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

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

Clinical trial: Comparison of cVATS Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion

Summary: This is a Prospective, open-label, parallel, multi-center, Phase III randomized trial to evaluate the efficacy and safety of video-assisted thoracoscopic segmentectomy versus Lobectomy in treating patients with Lung adenocarcinoma in situ or with microinvasion.

Detailed description: Lobectomy has long been considered the standard procedure for early-stage lung cancer, and minimally invasive techniques have been demonstrated to be associated with superior outcomes compared with lobectomy by thoracotomy. the us of segmentectomy is under investigation for selected patients with small tumors, and the use of minimally invasive strategies is applicable as well.
  This nationwide, multicenter, prospective, randomized open phase III study of cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy versus Lobectomy for stage IA non-small cell lung cancer (NSCLC) patients with Lung adenocarcinoma in situ or with microinvasion, is aiming to evaluate the relapse free survival and 5 year overall survival (OS) rate of two types of surgery. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients undergo cVATS lobectomy.
  -  Arm II: Patients undergo cVATS segmentectomy.
  Patients will be followed up every 3 months within the first year, and annually for 5 years postoperatively.

Eligibility: Inclusion Criteria:
  Preoperative criteria: peripheral non-small cell lung cancer, no larger than 2 cm in maximal diameter, no lymph node metastasis, FEV1%>50% (FEV1: Forced Expiratory Volume in 1 second);
  Preoperative imaging:pure ground-glass or mixed ground-glass nodules (part-solid, solid areas < 0.5cm);
  Follow-up duration last 3 months or more, HRCT (HRCT: high-resolution computed tomography) lesion maximum diameter was measured three times and took the average, meet the criteria of clinical surgical indications;
  Intraoperative criteria: histologically confirmed NSCLC, adenocarcinoma in situ or with microinvasion;
  No prior ipsilateral thoracotomy;
  No prior anti-neoplastic therapy;
  EOCG Performance status 0-2;
  Sufficient organ functions;
  Written informed consent.
  Exclusion Criteria:
  Active bacterial or fungous infection;
  Simultaneous or prior (within the past 5 years) other malignant disease;
  Interstitial pneumonitis, pulmonary fibrosis, or severe COPD (COPD: chronic obstructive pulmonary disease);
  Abnormal Psychosis;
  Uncontrollable diabetes mellitus;
  History of severe cardiovascular disease;
  Any condition which, in the opinion of the investigator might interfere with the evaluation of the objective.

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

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

Clinical trial: To Improve Lung Function and Symptoms for Emphysema Patients Using Zephyr EBV

Summary: To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema patients in a controlled trial design setting.


Eligibility: Inclusion Criteria:
  -  Heterogeneous emphysema
  -  15% pred < or = FEV1 < or = 45% pred
  -  TLC > 100% and RV > or = 180%
  -  150 m < or = 6MWT < or = 450 m
  -  No collateral ventilation
  Exclusion Criteria:
  -  Contraindication to bronchoscopy
  -  Active pulmonary infection
  -  History of 2 or more exacerbations with hospitalization over the past 12 months
  -  Known pulmonary hypertension
  -  Prior LVR or LVRS procedure
  -  Pregnant or lactating woman
  -  Hypercapnia
  -  Current diagnosis of asthma
  -  > 25 mg Prednisolon / day
  -  CV in the target lobe or inconclusive Chartis assessment

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

Clinical trial: Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study

Summary: The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in patients suffering from COPD with Homogeneous Emphysema. Patients will be followed up for 12 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm after the 6-month visit and will be followed up for 6 additional months.The primary objective is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index) changes, target lobe volume reduction, as well as safety outcomes.


Eligibility: Inclusion Criteria:
  -  Homogeneous emphysema
  -  15% < or = FEV1 < or = 45% predicted
  -  TLC > 100% predicted
  -  RV > or = 200% predicted
  -  6-MWT > or = 150 m
  -  Non-smoker > 8 weeks prior to study entry
  -  Absence of Collateral Ventilation in the target lobe
  Exclusion Criteria:
  -  Active pulmonary infection
  -  More than 3 exacerbations with hospitalizations over the past 12 months
  -  Pulmonary hypertension (sPAP > 45 mmHg)
  -  MI or other relevant CV events in the past 6 months
  -  Alpha-1 antitrypsin deficiency
  -  Bronchiectasis
  -  Prior LVR or LVRS procedure
  -  > 20% difference in perfusion between right and left lung
  -  Hypercapnia (paCO2 > 55 mmHg
  -  Asthma
  -  Use of more than 25 mg/day prednisolone or equivalent
  -  Severe bullous emphysema
  -  Systemic or malignant disease with high death probability within 12 months

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 Epidemiologic Study of ALK-Positive NSCLC in China

Summary: This is a post-marketing, observational, non-interventional, multi-central study of patients with non-small cell lung cancer (NSCLC), with data collected prospectively from medical records at inclusion. The primary objective is to obtain the epidemiologic data of anaplastic lymphoma kinase (ALK)-positive in unselected Chinese patients with NSCLC.

