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

Clinical trial: Comparative Study of Chemoradiation and Sequential Chemoradiation About Lung Adenocarcinoma Patients With Postoperative in pN2

Summary: The purpose of this study compares chemoradiation and sequential chemoradiation about Lung adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic method is better for the patients.


Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of Lung adenocarcinoma
  -  Postoperative staging pN2 period
  -  Voluntary participation and informed consent
  -  Age ≥ 18 years old, male or female, within six months of weight loss of less than 10%, can tolerate radiotherapy
  -  performance status( PS) score 0-2.
  -  Hemoglobin ≥ 80 g / L, white blood cell ≥ 4 × 109 / L, platelets ≥ 100 × 109 / L.
  -  Liver function: alanine aminotransferase (ALAT), aspartate transaminase (ASAT) <upper limit of normal (ULN) of 1.5 times, bilirubin <1.5 × ULN.
  -  Renal function: serum creatinine <1.5 × ULN.
  -  Compliance, and can be regular follow-up, voluntary compliance with study requirements
  Exclusion Criteria:
  -  Do not meet the inclusion criteria
  -  There is evidence of distant metastases
  -  Suffered from other malignancies in five years
  -  Within the past January subjects received other drug trials
  -  Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
  -  Severe lung or heart disease, a history
  -  Refuses or is unable to sign informed consent to participate in trials
  -  The abuse of drugs or alcohol addicts.
  -  Patients with difficult to control bacterial, viral, fungal infections
  -  Having a personality or mental disorders, without civil capacity or restricted civil capacity.
  -  Being pregnant or lactating women.

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 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer

Summary: This is a Phase 3, multicenter, randomized, double-blind, placebo controlled study of Rilotumumab (AMG 102) with Cisplatin and Capecitabine (CX) for untreated advanced mesenchymal epithelial transition factor (MET)-positive gastric or gastroesophageal junction adenocarcinoma (GEJ).


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).
  -  Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
  -  Male or female subject greater than or equal to 20 years of age at the time of informed consent.
  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 or lower esophageal adenocarcinoma.
  -  Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to randomization.
  -  Squamous cell histology.

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 1/1b Study of MGCD516 in Patients With Advanced Cancer

Summary: MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles.
  During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations.
  Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.

Detailed description: During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed.
  During the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon the following cancer diagnosis:
  Non-small cell lung cancer with genetic alterations in MET, AXL, RET, TRK, DDR2, KDR, PDGFRA, KIT or CBL.
  Head and neck squamous cell carcinoma with genetic alterations in MET.
  Clear cell renal cell carcinoma refractory to angiogenesis inhibitors.
  Metastatic prostate cancer with bone metastases.
  Other cancer diagnosis having a selected genetic alteration in MGCD516 target RTKs.

Eligibility: Inclusion Criteria:
  -  Metastatic or unresectable solid tumor malignancy
  -  Standard treatment is not available
  -  Adequate bone marrow and organ function
  Exclusion Criteria:
  -  History of a significant cardiovascular illness
  -  Prolonged corrected QT (QTc) interval
  -  Left ventricular ejection fraction < 40%
  -  Symptomatic or uncontrolled brain metastases
  -  Other active cancer

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

Clinical trial: A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer

Summary: To investigate the anti-tumor activity of single agent BYL719, INC280, LDK378 and MEK162


Eligibility: Inclusion Criteria:
  -  Advanced (stage IIIB or stage IV) NSCLC
  -  Must have specific molecular alterations
  Exclusion Criteria:
  -  Symptomatic central nervous system (CNS) metastases which are neurologically unstable or requiring increasing doses of steroids within the 4 weeks prior to study entry to control their CNS disease
  -  Radiation therapy within ≤ 4 weeks prior to study entry, with the exception of limited field palliative radiotherapy for bone pain relief.
  -  Any other malignancies within the last 5 years before study entry
  -  Major surgery ≤ 2 weeks prior to study entry or who have not recovered from side effects of such therapy
  Other protocol-defined inclusion/exclusion 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: Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With EGFR Gene Mutation

Summary: This is a randomized ,opened, prospective controlled trial of clinical effectiveness for Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma patients with epidermal growth factor receptor gene mutation

Detailed description: In this trial the investigators will enlist 100 patients who accepted surgery and with epidermal growth factor receptor gene mutation,these patients will be divided into 2 groups (chemotherapy group and Icotinib group),compare the PFS,RFS,OS after 5 years follow up

Eligibility: Inclusion Criteria:
  -  18-75 years old
  -  Lung adenocarcinoma patients with epidermal growth factor receptor gene mutation,stage I-IIIB after surgery
  -  The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2
  Exclusion Criteria:
  -  Mismatch conditions above
  -  Have used other anti-cancer therapy drug before the trial and may influence the outcome

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

Clinical trial: An epidemiOlogy Study to deteRmine the Prevalence of EGFR (Epidermal Growth Factor Receptor) muTations in RUSsian Patients With Advanced NSCLC (Non-Small Cell Lung Cancer).

