Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0
  -  Any psychological disorder affecting Informed Consent
  -  Diagnosis positive for anti-HIV antibody and/or anti-HTLV-1 antibody
  -  Blood or albumin transfusion within ≤14 days prior to the screening test
  -  Concurrent interferon therapy against Hepatitis B Virus (HBV)/ Hepatitis C Virus (HCV)
  -  Symptomatic brain metastases
  -  History of liver transplantation
  -  Inability to swallow oral medications
  -  Confirmed interstitial lung disease
  -  Pleural effusion and/or clinically significant ascites
  -  Pregnancy or breast-feeding
  -  Without consent to effective single or combined contraceptive methods

Relevance to patient case: not relevant