Detailed description: Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the Department of Pathology. ALK positive status will be detected by Ventana immunohistochemistry (IHC) (Ventana Medical Systems, Inc. and Roche Diagnostics International, Inc). When ALK positive patients are detected, crizotinib will be administrated by various solutions based on physician's desecration and patients' willingness.
  The secondary objectives include: 1.To obtain the epidemiologic data of ALK positive in unselected Chinese patients with NSCLC.2.To describe demographic, socioeconomic [such as age, gender, race/ethnicity, geographic location (including rural/urban area), pathologic parameters, education, family income, National Reimbursement Drug List (NRDL) or Provincial Reimbursement List (PRDL)], and clinical characteristics of NSCLC patients with ALK positive.
  The exploratory objective is to describe prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally.

Eligibility: Inclusion Criteria:
  -  Adult patients (≥18 years), both sex.
  -  Histologically or cytologically proven diagnosis of primary NSCLC, including squamous cell carcinoma and adenocarcinoma.
  -  Written informed consent.
  Exclusion Criteria:
  -  Those lung cancers without pathological diagnosis should not be included in case of other types of cancer, including small cell lung cancer (SCLC) or metastatic disease from other organs.

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 Examining Maintenance Avastin Monotherapy in Patients With Advanced Lung Adenocarcinoma

Summary: This is a prospective, open-label, single arm, non-interventional study will investigate the effectiveness of Avastin monotherapy for patients with lung adenocarcinoma who previously received 4 to 6 cycles of induction platinum doublet plus Avastin. The study is expected to last approximately 28 months.


Eligibility: Inclusion Criteria:
  -  18 years or older
  -  Patients who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab
  -  Patients who received only 1 cycle of bevacizumab maintenance treatment
  -  meet summary of product characteristics guidelines
  Exclusion Criteria:
  -  Patients who received the first cycle of maintenance bevacizumab more than 4 weeks after the postinduction tumor assessment
  -  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: Erlotinib Combined With Chemotherapy in TKI Resistant Non-Small Cell Lung Cancers

Summary: Numerous evidences verified that erlotinib could dramatically improve the PFS and OS of non-small cell lung cancers who harbor EGFR sensitive mutations, however, primary or secondary resistance will be developed after TKI treatment, doctors do plenty of researches to overcome TKI resistance. FAST ACT-2 study present that, first line erlotinib combined with chemotherapy could improved mOS to more than 30 months in NSCLCs who harbor EGFR sensitive mutations, several study shows that sensitive mutations still exist after TKI resistance, because of the next generation TKIs(such as BIBW2992) are not avaliable at present, agents for met amplification(such as Crizotinib) are so expensive that many Chinese patients could not support. Thus, the investigators hypothesis that, after first line TKI treatment, the patients who developed TKI resistance could still benefit from second line TKI combined with chemotherapy.

Detailed description: The investigators will enroll patients diagnosed with advanced non-squamous,non-small cell lung cancer, patients with EGFR TKI sensitive mutations and developed TKI resistance in first line treatment. After enrollment, the investigators will do biopsy again before second line treatment to find out the potential mechanism of TKI resistance, do EGFR mutation test for both sensitive and resistant mutation in exon 18, 19, 20 and 21; do KRAS, BRAF and PI3K mutation test, do FISH for MET and HER-2, the investigators do all these test to evaluated both primary and secondary resistance, the investigators do all these tests to get an overview for EGFR mutation status of each patient who develop TKI resistance. For second line treatment, patients will received a 28 days gemcitabine platinum combined with erlotinib scheme, after 4 cycle of combined chemotherapy, patients will receive erlotinib for further treatment until progression disease. For the patients who have stable brain metastases, combined chemotherapy should begin after local treatment, such as whole brain radiotherapy or sterotactic radiosurgery.
  the main endpoint of this study is mean PFS, second endpoints of this study consist of mean OS, 8 week ORR.

