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

Clinical trial: PET/CT Imaging of Angiogenesis in Lung or Head and Neck Cancers Prior or During Chemotherapy With Antiangiogenic Agents

Summary: The primary objective of this Phase II study is to evaluate the use of labelled RGD ligand in PET/CT to predict and/or to early assess the efficacy of chemotherapy including an agent with antiangiogenic effect.
  The predictive value of this approach will be determined by independent assessors on basis of data at the end of the treatment: RECIST 1.1 criteria for CT or MRI, PERCIST criteria for FDG PET/CT, clinical, endoscopic and histological findings.

Detailed description: Prospective, multicentre, open label, phase II clinical trial with diagnostic radiopharmaceutical on efficacy and tolerability of 18F or 68Ga labelled RGD peptide for detection of malignant tissues expressing integrins, to predict the therapeutic response of lesions of advanced head and neck cancer or advanced non-small cells lung cancer to treatment including an agent with antiangiogenic effect.

Eligibility: Inclusion Criteria:
  -  1A. Male or female > 18year old with non-small cell lung carcinoma (NSCLC) meeting the following criteria :
  -  advanced NSCLC proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled
  -  Measurable lesions > 1 cm in short axis.
  -  Pretherapeutic contrast-enhanced CT of thorax and upper abdomen available for masked reading on appropriate medium
  -  FDG PET/CT available for masked reading on appropriate medium
  1B. Male or female > 18year old with head and neck (H&N) cancer meeting the following criteria:
  -  advanced H&N cancer proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled
  -  Measurable lesions > 1 cm in short axis.
  -  Pretherapeutic native and contrast enhanced CT or MRI of the head and neck available for masked reading on appropriate medium
  -  FDG PET/CT available for masked reading on appropriate medium
  -  Oto-rhino-laryngologic (ORL) examination including ORL fibroscopy and/or optionally panendoscopy.
  2. Capacity to remain without movement during the PET/CT examination 3. ECOG performance status ≤ 2 at inclusion 4. Patient with life expectancy ≥ 24 weeks after inclusion. 5. In fertile females, at inclusion the pregnancy must be ruled out 6. Volunteer and capable to follow necessary instructions during the trial 7. Informed consent signed by the patient 8. Affiliation to a social security system
  Exclusion Criteria:
  - 1. In patients with lung cancer: lung cancer with predominance of small-cell or pure bronchioloalveolar cancer.
  2. Scheduled treatment which does not include an antiangiogenic agent 3. Patient´s physical condition not permitting participation it clinical trial according to opinion of investigator responsible of the centre 4. Pregnancy 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 Nab-Paclitaxel and Carboplatin Plus Necitumumab (LY3012211) in Participants With Stage IV Squamous NSCLC

Summary: The purpose of the study is to determine if nab-paclitaxel and carboplatin chemotherapy plus necitumumab is effective and safe in participants with stage IV squamous non-small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  Have histologically or cytologically confirmed squamous NSCLC.
  -  Have stage IV disease at the time of study entry (American Joint Committee on Cancer [AJCC] Staging Manual, 7th edition).
  -  Have measurable disease at the time of study enrollment as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
  -  Have tumor tissue available for biomarker analysis.
  -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  -  Have adequate organ functions.
  Exclusion Criteria:
  -  Are currently enrolled in another clinical trial.
  -  Have received 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.
  -  Have received previous chemotherapy for advanced NSCLC. Participants who have received adjuvant or neoadjuvant chemotherapy are eligible if the last administration of the prior regimens occurred at least 1 year prior to study entry.
  -  Have undergone major surgery or received any investigational therapy in the 4 weeks prior to study entry.
  -  Have undergone systemic radiotherapy within 4 weeks prior to study entry, or focal radiotherapy within 2 weeks prior to study entry.
  -  Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required).
  -  Have a history of arterial or venous embolism within 6 months prior to study entry.
  -  Have clinical evidence of concomitant infectious conditions.
  -  Have a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or any other contraindication to one of the administered treatments.
  -  Are pregnant or breastfeeding.
  -  Have a known history of drug abuse.
  -  Have a concurrent active malignancy. Participants with a history of malignancy are eligible provided the participant has been disease-free for ≥3 years, with the following exception: Participants with adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancer that in the judgment of the investigator and Lilly clinical research physician/designee may not affect the interpretation of results (for example, prostate, bladder) are eligible.
  -  Have discontinued investigational product or non approved use of a drug or device from a clinical trial within 30 days before the first day of study treatment.

