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

Clinical trial: Tumor Bank for Blood Samples

Summary: Establishment of a tumor bank, consisting of blood samples of tumor patients and healthy people as controls. The blood samples will be collected systematically together with the corresponding clinical data. The biological samples, the clinical date together with prospective experimental date constitute the entity of the tumor bank.

Detailed description: Recent progress in diagnosis and therapy of cancer diseases can be ascribed mainly to translational research. The relevance of "translational oncology" will only increase in the future -"From bench to bedside" - the swift implementation of new science research results in clinical studies in order to expedite progress in clinical cancer therapy for the benefit of the patient.
  Its almost a matter of course in the medical science today to collect biological samples together with clinical information thereby creating the foundation for future excellent fundamental research.
  The aim of this tumor bank is to consist of biological samples (together with a tissue bank - see EK 260/2003) and isolates of tumor patients and healthy people as controls. The biological samples, the clinical date together with prospective experimental date constitute the entity of the tumor bank. The content of the tumor bank can provide essential material for current and future research (e.g. analyses of prognostic or predictive tumor markers; genetically analysis (polymorphism, mutation, hypermethylation; verification and characterisation of disseminated tumor cells).

Eligibility: Inclusion Criteria:
  -  Male/Female
  -  Age 18 to 90 years max.
  -  Just one current known malignant disease or
  -  Just one current inflammatory disease
  Exclusion Criteria:
  -  Inflammatory disease and malignant disease
  -  multiple malignancies
  -  multiple diseases
  -  underage

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

Clinical trial: A Post Marketing Surveillance As Required By Philippine Food And Drug Administration

Summary: This is a post marketing surveillance which determines the safety profile of the product to Filipinos. This is a FDA requirement for registration.

Detailed description: The Philippine Food and Drug Administration requires that a post marketing surveillance study be conducted nationwide and enroll approximately 3,000 study patients. In cases where the 3,000 patients will not be met, the total sample size can be reduced to 10% of the volume of drug use during the first year of it being marketed. Final sample size will be determined after one year of marketing authorization. The decision to use Torisel must be a joint decision made by the subject and the investigator.
  The investigator must discuss product information with the subject as per usual practice.

Eligibility: Inclusion Criteria:
  -  Subjects that will be included in this post marketing surveillance study must be consistent with the approved label indication of Torisel in the Philippines.
  -  As per approved label indication, patients diagnosed with advanced renal cell carcinoma will be the ones eligible to participate in the study.
  -  The decision to prescribe Torisel will necessarily precede and will be independent of the decision to enroll the patient into the study.
  -  Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  Exclusion Criteria:
  -  Subjects with conditions that are contraindicated with Torisel based on the approved local product document in the Philippines will be excluded in this study. This condition includes: Patients with bilirubin >1.5 x 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 Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer

Summary: The purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. The study will last approximately 2 years.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed squamous Non-small Cell Lung Cancer (NSCLC)
  -  Stage IV disease at time of study entry based on American Joint Committee on Cancer 7th edition
  -  Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1
  -  Required to have a performance status (PS) 0-1
  Exclusion Criteria:
  -  Nonsquamous NSCLC
  -  Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), or VEGF receptor
  -  Previous chemotherapy for NSCLC
  -  Major surgery or received any investigational therapy in the 4 weeks prior to study enrollment
  -  Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
  -  Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)

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

Clinical trial: Phase 1/1b Study of Rilotumumab in Japanese Subjects With Advanced Solid Tumors or Advanced or Metastatic Gastric or GEJ

Summary: This is an open label phase 1/1b study of Rilotumumab in Japanese subjects with advanced solid tumors or metastatic gastric esphagogastric (GEJ) adenocarcinoma.


Eligibility: Key Inclusion Criteria:
  -  Japanese subjects with pathologically confirmed unresectable locally advanced or metastatic carcinoma which is refractory to standard therapies or for which there is no standard therapy (Part 1 only)
  -  Japanese subjects with pathologically confirmed MET-positive (fulfilling the MET IHC criteria as defined by validated IVD [in vitro diagnostic]) unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma (Part 2 only)
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status (0 or 1)
  -  Availability of archival tumor tissue (Part 2 only)
  -  Evaluable (measurable or non-measurable) disease by RECIST 1.1 criteria
  -  Able to tolerate infusions and take oral medications (Part 2 only)
  Key Exclusion Criteria:
  -  Previous systemic therapy (including chemotherapy, biologic, immunotherapy, or investigational therapy) for locally advanced or metstatic gastric or GEJ adenocarcinoma (Part 2 only)
  -  Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemotherapy to enrollment (Part 2 only)
  -  Squamos cell history (Part 2 only)
  -  Known HER2-overexpressing unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma (Part 2 only)
  -  Resectable disease or suitable for definitive chemoradiation
  -  Subjects who have persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding (Part 2 only)
  -  Known central nervous system metastases

