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 Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer

Summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive 4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically or cytologically confirmed Stage IIIB or Stage IV non-squamous non-small cell lung cancer (NSCLC)
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  -  For patients who received prior adjuvant chemotherapy or chemoradiotherapy: a treatment-free interval of at least 12 months since last chemotherapy or chemoradiotherapy cycle
  -  Adequate tissue for central immunohistochemical (IHC) assay of Met receptor, and epidermal growth factor receptor (EGFR) testing if EGFR status is unknown
  -  Radiographic evidence of disease
  Exclusion Criteria:
  -  Prior systemic treatment for Stage IIIB or IV non-squamous NSCLC
  -  Evidence of mixed NSCLC with a predominance of the squamous cell type
  -  Prior exposure to experimental treatment targeting either the hepatocyte growth factor (HGF) or Met pathway
  -  Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator, unless that treatment is unavailable or refused by the patient
  -  Known central nervous system (CNS) disease, other than stable, treated brain metastases
  -  History of another malignancy in the previous 3 years, except for history of in situ cancer that was treated surgically with curative intent, localized prostate cancer that has been treated surgically with curative intent, or basal or squamous cell skin cancer
  -  Uncontrolled diabetes
  -  Pregnant or lactating women
  -  Impaired bone marrow, liver or renal function (as defined by protocol)
  -  Significant history of cardiovascular disease
  -  Positive for HIV infection

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

Clinical trial: Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation

Summary: The purpose of this study is to establish whether patients with malignancy harboring a discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to dasatinib.


Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
  Inclusion Criteria:
  -  Diagnosis of advanced malignancy, nonsmall-cell lung cancer (NSCLC) only during stage 1 of accrual
  -  Nonsynonymous mutation of B-RAF or DDR2, defined as follows:
  -  NSCLC with inactivating B-RAF mutation
  -  NSCLC with discoidin domain receptor 2 (DDR2) mutation
  -  Malignancy of other histology with DDR2 mutation or inactivating B-RAF mutation, or NSCLC having a B-RAF mutation that is not functionally characterized
  -  At least 1 target lesion per Response Evaluation Criteria in Solid Tumors, vol 1.1, on baseline staging evaluation
  -  Disease progression after ≥ 1 prior treatment regimen
  Exclusion Criteria:
  -  Pleural or pericardial effusion, Grade >1
  -  QTcF >470 msec (Grade ≥2) or diagnosed congenital long QT syndrome
  -  Absolute granulocyte count <1500/mm^3
  -  Hemoglobin level <10 g/dL
  -  Platelet count < 75,000/mm^3
  -  Serum calcium level <institutional lower limit of normal
  -  Hypokalemia, hypophosphatemia, or hypomagnesemia, Grade >1, despite supplementation
  -  Creatinine >3*institutional upper limit of normal (ULN)
  -  Total bilirubin level >1.5*ULN
  -  Alanine transaminase level >3*ULN

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

Clinical trial: A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

Summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  -  No prior chemotherapy for squamous NSCLC
  -  Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
  -  Radiographic evidence of disease
  Exclusion Criteria:
  -  Prior systemic treatment for Stage IIIB or IV squamous NSCLC
  -  NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
  -  Prior exposure to experimental treatment targeting either the HGF or Met pathway
  -  Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
  -  Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1
  -  History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer
  -  Pregnant or lactating women
  -  Uncontrolled diabetes
  -  Impaired bone marrow, liver or renal function as defined by protocol
  -  Significant history of cardiovascular disease
  -  Positive for HIV infection

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

Clinical trial: A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response

Summary: 1. Trial design: Prospective observational study
  2. Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria
  3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib
  -  C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR
  4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival )
  5. Duration of Trial Recruitment: 2 years


Eligibility: Inclusion Criteria:
  -  Informed consent
  -  19~80 year old male or female
  -  Histologically proven advanced or metastatic NSCLC
  -  Failed to 1st line chemotherapy
  -  Tumor tissue for genetic analysis
  -  Evaluable target lesion by RECIST v1.1
  -  ECOG performance from 0 to 3
  -  Expected survival more than 12 weeks
  Exclusion Criteria:
  -  Previous treatment of EGFR-tyrosine kinase inhibitors
  -  Severe hypersensitivity to erlotinib
  -  Residual toxicities (above grade 2) after previous chemotherapy
  -  Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits

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

Clinical trial: Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy

Summary: Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC under daily-life treatment conditions.


Eligibility: Inclusion Criteria:
  -  Patients with histologically/cytologically confirmed HCC or radiographically diagnosed as per AASLD criteria, who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made
  -  Patients must have signed the informed consent form
  -  Patients must have a life expectancy of at least 8 weeks Inclusion criteria must follow the approved local product information.
  Exclusion Criteria:
  -  Prior treatment with sorafenib
  -  Concomitant participation in other clinical studies Exclusion criteria must follow the approved local product information.