Summary: This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia.

Detailed description: This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
  It is planned to enrol approximately 300 subjects in Russian Federation. Approximately 60 EGFR m+ (mutation-positive) patients will be followed for 1.5 years.
  EGFR mutations rate before treatment in cytology and plasma samples in treatment-naive patients with advanced NSCLC in Russia is considered as the primary outcome variable in this study.

Eligibility: Inclusion Criteria:
  -  Cytologically verified advanced (stages IIIB - IV) nonsquamous (adenocarcinoma, large cell carcinoma) and mixed subtypes of NSCLC and NSCLC-NOS), diagnosed before enrolment into the study
  -  Quality and quantity of the cytological sample material meeting the requirements of the molecular-genetic testing
  -  No previous/ ongoing treatment for NSCLC at the moment of recruitment
  Exclusion Criteria:
  -  Squamous NSCLC cytologically confirmed subtype of cancer
  -  Any medical condition which on the opinion of the investigator may interfere the patient's participation in the study
  -  Quality and quantity of the cytological sample material insufficient for the molecular-genetic testing

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

Clinical trial: Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema

Summary: The main objective of this trial is to evaluate the prevalence of alpha-1 antitrypsin quantitative and functional deficiency in an adult French population presenting with pulmonary emphysema. Phenotypic and genotypic studies will be carried whenever quantitative and/or functional deficiency will be displayed.


Eligibility: Inclusion Criteria:
  -  Pulmonary emphysema highlighted by computed tomography
  -  Ratio Forced Expiratory Volume in 1 second (FEV1) / Vital Capacity (VC) < 70% measured by lung function test
  Exclusion Criteria:
  -  Hepatic transplant
  -  Patient under legal protection
  -  Patient not benefiting from the French Health Insurance

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

Clinical trial: Clinical Trial of Erlotinib and Pemetrexed for Maintenance Treatment in Lung Adenocarcinoma

Summary: The purpose of this study is to compare effects of erlotinib and pemetrexed as maintenance therapy for lung adenocarcinoma. Primary Outcome is the progression free survival (PFS). Based on prediction of different potential benefit groups, this study may help the oncologist to optimize and improve the maintenance therapy plan for lung adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically diagnosed stage III/IV Lung Adenocarcinoma;
  -  Age of 18-75years; Gender Not Required;
  -  Received systemic clinical examination, including chest X-ray, abdomen B ultrasound, head CT scan, radionuclide bone scan;
  -  Received cisplatin chemotherapy for 4 cycles before this study, the curative effect of chemotherapy is SD or above SD (efficacy evaluation time is 21 days, if it is SD, then the longest diameter of target lesions shall not increase);
  -  Adequate hematologic, renal, and hepatic function, Specific index as follows: liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l, Hb≥100 g/l;
  -  ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;
  -  The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);
  -  No history of serious drug allergy;
  -  Informed consent should be obtained before treatment.
  Exclusion Criteria:
  -  Not histologically or cytologically diagnosed as Lung Adenocarcinoma
  -  The age of >75 years or <18 years.
  -  Major organ dysfunction and Serious Heart Disease (congestive heart-failure, incontrollable high-risk arrhythmia, unstable angina, alular disease, myocardial infarct and Resistant hypertension,);
  -  Serious complications and investigator consider it is unsuited enrolling;
  -  Pregnant or lactating women;
  -  Allergic to research drug;
  -  Received cisplatin chemotherapy for 4 cycles before this study, the curative effect of chemotherapy is PD

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 Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy

Summary: This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second line therapy.
  4. c-MET positive gastric cancer
  5. ECOG PS 0-2
  6. At least one measurable disease
  7. Proper organ function
  Exclusion Criteria:
  1. severe co-morbid illness and/or active infections
  2. pregnant or lactating women
  3. History of documented congestive heart failure; angina pectoris requiring medication; evidence of tranasmural myocardial infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; or high risk of uncontrollable arrhythmia
  4. active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
  5. known history of hypersensitivity to study drugs

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

Clinical trial: Genetics of the Combined Pulmonary Fibrosis and Emphysema Syndrome