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

Clinical trial: Study of S-588410 After Adjuvant Chemotherapy for Completely Resected Non-small- Cell Lung Cancer

Summary: In this clinical study, the investigators evaluate the efficacy and safety of S-588410 in patients who underwent an adjuvant chemotherapy after the complete resection of non-small-cell lung cancer.

Detailed description: In this phase II trial, the investigators evaluate the efficacy and safety of S-588410 containing oncoantigens-derived HLA-A*2402-restricted epitope peptides in patients with HLA-A*2402 who underwent an adjuvant chemotherapy after the complete resection of non-small-cell lung cancer.

Eligibility: Inclusion Criteria:
  1. Patients who received platinum-based adjuvant chemotherapy after the complete resection of lung cancer.
  2. Pathologically determined non-small-cell lung cancer excepting the large cell neuroendocrine carcinoma and mixed type.
  3. Patients with HLA-A*24:02.
  4. Neither recurrence nor metastasis of non-small-cell lung cancer demonstrated by imaging tests within 6 weeks prior to the registration.
  5. Possible to receive S-588410 within 12 weeks after the last adjuvant chemotherapy.
  6. ECOG performance status 0 or 1 within 2 weeks prior to the registration.
  7. Age over 20 years at time of consent acquisition.
  8. The written informed consent provided by the patient.
  Exclusion Criteria:
  1. Other malignant diseases requiring treatment, excepting the cured cancer in-situ.
  2. Concurrent treatment with anticancer drug, steroids, immunosuppressive agent, radiotherapy, immunotherapy, hyperthermia, or surgery.
  3. Active and uncontrolled infectious disease.
  4. Severe hepatic dysfunction, kidney dysfunction, cardiac disease, pulmonary disease, hematological disorder, or metabolic disease.
  5. Coronary artery stenting within 6 months prior to registration.
  6. Autoimmune disease.
  7. HIV infection.
  8. Registration within 4 weeks after the last adjuvant chemotherapy.
  9. Laboratory values defined in the protocol within 2 weeks prior to registration.
  10. Residual uncontrolled adverse events by adjuvant chemotherapy.
  11. Eosinophilia within 28 days prior to registration. Past or active eosinophilic pneumonia or interstitial pneumonitis.
  12. Past history of severe allergic reaction against drug, vaccine and biological agents.
  13. Female patient in nursing or pregnancy.
  14. Refusal of pregnancy conception.
  15. Treated with the same peptide vaccines as S-588410.
  16. Treated with another investigational drug within 28 days prior to registration or the period of 5 times of the drug half-life.
  17. Decision of non-enrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.

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

Clinical trial: Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer

Summary: A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.


Eligibility: Inclusion Criteria:
  -  Stage IIIB or IV NSCLC (any histology) at the time of study entry
  -  Histologically or cytologically confirmed diagnosis of NSCLC that is:
  1. EGFR wt as per patient standard of care by a validated test
  2. AND ALK-negative rearrangement as part of the patient standard of care by a validated test
  3. AND (by central assessment) either:
  -  Cohort 1: Pre-treated patients with cMET GCN ≥ 6 or
  -  Cohort 2: Pre-treated patients with cMET GCN ≥4 and < 6, or
  -  Cohort 3: Pre-treated patients with cMET GCN < 4, or
  -  Cohort 4: Pre-treated patients with cMET mutations regardless of cMET GCN, or
  -  Cohort 5: Treatment-naïve patients with cMET dysregulation
  -  To be eligible for Cohorts 1-4, patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
  -  To be eligible for Cohort 5, patients must not have received any systemic therapy for advanced/metastatic disease
  -  At least one measurable lesion as defined by RECIST 1.1
  -  Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
  -  Patients must have adequate organ function
  -  ECOG performance status (PS) of 0 or 1 Details and other protocol-defined inclusion criteria may apply
  Exclusion Criteria:
  -  Prior treatment with crizotinib, or any other cMET or HGF inhibitor
  -  Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations
  -  Patients with characterized ALK-positive rearrangement
  -  Clinically significant, uncontrolled heart diseases.
  -  Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study:
  -  Strong and moderate inhibitors of CYP3A4
  -  Strong inducers of CYP3A4
  -  Impairment of GI function or GI disease that may significantly alter the absorption of INC280
  -  Patients receiving treatment with any enzyme-inducing anticonvulsant
  -  Applicable to Cohorts 1-4 only: Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose
  -  Pregnant or nursing women
  -  Women of child-bearing potential, unless they are using highly effective methods of contraception
  -  Sexually active males unless they use a condom during intercourse
  Other protocol-defined exclusion criteria may apply

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

Clinical trial: A Study of LY3023414 and Necitumumab in Squamous Lung Cancer

Summary: The main purpose of this study is to evaluate the safety and activity of the study drug known as LY3023414 in combination with necitumumab in participants with metastatic squamous non-small cell lung cancer (NSCLC).


Eligibility: Inclusion Criteria:
  -  Histologically confirmed squamous advanced NSCLC (Stage IV).
  -  Participants must have progressed on one prior line of platinum-based chemotherapy in the advanced or metastatic setting.
  -  Measurable disease as measured by response evaluation criteria in solid tumors (RECIST) criteria v 1.1.
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  -  Able to swallow the study drugs whole.
  -  Adequate organ function.
  -  Women of childbearing potential must have a negative serum or urine pregnancy test performed ≤ 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 3 months following completion of study treatment.
  Exclusion Criteria:
  -  Participants who have received > 1 prior line of chemotherapy in the advanced or metastatic setting. (Immunotherapy will not be considered a line of chemotherapy.)
  -  Prior treatment with a PI3K/mTOR inhibitor, epidermal growth factor receptor (EGFR) inhibitor, and/or necitumumab.
  -  History of brain metastases unless irradiated ≥ 2 weeks prior to first study treatment and stable without requirement of corticosteroids.
  -  Have serious pre-existing medical conditions.
  -  Have insulin-dependent diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics.
  -  Women who are pregnant or breast-feeding.
  -  Clinically significant electrolyte imbalance ≥ Grade 2.
  -  Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin and oral Xa inhibitors are allowed.
  -  Have initiated treatment with bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents (e.g. denosumab) ≤ 28 days prior to Day 1 of Cycle 1.
  -  Concurrent serious infection requiring parenteral antibiotic therapy.
  -  Have a second primary malignancy that in the judgment of the investigator and Medical Monitor may affect the interpretation of results.
  -  Have an active, known fungal, bacterial, and/or known viral infection.
  -  History of arterial or venous embolism within 3 months prior to study enrollment. If the embolism occurred >3 and <6 months, the participant is eligible provided appropriate treatment according to institutional standard of care is ensured.

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

Clinical trial: A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification

Summary: The purpose of this study is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.


Eligibility: Inclusion Criteria:
  -  Locally advanced or metastatic NSCLC
  -  EGFR mutation (L858R and /or ex19del)
  -  cMET amplification by FISH (GCN ≥ 6),
  -  Acquired resistance to EGFR TKI (1st or 2nd génération)
  -  ECOG performance status (PS) ≤ 1.
  Exclusion Criteria:
  -  Prior treatment with 3rd generation TKI
  -  PhaseII : Prior treatment with any of the following agents:
  -  Crizotinib, or any other cMET inhibitor or HGF-targeting inhibitor.
  -  Concomitant EGFR TKI and platinum based chemotherapy as first line regimen.
  -  Platinum-based chemotherapy as first line treatment

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

Clinical trial: LIquid BIopsies in Lung Cancer (LIBIL)

Summary: The goal of this project is to create a biological collection of blood samples from patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) with clinical annotations.


Eligibility: COHORT 1
  Inclusion Criteria:
  -  Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) regardless of the mutation status
  -  Inclusion at the time of diagnostic
  -  Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
  -  Age ≥ 18 years
  Exclusion Criteria:
  - Patients treated before their liquid biopsy
  COHORT 2 Inclusion criteria
  -  Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) with one of the following molecular anomalies: Epidermal Growth Factor Receptor (EGFR), B-Raf proto oncogene (BRAF) or Human Epidermal Growth Factor Receptor-2 (HER2) mutations, Anaplatsic Lymphoma Kinase (ALK) or ROS porto-oncogene 1 (ROS1) translocation, Mesenchymal-epithelial transition factor (MET) amplification, RET rearrangement.
  -  Inclusion at the time of diagnostic during follow-up or at relapse
  -  Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
  -  Age ≥ 18 years
  Exclusion criteria
  - Patients treated before their liquid biopsy

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

Clinical trial: Ultra-Violet Fluorescence Bronchial Cancer Location

Summary: Diagnose lung cancer at an early stage is crucial for effective treatment. At these early stages, cancer is usually invisible in ambient white light when the endoscopic analysis of the bronchial mucosa. This lining is self-fluorescent at its illumination by blue light. These widely distributed autofluorescence methods detect early mucosal abnormalities. They are very sensitive but not specific to recognize the lung cancer. Thanks to European funding (EURIMUS), a new tool with fluorescent UV light has been developed.
  The purpose of this preliminary study is to verify the suitability for specific detection of cancerous tissue in Pneumology of this fluorescence method versus histological analysis of the tissue.


Eligibility: Inclusion Criteria:
  -  Patient affiliated or entitled to a social security scheme
  -  Major Patient
  -  Patient who signed the informed consent document
  -  Patient with a known primary cancer in bronchial level
  Exclusion Criteria:
  -  Pregnant woman
  -  Patient with a benign tumor histology
  -  Patient with an unknown tumor histology.

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

Clinical trial: Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection

Summary: This study is a prospective non-randomized controlled study. The purpose of this study is to evaluate the validity and safety of sorafenib and transcatheter arterial chemoembolization (TACE) for microvascular invasion (MVI) in hepatocellular carcinoma (HCC) patients after radical surgery.

Detailed description: HCC is the sixth most common malignancy worldwide.Selected patients with HCC are candidates for potentially curative therapy, such as hepatic resection and liver transplantation. Nevertheless,tumor recurrence is 70 % at 5 years after resection and 15-30 % after liver transplantation,leading to tumor-related death.MVI is currently one of the most critical factors predictive of HCC recurrence.There are no approved effective interventional measures to improve the outcome of this patients with MVI.The purpose of this study is to explore the validity and safety of sorafenib and TACE for MVI in HCC patients after radical resection.The candidates will be assigned to sorafenib group (about 30 cases),TACE group (about 30 patients) and control group (about 30 cases)，according to the willingness of the subject.All patients will be followed up for 3 years and Recurrence-free survival and overall survival will be recorded.

Eligibility: Inclusion Criteria:
  -  18-75 years of age;
  -  The liver tumor has been radically resected;
  -  Postoperative pathology proved to be hepatocellular carcinoma with negative margin and microvascular invasion;
  -  Imaging evaluations(CT/MRI) were performed at 1 month after the resection and no area of enhancement was seen;
  -  Child-Pugh A;
  -  Eastern Cooperative Oncology Group(ECOG) body condition score (PS) 0-1;
  -  Then patients understand and voluntarily signed a written informed consent;
  Exclusion Criteria:
  -  Recurrent HCC;
  -  pathology-proved multifocal HCC or HCC with satellite nodules;
  -  Tumor thrombus in portal vein or inferior vena cava trunk;
  -  Patients with extrahepatic metastasis found by radiologic or pathologic examination;
  -  severe dysfunction of the heart, kidney, or other organs.The patients cannot tolerate TACE or sorafenib after general assessment of the situation;
  -  Enrolled in other clinical study at the same time;
  -  Previously treated with other antitumor treatments except the resection;
  -  The researchers believe that the patient does not fit this study;
  -  Pregnant or lactating women.

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

Clinical trial: Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET

Summary: MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification [increase number of gene copies]). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments.

Detailed description: If testing has not already been performed, the study will provide for the testing.

Eligibility: Inclusion Criteria:
  -  Diagnosis of non-small cell lung cancer
  -  Metastatic or locally advanced disease
  -  Prior platinum chemotherapy or immunotherapy
  -  Test result showing genetic change in MET tumor gene
  -  At least one tumor that can be measured on a radiographic scan
  Exclusion Criteria:
  -  Prior treatment with inhibitor of MET or HGF
  -  Prior positive test for EGFR mutation or ALK gene rearrangement
  -  Uncontrolled tumor in the brain

Relevance to patient case: definitely relevant