Eligibility: Inclusion Criteria:
  -  advanced non-small cell lung cancer, stage IIIB/IV
  -  non-squamous
  -  EGFR sensitive mutations, such as exon 19 del, or exon 21 L858R
  -  received first line TKIs treatment and developed TKI resistance
  -  ECOG 0-2
  Exclusion Criteria:
  -  squamous non-small cell lung cancer
  -  patients have unstable brain metastasis, predict survival less than 8 weeks
  -  spinal-cord compression without evidence of stabilisation or treatment
  -  women who were pregnant or lactating; women with a positive or no available pregnancy test result at baseline
  -  patients have any unstable illness that could not receive further treatment

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

Clinical trial: Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma

Summary: This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.


Eligibility: Inclusion Criteria:
  -  Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT)
  -  Patients must have previously untreated locally advanced or metastatic NSCLC
  -  EGFR activating mutation (exon 19 deletion, L858R) is required
  -  Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
  Exclusion Criteria:
  -  Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR
  -  Patients with wild-type EGFR
  -  Any other investigational agents are not permitted
  -  Any evidence of interstitial lung disease

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

Clinical trial: c-Met Second-Line Hepatocellular Carcinoma

Summary: This is a Phase 1b/2, multicenter, single arm trial to assess the efficacy, safety, and pharmacokinetics (PK) of MSC2156119J as monotherapy in subjects with MET+ advanced hepatocellular carcinoma (HCC) with child Pugh Class A liver function who have failed sorafenib treatment.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed HCC
  -  Child Pugh Class A liver function score
  -  For Phase 2 only: MET+ status
  -  Male or female, 18 years of age or older
  -  Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (inclusive)
  -  Availability of a pretreatment tumor biopsy (excluding fine needle aspiration and cytology samples) taken after the subject has discontinued sorafenib and within 28 days before the day of first dosing with MSC2156119J. From the pretreatment biopsy either a formalin-fixed (formalin fixation is mandatory) paraffin-embedded block with tumor tissue (preferred) or at least 15 unstained slides must be sent to the central laboratory prior to enrollment. An associated pathology report must also be sent with the sample
  -  Previously treated with sorafenib for greater than or equal to 4 weeks and discontinued sorafenib treatment at least 14 days prior to Day 1 due to either intolerance or radiographic progression
  -  Signed and dated informed consent indicating that the subject (or legally acceptable representative if applicable by local laws) has been informed of all the pertinent aspects of the trial prior to enrollment
  -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures
  -  Life expectancy of at least 3 months as judged by the investigator
  Exclusion Criteria:
  -  Prior systemic anticancer treatment for advanced HCC (except for sorafenib as described in the inclusion criteria)
  -  Prior treatment with any agent targeting the hepatocyte growth factor (HGF)/c-Met pathway
  -  Local-regional therapy within 4 weeks before Day 1
  -  Impaired cardiac function
  -  Other protocol defined exclusion criteria could apply

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

Clinical trial: Registry Measuring the Impact of Adding RNA Expression Testing on Referral Decisions in Early Stage Lung Cancer Patients and Assessing the Disease-free Survival With Long-term Follow-up

Summary: This registry is intended to measure the effect of myPlan Lung Cancer™ test has on treatment decisions of Surgeons when added to standard clinical-pathological parameters in patients with early stage NSCLC.The sponsor is conducting two parallel registries, with one directed at Surgeons (ONC003) and the other at Oncologists (ONC006).This registry is specific to Surgeons (ONC003). Outcomes measures on lung cancer relapse and death from any cause will be collected.


Eligibility: Inclusion Criteria:
  -  Diagnosis of early stage non-small cell lung adenocarcinoma
  -  Sub-population staging (IA, IB or IIA) as judged by the standard of practice at the investigational site
  -  Resection of tumor within previous 2 months of enrollment
  -  ECOG performance of 0-2
  -  A minimum life expectancy of six months
  Exclusion Criteria:
  -  Pre-operative radiation or chemotherapy for NSCLC
  -  Post-operative radiation or chemotherapy for NSCLC
  -  Enrollment in a separate clinical trial restricting treatment options
  -  Unable to provide informed consent

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

Clinical trial: Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma

Summary: The purpose of this study is to compare 2 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Detailed description: This study is designed to compare 2 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
  Primary Outcome Measure:
  Disease-free survival between Icotinib group and placebo group.
  Secondary Outcome Measures:
  Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.

Eligibility: Inclusion Criteria:
  -  Pathologically confirmed lung adenocarcinoma after surgical resection
  -  Stage II-IIIA disease according to 7th edition of TNM staging
  -  Patients must harbor sensitive EGFR gene mutation (19/21)
  -  Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy
  Exclusion Criteria:
  -  Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
  -  Presence of metastatic disease
  -  Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  -  Any unresolved chronic toxicity from previous anticancer therapy
  -  Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)

Relevance to patient case: not relevant