Summary: The combined pulmonary fibrosis and emphysema syndrome (CPFE) individualized by our group in 2005 is characterized by an often severe dyspnea, almost exclusive male predominance, and often major, profound impairment of gas exchange contrasting with preserved lung volumes and absence of airflow obstruction, and a high risk of pre-capillary pulmonary hypertension responsible for increased mortality. Almost all patients are smokers or ex-smokers. There are some arguments in favor of genetic abnormalities in this syndrome of unknown etiology (other than smoking) including short telomeres and mutations in the telomerase complex genes. There are also emphysematous lesions, in patients with familial pulmonary fibrosis, with mutations in the SFTPC gene (surfactant protein C), and reported cases of CPFE syndrome with SFTPC mutation. No large genetic studies have been conducted to date in the CPFE syndrome. Our main hypothesis is that the proportion of subjects with short telomeres is higher among patients with CPFE syndrome than in subjects of similar age with idiopathic pulmonary fibrosis but without emphysema. It has previously been shown that mutations in the telomerase TERT or TERC genes are mostly found in people whose telomeres are abnormally short. The investigators propose to use that test to identify patients most likely carrying a mutation, and to seek, among them, the mutations in the TERT or TERC telomerase genes. The objective of the study is to compare the proportion of patients with short telomeres in the group of patients with CPFE syndrome to that of other patients (with idiopathic pulmonary fibrosis without emphysema, or with emphysema without fibrosis).


Eligibility: Inclusion Criteria:
  -  Age between 18 and 80 years old.
  -  Patient with Idiopathic Pulmonary Fibrosis Or
  -  Patient with emphysema Or
  -  Patient with combined pulmonary fibrosis and emphysema syndrome Or
  -  Patient reporting no chronic lung disease
  Exclusion Criteria:
  -  Other causes of interstitial lung disease or context:
  -  Connective
  -  Pneumonia drug
  -  Pneumoconiosis
  -  Sarcoidosis
  -  histiocytosis, lymphangioleiomyomatosis, etc.
  -  Refusal to participate in the study or to sign the consent
  -  Inability to give informed about the information
  -  Woman breastfeeding or pregnant
  -  No coverage for Social Security
  -  Deprivation of Civil Rights

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 II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung

Summary: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

Detailed description: This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).

Eligibility: Inclusion Criteria:
  -  Age: at least 20 years of age
  -  Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy
  -  Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI
  -  At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q)
  -  World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months
  -  Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen
  -  At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per RECIST version 1.1
  -  Adequate hematological and biological function
  -  Females of child-bearing potential must agree to use adequate contraception and for 3 months after the last dose of study drug
  -  Male patients should be documented to be sterile or agree to use barrier contraception
  -  Recovery to ≤ Grade 1 or baseline of any toxicities, except for stable sensory neuropathy ≤ Grade 2 and alopecia
  Exclusion Criteria:
  -  Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713
  -  Previous treatment with anticancer therapies, EGFR-TKI, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy
  -  Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
  -  Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
  -  History of any other malignancy
  -  Clinically significant uncontrolled condition(s)
  -  Active or chronic pancreatitis
  -  Anyone with cardiac abnormalities or history
  -  Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis
  -  Pregnant or breast feeding
  -  In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713

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

Clinical trial: The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR

Summary: The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced lung adenocarcinoma patients with wild-type EGFR

Detailed description: 400 patients with stage IIIB & IV lung adenocarcinoma who had received surgery and chemotherapy,will be randomly divided into group A（Apatinib plus CIK treatment ) or group B（Apatinib), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed Lung adenocarcinoma
  -  Wld-type EGFR
  -  Stage IIIB/IV
  -  Failure to prior chemotherapy
  -  Life expectancy of more than 3 months
  -  Tissue sample desired for genomic study
  -  Age ≥ 18 years
  -  Performance status (WHO) < 3
  -  Adequate bone marrow function (absolute neutrophil count>1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
  -  Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
  -  Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
  -  Informed consent
  Exclusion Criteria:
  -  Lung squamous cell carcinoma or other types of Non-Small cell lung cancer
  -  Small cell lung cancer
  -  Have previously received TKIs
  -  Hemoglobin＜8.0 g/dL,White blood cell ＜3 X 10^9/L;Platelet count ＜75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
  -  Known or suspected allergy to the investigational agent or any agent given in association with this trial
  -  Pregnant or lactating patients
  -  Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
  -  Patients who are suffering from serious autoimmune disease
  -  Patients who had used long time or are using immunosuppressant
  -  Patients who had active infection
  -  Patients who are suffering from serious organ dysfunction
  -  Patients who are suffering from other cancer
  -  Other situations that the researchers considered unsuitable for this study.
  -  Other concurrent uncontrolled illness

Relevance to patient case: not relevant