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

Clinical trial: The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

Summary: assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer


Eligibility: Inclusion Criteria:
  18~75 years Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer patients who have acceptted combination chemotherapy based on platinum 4 course,SD OR PR,the CR patients should accept 6 course of combination chemotherapy.
  3~8 weeks after patients complete first line chemotherapy(include radiotherapy) Ecog0-2 Expected life time longer than 3 monthes
  Normal laboratory values:
  -  leucocyte ≥ 4×109/L
  -  neutrophil ≥ 1.5×109/L
  -  platelet ≥ 100×109/L
  -  Hemoglobin ≥ 10g/L
  -  ALT and
  -  AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) Signed written informed consent
  Exclusion Criteria:
  -  Patients have used drugs according to protocol
  -  Uncontrolled infection of Bacterial or virus or fungal
  -  Patients with other malignant tumor
  -  Uncontrolled brain metastases
  -  Female patients during their pregnant and lactation period, or patients without contracep

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 RO5424802 in Patients With Non-Small Cell Lung Cancer Who Have ALK Mutation and Failed Crizotinib Treatment

Summary: This open-label, non-randomized, multicenter phase I/II study will evaluate the safety and efficacy of RO5424802 in patients with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of patients will receive escalating doses of RO5424802 orally twice daily. In Part 2, patients will receive the recommended phase II dose of RO5424802 as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, patients without EGFR mutation will be offered continued treatment with RO5424802, patients with EGFR mutations will be offered a combination of RO5424802 and Tarceva (erlotinib).


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Locally advanced or metastatic non-small cell lung cancer (stage IIIB or IV by AJCC 7th)
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Documented ALK rearrangement based on FDA approved test
  -  Prior treatment with crizotinib and progression according to RECIST v1.1 criteria with the last dose of crizotinib within 60 days from enrolment; patients can either be chemotherapy-naïve or have received at least one line of platinum-based chemotherapy
  -  Adequate hematologic, hepatic and renal function
  -  Patients with brain or leptomeningeal metastases are allowed on study if the lesions are asymptomatic without neurological signs and clinically stable for at least 2 weeks
  -  Measurable disease according to RECIST v1.1 prior to administration of study drug
  Exclusion Criteria:
  -  Receipt of any other ALK inhibitors in addition to crizotinib
  -  Receipt of any prior cytotoxic chemotherapy for ALK-positive NSCLC within 4 weeks prior to Day 1. Patients who received crizotinib or any other tyrosine kinase inhibitors need to have a minimum 2-week washout period before the first dose
  -  Active uncontrolled infectious diseases requiring treatment
  -  NCI CTCAE (version 4.03) Grade 3 or higher toxicities due to prior therapy that have not shown improvement and are considered to interfere with current study medication
  -  History of organ transplant
  -  Co-administration of anti-cancer therapies other than those administered in this study
  -  Baseline QTc > 470 ms or baseline symptomatic bradycardia < 45 beats per minute
  -  Pregnant or breastfeeding women
  -  Known HIV positivity or AIDS-related illness
  -  History of significant drug-related allergy (such as anaphylaxis)
  -  Any clinically significant concomitant disease or condition that could interfere with, or for which treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the principal investigator, pose an unacceptable risk to the subject in the study

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

Clinical trial: A Japanese Phase 1 Trial of c-Met Inhibitor MSC2156119J in Subjects With Solid Tumors

Summary: This is a Japanese multicenter, open-label, Phase 1 study to evaluate safety and efficacy of MSC2156119J in subjects with malignant solid tumor which is refractory to standard therapy or to which no effective standard therapy is applicable.


Eligibility: Inclusion Criteria:
  -  A subject with a histologically or cytologically confirmed diagnosis of malignant solid tumor which is refractory to standard therapy or to which no effective standard therapy is applicable
  -  An archived tumor tissue is available or biopsy of tumor tissues can be newly performed
  -  A Japanese male or female, age greater than or equal to (>=) 20 years
  -  A subject who has read the Subject Information Sheet and understood the details of this clinical trial, and is willing and able to give his/her informed consent.
  -  A female of child-bearing potential must have a negative blood pregnancy test result at her screening period. A female subject of child-bearing potential must be willing to avoid pregnancy by using an adequate method of contraception Life expectancy is at least 3 months
  -  Other inclusion criteria apply
  Exclusion Criteria:
  -  Known Human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B
  -  Presence of liver fibrosis or liver cirrhosis that has been histologically diagnosed
  -  Signs or symptoms that suggest transmissible spongiform encephalopathy
  -  Received major surgery within 6 weeks before Day 1 in Cycle 1
  -  Known drug abuse or alcohol abuse
  -  Known hypersensitivity to any of the trial treatment ingredients
  -  Hematological test abnormalities
  -  Renal impairment as defined in the protocol
  -  Liver dysfunction as defined in the protocol
  -  History or presence of central nervous system metastasis
  -  History or presence of disease or condition that may hamper compliance or absorption of the investigational medicinal product (IMP) due to difficulty in swallowing or absorption
  -  Poor performance status of Eastern Cooperative Oncology Group Performance status (ECOG PS) >= 2
  -  Received any anti-cancer therapy days Received extensive prior radiotherapy that irradiates more than 30 percent of bone marrow
  -  Received any radiotherapy within 4 weeks before Day 1 in Cycle 1
  -  Pregnancy and lactation period
  -  History of receiving treatment with any c-Met signaling pathway inhibitor
  -  Participation in another interventional clinical trial within the past 30 days from Day 1 in Cycle 1
  -  Other significant disease that in the Investigator's opinion would exclude the subject from the trial
  -  Legal incapacity or limited legal capacity
  -  Other exclusion criteria apply