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

Clinical trial: ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer

Summary: The primary objective of this study is to examine if the combination regimen of ARQ 197 with erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating mutation EGFR who progressed on EGFR-TKI monotherapy.


Eligibility: Key Inclusion Criteria:
  -  Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation.
  -  Measurable disease and documented disease progression following the first and immediate EGFR-TKI monotherapy.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  -  Adequate organ function
  Key Exclusion Criteria:
  -  Prior therapy with a c-Met inhibitor.
  -  Any systemic anti-tumor treatment for NSCLC within 7 days prior to randomization.
  -  Major surgical procedure within 4 weeks prior to randomization
  -  Known symptomatic brain metastases.

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

Clinical trial: A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment

Summary: This study will assess the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that are known to have dysregulation of the c-MET pathway and who have failed after benefiting on a prior treatment with either gefitinib or erlotinib.

Detailed description: Patients will be treated INC280 and gefitinib(250mg) daily. Dose escalation for INC280 will be performed. Each cohort for the phase IB part will consist of 3 to 6 newly enrolled patients. A twice daily administration of INC280 may be investigated if deemed appropriate based on emerging results from ongoing clinical trials.

Eligibility: Inclusion Criteria:
  -  Documented EGFR mutation
  -  Documented c-MET dysregulation
  -  Prior clinical benefit on EGFR inhibitors and then subsequent progression
  -≥ 18 year old
  -  Life expectancy of ≥ 3 months
  -  ECOG performance status ≤ 2
  Exclusion Criteria:
  -  Unable to swallow tables once or twice daily
  -  Previous treatment with c-MET inhibitor
  -  Any unresolved toxicity form previous anticancer therapy greater than grade 1
  -  History of cystic fibrosis
  -  History of acute or chronic pancreatitis
  -  Unable to undergo MRI or CT sans
  -  Known history of HIV
  -  Undergone a bone marrow or solid organ transplant
  -  Clinically significant wound or lung tumor lesions with increased likelihood of bleeding
  -  Pregnant or nursing
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer

Summary: The purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant tissue.


Eligibility: Inclusion Criteria:
  -  Inclusion Criteria Patients (12 total patients with lung cancer) meeting eligibility criteria will be enrolled.
  -  Preoperative diagnosis of either presumed or documented non-small cell lung cancer.
  -  Tumor judged to be suitable for surgical resection based on preoperative evaluation of radiographic studies, pulmonary function tests, performance status and clinical judgment of surgeons at DHMC (Erkmen, Nugent)
  -  Age ≥ 18 years old.
  -  Population representative of our usual referral pattern including minority populations, women and those who are financially disadvantaged.
  -  Subjects capable of giving informed consent
  Exclusion Criteria:
  -  Pregnant Women
  -  Women who are breast feeding
  -  History of cutaneous photosensitivity
  -  Porphyria, hypersensitivity to porphyrins, photodermatosis
  -  Exfoliative dermatitis
  -  History of liver disease within the last 12 months
  -  Inability to comply with photosensitivity precautions associated with the study
  -  Inability to give informed consent
  -  AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit at any time during the past 2 months
  -  Plasma creatinine in excess of 180 umol/L
  -  Women who are breast feeding
  -  History of cutaneous photosensitivity
  -  Porphyria, hypersensitivity to porphyrins, photodermatosis
  -  Exfoliative dermatitis
  -  History of liver disease within the last 12 months
  -  Inability to comply with photosensitivity precautions associated with the study

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

Clinical trial: Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers

Summary: Our project, established through collaboration between clinicians (Oscar Lambret Center-University Hospital) and scientists (IBL), aims to evaluate the expression of Met fragments in the lung cancer (LC). Unlike previous studies on Met by sequencing, in situ hybridization or immunohistochemistry, the investigators propose a protein analysis by Western blot of tumor samples and healthy tissue. This approach will evaluate the expression of full-length receptor, the potential presence of intracellular fragments, and their phosphorylation status.

Detailed description: -  Patient information and collection of signed inform consent
  -  Blood sample collection before bronchoscopy or before surgery, at the same time as a usual blood assessment.
  -  Prospective collection of bronchial biopsies of patients with metastatic non small cell lung cancer, during a bronchoscopy at the Oscar Lambret Center (Dr Dansin)
  -  Prospective collection of resected specimens of patients with localized non small cell lung cancer, who were operated at the thoracic surgery unit of the University hospital (Pr Porte)
  -  Transportation of the samples to the pathology laboratories (Dr Robin, Pr Copin)
  -  Selection of blocks of interest and preparation of tumor samples
  -  Clinical data collection : date of biopsy or surgery, disease-free survival, overall survival, tumor characteristics, EGFR status, ALK, BRAF, HER2
  -  Transportation of tumor blocks and blood samples to the Institute of Biology of Lille for analyses: Western blot, immunohistochemistry and ELISA test)
  -  Return to storage of the tumor samples at the Oscar Lambret Center and at the University hospital of Lille

Eligibility: Inclusion Criteria:
  -  Patients with non small cell lung cancer (NSCLC)
  -  Patients candidate for bronchial biopsies at the Oscar Lambret Center (metastatic stage) or candidate for thoracic surgery at University Hospital of Lille (localized stage)
  -  Treatment naive patient for metastatic NSCLC
  -  Patients with or without neoadjuvant therapy for localized NSCLC
  -  Male or female patients aged ≥ 18 years
  -  Patient registered with the social security system
  -  Having signed a written Informed Consent
  Exclusion Criteria:
  -  Malignant tumors which are not carcinoma
  -  Small-cell malignant tumors
  -  Secondary bronchial lesions
  -  Revision surgery
  -  Pregnant or breastfeeding women
  -  Patient under guardianship or tutorship
  -  Previous cancer

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

Clinical trial: First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma

Summary: This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of epirubicin, cisplatin & capecitabine (ECX) with rilotumumab or placebo for untreated advanced MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma


Eligibility: Key Inclusion Criteria:
  -  Pathologically confirmed unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma •Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1)
  -  Tumor MET-positive by immunohistochemistry (IHC)
  -  Evaluable (measurable or non-measurable) disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
  Key exclusion criteria:
  -  Human Epidermal Growth Factor Receptor 2 (HER2) -overexpressing locally advanced or metastatic gastric or GEJ adenocarcinoma •Previous systemic therapy for locally advanced or metastatic gastric or GEJ adenocarcinoma
  -  Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to randomization
  -  Previous treatment with anthracyclines must not exceed total cumulative dose of epirubicin of 400 mg/m2
  -  Squamous cell histology
  -  Left ventricular ejection fraction (LVEF) < 50%

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

Clinical trial: FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer

Summary: This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.
  Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.


Eligibility: Inclusion Criteria:
  -  Age 18 years or older
  -  Willing and able to provide written informed consent
  -  Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation
  -  Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, < 2 cm)
  -  All imaging evidence used as part of the screening process must be within 28 days
  -  Suitable for either treatment regimen
  -  WHO performance status 0-1
  -  Adequate hematological, renal and hepatic function
  -  Life expectancy of at least 3 months without any active treatment
  Exclusion Criteria:
  -  Evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement or thrombosis as determined by clinical or radiologic assessment
  -  Previous radiotherapy delivered to the liver
  -  Non-malignant disease that would render the patient unsuitable for treatment according to the protocol
  -  Peripheral neuropathy > grade 2 (NCI-CTC)
  -  Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy
  -  Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is permitted provided that it was completed more than 6 months before entry into the study
  -  Pregnant or breast feeding
  -  Concurrent or prior history of cancer other than adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
  -  Allergy to contrast media that would preclude angiography of the hepatic arteries

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

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

Summary: This study is to find out if INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway.

Detailed description: This study is designed as a Phase II, single arm, open-label, multicenter study to evaluate the safety and efficacy of INC280 as first-line treatment in patients with advanced hepatocellular carcinoma (HCC) who are not eligible for or had disease progression after surgical or locoregional therapies, with c- MET dysregulation.
  The study includes a Dose-Determining Part and a Dose Expansion Part. Pharmacokinetic and safety profiles of INC280 in the setting of liver dysfunction will be determined in the Dose-Determining Part. The Dose Expansion Part will start when the appropriate dose for patients with liver dysfunction is determined based on pharmacokinetics (PK) and safety data from the Dose-Determining Part and other INC280 ongoing clinical studies.

Eligibility: Inclusion Criteria:
  -  Confirmed c-MET pathway dysregulation.
  -  Advanced hepatocellular carcinoma which could not be suitable for treatment with locoregional therapies or has progressed following locoregional therapy.
  -  Measurable disease as determined by RECIST version 1.1.
  -  Current cirrhotic status of Child-Pugh class A with no encephalopathy.
  -  Eastern Cooperative Oncology Group (ECOG) performance status < or = 2.
  -  Other protocol-defined inclusion criteria may apply.
  Exclusion Criteria:
  -  Received any prior systemic chemotherapy or molecular-targeted therapy for hepatocellular carcinoma such as sorafenib.
  -  Previous treatment with c-MET inhibitor or hepatocyte growth factor targeting therapy.
  -  Previous local therapy completed less than 4 weeks prior to dosing and, if present, any acute toxicity > grade 1.
  -  Known active bleeding (e.g. bleeding from gastro-intestinal ulcers or esophageal varices) within 2 months prior to screening or with history or evidence of inherited bleeding diathesis or coagulopathy.
  -  Clinically significant venous or arterial thrombotic disease within past 6 months.
  -  History of acute or chronic pancreatitis, surgery of pancreas or any risk factors that may increase risk of pancreatitis.
  -  Other protocol-defined exclusion criteria may apply.

Relevance to patient case: not relevant