araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Study of Proteins in Tumor Samples From Patients With Non-Small Cell Lung Cancer

Summary: This research studies protein in tumor samples from patients with non-small cell lung cancer. Finding specific proteins in tumor tissue samples from patients with cancer may help doctors tell what type of lung cancer a patient has and plan better treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. To validate a novel 4-protein signature's ability to subtype non-small cell lung cancer (NSCLC) in a treatment-naive, multi-institutional cohort, Cancer and Leukemia Group B (CALGB) 9761.
  SECONDARY OBJECTIVES:
  I. To estimate the NSCLC misclassification rate in a multi-institutional clinical-trial setting for stage 1 NSCLC (adenocarcinoma versus squamous cell).
  OUTLINE:
  Previously collected tissue samples are analyzed via hematoxylin and eosin (H&E) staining and immunohistochemistry (IHC).

Eligibility: Inclusion Criteria:
  -  Patients must have been registered on CALGB-9761
  -  Stage I disease
  -  Treatment-naive patients
  -  A representative paraffin block of the primary tumor must be available from patients on CALGB-9761 and submitted to the CALGB Pathology Coordinating Office
  -  A separate consent form is not required for this study, as permission for research to be performed on the tissue blocks is included in the consent form for CALGB 9761
  -  Institutional review board (IRB) review and approval at the institution where the laboratory work will be performed is required

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema

Summary: The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality of life, exercise capacity, and static lung volumes, in patients with emphysema. The mechanism of action for these effects is believed to be related to the restoration of elastic recoil to lung parenchyma that has been damaged by emphysema. The objective of this study is to evaluate several physiologic parameters which should provide measures directly related to the mechanism of action by which the coils produce these outcomes.


Eligibility: Inclusion Criteria:
  Subject > 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form
  Exclusion Criteria:
  Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

Summary: The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.

Detailed description: The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced homogeneous or heterogeneous emphysema.

Eligibility: Inclusion Criteria:
  -  Confirmation of completion of Aeris' post market follow-up Continuation Study, 03-C10-001PLV.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)

Summary: This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult participants, greater than or equal to (>/=) 18 years of age
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  -  Histologically or cytologically confirmed incurable Stage IIIb/IV NSCLC tumor
  -  Met diagnostic-positive status tested by immunohistochemistry (IHC)
  -  Results of endothelial growth factor receptor (EGFR)-activating mutation testing
  -  Radiographic evidence of disease
  -  Prior treatment with at least one platinum-based line of treatment (for stage IIIb/IV) and no more than one additional line of chemotherapy treatment; the last dose of chemotherapy must have been administered >/= 21 days prior to Day 1
  -  availability of tissue sample for diagnostic testing is required
  Exclusion Criteria:
  -  More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known EGFR-related toxicity resulting in dose modifications (EGFR inhibitors including but not limited to gefitinib, erlotinib and cetuximab)
  -  Brain metastases or spinal cord compression not definitively treated with surgery and/or radiation, or previously treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease for >/= 14 days
  -  History of another malignancy in the previous 3 years, unless cured by surgery alone and continuously disease free for at least 3 years; participants with prior history of non-invasive cancers are eligible
  -  Inadequate hematological, biochemical or organ function
  -  Significant history of cardiac disease
  -  Serious active infection at time of randomization or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment
  -  Any inflammatory changes of the surface of the eye
  -  Clinically significant gastro-intestinal disease, including uncontrolled inflammatory gastro-intestinal diseases
  -  Pregnant or lactating women
  -  Positive for human immunodefinciency (HIV) infection

Relevance to patient case: possibly relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer

Summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.

Detailed description: A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.

Eligibility: Inclusion Criteria:
  -  Female or male aged 25 or over
  -  Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro oesophageal junction )
  -  Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy.
  -  At least one lesion, not previously irradiated, that has baseline at least 10mm in the longest diameter for non nodal lesions and is assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI)
  -  Provision of either an archival tumour sample or a fresh tumour sample for confirmation of FGFR2 polysomy/gene amplification
  Exclusion Criteria:
  -  Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in cremophor EL (polyoxyethylated castor oil)
  -  Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant therapy given > 6 months; Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment
  -  With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at the time of starting study treatment.
  -  Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.
  -  Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Study of ABT-700 in Subjects With Advanced Solid Tumors

Summary: This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications, is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.