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

Clinical trial: Possible New Therapy for Advanced Cancer

Summary: IL-13-PE is a chemical similar to one made by the body that is connected to a toxin to specifically attack cancer cells. Researchers want to look at different doses of IL-13-PE to find one that may be safe and effective against cancer that has returned, spread to other organs, or that cannot be surgically removed.
  Participants will receive physical exams and report side effects. Blood and urine samples will be collected. Imaging studies, tissue samples, and other tests will be used to study the tumor before the start of treatment and during the study. IL-13-PE therapy will be given to each participant on days 1, 3 and 5 of each monthly cycle for up to 4 monthly cycles.
  The study will be done in two parts, with a six-month period between them. If the cancer continues to grow, participants will stop taking IL-13-PE. If the cancer continues to shrink or not grow the study will continue, even into a follow-up period after the second part of the study.
  The first part of this study will determine how much IL-13-PE can be tolerated. For this part, the study is recruiting adult patients with various types of cancer. After six participants have taken the lowest dose with no more than one experiencing dose-limiting toxicity, two participants may begin the study taking the medium dose. If they tolerate the medium dose for a month, up to four more may begin at that dose. When at least three participants have tolerated the medium dose, two may attempt the highest dose. When they have tolerated the highest dose for one monthly cycle, 1-4 more may begin the study, receiving the highest dose.
  Adrenal cortex cancer (ACC) is a rare tumor in the gland above the kidney. It affects only 1-2 people per million each year and causes hormone problems. This tumor affects children under age 5 and adults aged 30-40, causing death within five years for up to 80% of them. During the second part of the study, all participants will be ACC patients. They will receive the highest dose tolerated during Part 1 on days 1, 3, and 5 of each monthly cycle for up to four months.


Eligibility: Inclusion Criteria:
  -  Has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria at presentation
  -  Has failed standard treatment
  -  Has met protocol-specified criteria for qualification and contraception
  -  Has voluntarily consented to participate and provided written informed consent prior to any protocol-specific procedures
  Exclusion Criteria:
  -  Has history or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
  -  Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
  -  the safety or well-being of the participant or study staff
  -  the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  -  the analysis of results

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 Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer

Summary: This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.


Eligibility: Inclusion Criteria:
  -  Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).
  -  Evidence of T790M mutation to enroll in Cohort A.
  -  Evidence of measurable disease by radiographic technique.
  -  Adequate organ function.
  Exclusion Criteria:
  -  Patients with T790M mutation who stopped any prior EGFR-directed therapy without evidence of disease progression.
  -  Symptomatic brain metastases.
  -  Uncontrolled or significant cardiovascular disease.
  -  Pregnant or breastfeeding.

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 in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation

Summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult patient, >/= 18 years of age
  -  Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
  -  No prior treatment for unresectable Stage IIIB or IV NSCLC
  -  Measurable radiographic evidence of disease according to RECIST v1.1
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  Exclusion Criteria:
  -  Prior exposure to agents targeting either the Hepatocyte Growth Factor (HGF) or MET pathway
  -  Exposure to an investigational or marketed agent that can act by EGFR inhibition
  -  Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
  -  Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for >/=4 days. Note: Patients with treated CNS metastases who are asymptomatic and on a stable dose of corticosteroids for >/= 14 days prior to randomization are eligible.
  -  History of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease-free
  -  Radiographically evident interstitial lung disease , concurrent infection, or a history of any of these conditions
  -  Inadequate hematologic, biochemical, and organ function
  -  Pregnant or lactating women
  -  Life expectancy of < 12 weeks
  -  Receipt of an investigational drug within 28 days prior to initiation of study treatment

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

Clinical trial: VEGFRs Predict Bevacizumab Benefit in Advanced Non Small Cell Lung Cancer

Summary: a. VEGFRs may be the biomarker which can predict the effect of bevacizumab in non small cell lung cancer

Detailed description: 1. non small cell lung cancer (non squamous carcinoma)
  2. ECOG 0-1
  3. from 18-75 years old

Eligibility: Inclusion Criteria:
  -  non squamous cell non small cell lung cancer
  -  with measurable disease
  -  ECOG 0-1
  Exclusion Criteria:
  - patients received surgery in recent 4 weeks

Relevance to patient case: not relevant