Eligibility: Inclusion Criteria:
  -  Subject with advanced solid tumors; Dose-expansion: evidence for MET gene amplification.
  -  Subject must have disease: a) that is not amenable to surgical resection, or b) that has progressed or recurred despite standard therapy, or c) that has failed to respond to standard therapy, or d) for which no effective therapy exists.
  -  Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage.
  -  Subjects enrolled on the combination therapy phase must satisfy the above inclusion criteria and also the following: Subjects must have inoperable, locally advanced or metastatic cancer and be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib in combination with ABT-700.
  Exclusion Criteria:
  -  Subject has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of ABT-700.
  -  Subjects with uncontrolled metastases of the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease after definitive therapy and have not used steroids for at least 1 month prior to first dose of ABT-700.
  -  Subject has unresolved adverse events > Grade 1 from prior anticancer therapy except for alopecia or anemia.
  -  Subject has had major surgery within 21 days prior to the first dose of ABT-700.
  -  Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib per most current prescribing information, or at the discretion of the Investigator. Subjects with K-Ras mutation-positive colorectal cancer will be excluded from receiving FOLFIRI/cetuximab.

Relevance to patient case: possibly relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy

Summary: to determine the values of imaging and genetic biomarkers for prediction of tumor aggressiveness and prognosis in patient with early stage lung adenocarcinoma to Identify unique copy number alteration in patient with early stage lung adenocarcinoma to evaluate the long-term change of ground-glass nodule combined with lung adenocarcinoma to suggest a guideline for planning an appropriate follow-up examination and management


Eligibility: Inclusion Criteria:
  -  A. Clinically and radiologically suspected lung adenocarcinoma
  -  B. Newly-diagnosed Stage I or II from the clinical work up including PET/CT
  -  C. Performance status of 0 to 1 on the ECOG scale
  -  D. Age 20 years or older
  -  E. Able to tolerable DECT imaging required by protocol
  -  F. Able to give study-specific informed consent
  Exclusion Criteria:
  -  A. Prior malignancy
  -  B. planning of Definitive RTx 나 neoadjuvant CCRTx
  -  C. Poor cardiopulmonary reserve

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

Summary: MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch of Douglas. The investigators think that the localization of the rectal tumor in function of this anatomic mark could be decisive for pre-operative assessment.


Eligibility: Inclusion Criteria:
  -  Rectal adenocarcinoma
  Exclusion Criteria:
  -  Metastatic disease
  -  under 18y patient
  -  woman of childbearing age

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

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: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Post Market Registry Study of the AeriSeal System

Summary: -  Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting;
  -  Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of AeriSeal System treatment.


Eligibility: Inclusion Criteria:
  -  Advanced Emphysema
  -  AeriSeal System treatment
  Exclusion Criteria:
  -  have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis
  -  have had frequent COPD exacerbations within the past year
  -  require mechanical ventilatory support
  -  have a pretreatment DLCO < 20% predicted or > 60% predicted
  -  have a pretreatment FEV1 < 20% predicted AND homogeneous emphysema
  -  have giant bullae
  -  have undergone lung transplantation, lung volume reduction surgery, or lobectomy
  -  are intolerant of corticosteroids or antibiotics
  -  are pregnant or breast-feeding

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

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: possibly relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.

Summary: The purpose of this trial is to compare the evolution of patients receiving first line treatment for locally advanced or metastatic lung cancer, taking into account if they were requested or not the EGFR mutation test as part of the diagnosis and treatment strategy. There is no assignment to any particular therapeutic strategy.

Detailed description: Study of cases and controls on diagnosis and treatment strategies in patients with NSCLC with or without EGFR mutations.

Eligibility: Inclusion Criteria:
  -  Patients with confirmed diagnosis of lung adenocarcinoma, stage IIIb/IV.
  -  Patients under 1st line treatment against lung adenocarcinoma.
  Exclusion Criteria:
  -  Patients not having the information required by the protocol.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors

Summary: INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280


Eligibility: Inclusion Criteria:
  -  Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available.
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  -  Good organ (hepatic, kidney, BM) function at screening/baseline visit.
  Exclusion criteria:
  -  Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
  -  Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC280.
  -  Undergone a bone marrow or solid organ transplant.
  -  Women who are pregnant or breast feeding.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant