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

Clinical trial: An Expanded Access Study of Brigatinib for Patients With ALK-positive Advanced Non-Small Cell Lung Cancer

Summary: The purpose of this study is to provide brigatinib for those patients with locally advanced and/or metastatic patients with ALK+ NSCLC on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.


Eligibility: Inclusion Criteria:
  1. Have histologically or cytologically confirmed locally advanced or metastatic NSCLC that is determined to have an ALK-rearrangement detected according to local standard procedure.
  2. Resistant to or intolerant of at least 1 prior ALK TKI.
  3. Recovered from toxicities related to prior anticancer therapy to NCI CTCAE, v4.0) grade ≤2.
  4. Are a male or female patient ≥18 years old.
  5. Have adequate organ and hematologic function, as defined by the study protocol.
  6. Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  7. Have normal QT interval on screening electrocardiogram (ECG) evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ≤450 ms in males or ≤470 ms in females.
  8. For female patients of childbearing potential, a negative pregnancy test must be documented prior to enrollment (<7 days prior to the first dose).
  9. Female and male patients who are fertile must agree to use a highly effective form of contraception as defined by the study protocol.
  10. Must provide a signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.
  Exclusion Criteria:
  1. Received an ALK TKI within 10 days prior to the first dose of brigatinib.
  2. Received cytotoxic chemotherapy, investigational agents, or radiation within 14 days, except stereotactic radiosurgery (SRS) or stereotactic body radiosurgery.
  3. Received prior brigatinib therapy.
  4. Received monoclonal antibodies within 30 days of the first dose of brigatinib.
  5. Had major surgery within 30 days of the first dose of brigatinib.
  6. Have current spinal cord compression.
  7. Have significant, uncontrolled, or active cardiovascular disease within 6 months prior to first dose, as defined by the study protocol.
  8. Have a history or the presence of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis.
  9. Have a known or suspected hypersensitivity to brigatinib or its excipients.
  10. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety.
  11. Are pregnant or breastfeeding.
  12. Are eligible for and have reasonable access to participate in another ongoing brigatinib clinical study.

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

Clinical trial: Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients

Summary: A multi-centre observational, non-interventional study is to dynamically monitor the changes of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.


Eligibility: Inclusion Criteria:
  -  Provision of informed consent
  -  Histologically confirmed stage IIIB/IV NSCLC.
  -  Activating EGFR mutations (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q)
  -  Able to comply with the required protocol and followed-up procedures, and able to receive oral medications
  Exclusion Criteria:
  -  Histologically confirmed small cell lung cancer or other metastatic tumors
  -  Patient had received prior chemotherapy or EGFR-TKIs treatment
  -  Patients who harbor Exon20 T790M mutation

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 CA-170 (Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) in Patients With Advanced Tumors and Lymphomas

Summary: CA-170 is a rationally designed and orally available, small molecule that directly targets the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints and results in activation of T cell proliferation and cytokine production. This is a multi-center, open-label, Phase 1 trial of orally administered CA-170 in adult patients with advanced solid tumors or lymphomas who have progressed or are non-responsive to available therapies and for which no standard therapy exists.


Eligibility: Inclusion Criteria:
  1. Males and females ≥ 18 years of age;
  2. Life expectancy of at least 3 months;
  3. ECOG PS ≤ 1;
  4. Acceptable bone marrow and organ function at screening;
  5. Ability to swallow and retain oral medications;
  6. Negative serum pregnancy test in women of childbearing potential;
  7. Measurable disease;
  8. Tumor for which standard therapy, including approved anti-PD-1 or anti-PD-L1 therapy, when applicable, does not exist or is no longer effective.
  Exclusion Criteria:
  1. Prior treatment anti-cancer therapy or use of any investigational agent within the past 28 days or 5 half-lives, whichever is shorter;
  2. Toxicity from prior chemotherapy that has not resolved to Grade ≤ 1;
  3. Radiotherapy within the last 21 days;
  4. Primary brain tumors or CNS metastases;
  5. Major or minor surgery < 28 and <14 days from the start of treatment, respectively;
  6. Active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications;
  7. Active infection requiring systemic therapy;
  8. Receipt of vaccines against infectious diseases within 28 days;
  9. HIV positive or an AIDS-related illness;
  10. Active/chronic HBV or HCV infection;
  11. Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;
  12. Cardiac dysrhythmias;
  13. Gastrointestinal disease that interferes with receipt of oral drugs;
  14. Concomitant malignancy;
  15. Pregnant or lactating female;

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

Clinical trial: Responses to Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation

Summary: This chart review describe the response to systemic chemotherapy of patients with non-small cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor receptor 2 (HER2) mutation. The analysis of this data will provide an initial description of the response to systemic chemotherapy in patients with NSCLC harboring an activating HER2 mutation in order to inform the design and powering of future randomized controlled clinical trials of HER2-directed therapy.


Eligibility: Inclusion Criteria:
  -  patients with advanced nonsmall-cell lung cancer
  -  known HER2 exon-20 insertion
  -  treated with chemotherapy and/or HER2-targeted drugs
  Exclusion Criteria:

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

Clinical trial: Study of the Quality of Lung Resection

Summary: In 2009, centres that carried out lung resection for cancer were required to obtain authorization following the first cancer plan. One of the criteria to obtain authorization was the volume of activity: the centre had to carry out at least 30 lung resections per year for cancer. Five years later, it would be useful to know the impact of this new organization of oncology on the quality of care. To answer this question, the PMSI database is an ideal source of an indicator of quality: in-hospital mortality. This observational cohort study will be conducted using the national PMSI database with data covering the period from 1st January 2005 to 31st December 2013. It will be limited to hospitalization for lung resection. The time will be divided into 3 periods: 2005-2007, 2008-2010 and 2011-2013; the period 2008-2010 includes the implementation of authorizations for cancer surgery.


Eligibility: Inclusion Criteria:
  Any patients who underwent lung resection for bronchial cancer will be included in this study. The PMSI (Programme de Médicalisation des Systèmes d'Information) database will be searched for all patients with:
  -  A principal diagnosis of ICD10 (international classification of diseases) codes for bronchial cancer
  -  And CCAM (Classification Commune des Actes médicaux ) procedure codes for lung resection (segmentectomy, lobectomy, pneumonectomy).
  Exclusion Criteria:

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

Clinical trial: Cisplatin, Carboplatin, Oxaliplatin, Docetaxel and Gemcitabine Plus Surgery for Recurrent Non-Small Cell Lung Cancer

Summary: The purpose of this study is to determine if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer patients.

Detailed description: Lung carcinoma is a malignant disease characterized by uncontrolled alveolar type II epithelial cell growth in lung tissues. Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths, making it the most common cause of cancer-related death in men and second most common in women after breast cancer. The most common age at diagnosis is 70 years, and less than 20% of people diagnosed with lung cancer can survive five years post diagnosis. The two main types of lung carcinomas are small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC). NSCLC represents the most common type of lung cancers, and approximately 85% of lung cancers are NSCLC. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of NSCLC, the latter associated with high mortality in overall cancer populations with limited treatment options.
  In this study, the investigators performed a Phase I, open label, agent-combination exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with recurrent NSCLC who have undergone prior surgery for the primary disease. Up to four cohorts have been enrolled to determine the effectiveness and safety of single or combinational therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.

Eligibility: Inclusion Criteria:
  -  Age ≤ 75 years with histologically proven NSCLC
  -  No severe major organ dysfunction
  -  WHO performance status of 0 or 1
  -  No prior cancer chemotherapy
  -  A Clinical Stage ≥ IA (T1a, N0, M0) of lung disease but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan.
  Exclusion Criteria:
  -  Age ≥ 76
  -  Severe major organ dysfunction
  -  WHO performance status of >1
  -  Prior cancer chemotherapy
  -  Stage IV

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

Clinical trial: Yoga in Improving Quality of Life in Patients With Non-small Cell Lung Cancer Undergoing Treatment

Summary: The purpose of this research study is to evaluate the effects of yoga (including breathing exercises) on the quality of life in patients, diagnosed and undergoing standard treatments for non-small cell lung cancer.

Detailed description: This clinical trial studies yoga in improving quality of life in patients with non-small cell lung cancer undergoing treatment. Yoga may help improve quality of life and pulmonary functional capacity in patients with non-small cell lung cancer.

Eligibility: Inclusion Criteria:
  -  Patients with any type of non-small cell lung cancer who are undergoing medical treatment, including surgery, radiation and / or chemotherapy.
  Exclusion Criteria:
  -  Metastasis to the brain, problems during surgery leading to myocardial infarction or hemorrhage, cerebral infarction or hemorrhage, respiratory failure, non-healing surgical wound.

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

Clinical trial: First-in-human Phase I Study of a Selective c-Met Inhibitor PLB1001

Summary: This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1001.

Detailed description: This is a Phase I, open-label, multicentre study of PB1001 administered orally to patients with Met-positive (Met+) advanced NSCLC. The study includes a Dose-escalation Part (part A)and a Dose Expansion Part(part B). The aim of the part A is to estimate the MTD and to identify the dose limited toxicity(DLT) and the recommended phase II dose (RP2D) for PLB1001 single agent as well as to determine the PK/PD profile .Once response has been observed in certain dose level ,then followed by the expansion part to further assess the clinical efficacy and safety of PLB1001 single agent. Aprox. 40 patients will be enrolled in PART A, while 20-30 patients for expansion cohort .
  PLB1001 is a potent selective c-Met inhibitor. PLB1001 acts on cancer by blocking abnormal cmet-mediated signalling, leading to profound tumour growth inhibition in xenografts of non-small cell lung cancer (NSCLC) tumours. Preliminary data from a c-Met inhibitor INC 280 has provided possibility on the safety and clinical activity of PLB1001 monotherapy in this patient population.

Eligibility: Inclusion Criteria:
  -  Signed Informed Consent Form
  -  Age≥18 years
  -  Histologically or cytologically confirmed advanced non-small cell lung cancer
  -  Must have evidence of c-Met positivity from the results of molecular pre-screening evaluations
  -  At least one measurable lesion as per RECIST v1.1
  -  Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1
  -  ECOG Performance Status of 0-2
  Exclusion Criteria:
  -  Previous or current treatment with a c-Met inhibitor or HGF-targeting therapy
  -  Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits.
  -  Clinically significant, uncontrolled heart diseases. Unstable angina History of documented congestive heart failure (New York Heart Association functional classification > II) Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 145 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 85 mm Hg Arrhythmias
  -  Active peptic ulcer disease or gastritis
  -  Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
  -  Major surgery within 4 weeks prior to starting PLB1001
  -  Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1001. If previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 6 weeks before first dose of PLB1001.
  -  Pregnant or nursing women
  -  Involved in other clinical trials < 30 days prior to Day 1

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

Clinical trial: A Phase II Study of HMPL-504 in Lung Sarcomatoid Carcinoma

Summary: This is a Phase II, open-label, multicenter study of Savolitinib administered orally once per day(QD) to locally advanced/metastatic PSC patients with MET Exon 14 mutation. The targeted population is the patients with MET Exon 14 mutation who have failed prior systemic therapy (ies), or are unwilling or unable to receive chemotherapy. Pathological diagnosis will be confirmed retrospectively by the central pathological laboratory.

Detailed description: Savolitinib will be administrated 600mg once per day (QD). The treatment will be discontinued for the patients who experience disease progression, death or experience unacceptable toxicity, whichever occurs first. A cycle of study treatment will be defined as 21 days of continuous dosing.

Eligibility: Inclusion Criteria:
  -  1.Fully understood the study and voluntarily signed Informed Consent Form
  -  2.Age > 18 years
  -  3.Histologically or cytologically documented locally advanced or Metastatic pulmonary sarcomatoid carcinoma (PSC) patients with MET Exon 14 mutation who have failed piror systemic therapy(ies), or are unwilling or unable to receive chemotherapy
  -  4.Patient should have measurable disease per RECIST1.1
  -  5.ECOG performance status of 0, or 1
  -  6.Expected survival > 12 weeks
  Exclusion Criteria:
  -  1.Co-existing malignancy or malignancies diagnosed within the last 3 years other than lung cancer with the exception of adequately treated skin basal cell carcinoma or cervical cancer in situ.
  -  2.Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 3weeks prior to initiation of study treatment, or received TKI (for ex. EGFR-TKI) treatment within 2 week prior to initiation of study treatment
  -  3.Palliative radiation to bone metastases within 2 weeks prior to the initiation of study treatment
  -  4.Herbal therapy within 1 week prior to the initiation of study treatment

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

Clinical trial: Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC

Summary: The main objective of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics of BPI-9016M in patients with c-Met-dysregulated advanced NSCLC.Biomarkers related to the efficacy of BPI-9016M will be investigated.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed, locally advanced or metastatic NSCLC patients, who is not suitable for surgery or radiotherapy
  -  Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST1.1)
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  -  Life expectancy ≥12 weeks
  -  Must have evidence of positive c-Met protein expression by IHC from either local data or the results of molecular pre-screening evaluations.
  -  Adequate bone marrow, hepatic, and renal function
  -  Patients of child bearing potential must agree to take contraception during the study and for 90 days after the last day of treatment
  -  Signed Informed Consent Form
  Exclusion Criteria:
  -  Prior or current treatment with a c-MET inhibitor or HGF-targeting therapy
  -  Confirmed ALK or ROS1 rearrangement
  -  Prior treatment with targeting agents (Including EGFR tyrosine kinase inhibitors,VEGFR TKIs etc.) within 14 days or 5 half-life
  -  Prior treatment with anticancer agents (Including cytotoxic chemotherapy,radiotherapy, immunotherapy etc.) within 4 weeks
  -  Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for maintenance
  -  History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease, radiological documentation of idiopathic pulmonary fibrosis at baseline; uncontrolled pleural effusion/pericardial effusion
  -  Any evidence of severe or uncontrolled systemic diseases, including CTCAE 2 or higher active infection, unstable angina pectoris, congestive cardiac failure and severe liver/renal or metabolic disease
  -  Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
  -  History of organ transplant; had surgery or severe injury within 4 weeks
  -  Uncontrolled hypertension（Systolic blood pressure≥160mmHg and/or diastolic blood pressure≥100mmHg ）
  -  Patients unable to swallow orally administered medication, prior surgical procedures affecting absorption.
  -  Pregnant (positive pregnancy test) or lactating women

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

Clinical trial: Bronchoscopy With Bronchoalveolar Lavage in Identifying Biomarkers of Response to Immune Checkpoint Inhibitors in Patients With Non-small Cell or Small Cell Lung Cancer

Summary: This pilot clinical trial studies how well bronchoscopy with bronchoalveolar lavage works in identifying biomarkers of response to immune checkpoint inhibitors in patients with non-small cell or small cell lung cancer. Bronchoscopy uses a thin, tube-like instrument inserted through the nose or mouth to view the inside of the trachea, air passages, and lungs. Bronchoalveolar lavage washes out the bronchi and alveoli by flushing with a fluid. Bronchoscopy with bronchoalveolar lavage may make it easier to help determine biomarkers that are more present in some cancers than others that will help determine which individuals have a greater or lesser chance of benefiting from immunotherapy.

Detailed description: PRIMARY OBJECTIVES:
  I. To discover predictive immune biomarkers of response to immune checkpoint inhibitor therapy in individuals with primary lung cancer.
  SECONDARY OBJECTIVES:
  I. To determine biomarkers that may be predictive of treatment related adverse events, specifically pneumonitis.
  II. To further elucidate lung immunologic microenvironment by performing single cell analysis in addition to mass cytometry (Cytof) on cells of bronchoalveolar lavage.
  OUTLINE:
  Patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes.
  After completion of study, patients are followed up at 3, 6, 12, and 24 months.

Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
  -  Candidate to undergo immune checkpoint inhibitor (ICI) therapy for SCLC or NSCLC (ICI as any line of chemotherapy is acceptable) as deemed by individual's treating oncologist
  -  Enrollment into this study may occur in tandem with other clinical therapeutics trials occurring at Vanderbilt University Medical Center (VUMC) as long as this trial does not violate protocol or inclusion criteria of that study
  Exclusion Criteria:
  -  Coagulopathy with international normalized ratio (INR) > 2.0 or
  -  Coagulopathy with platelets (Plt) < 10 k
  -  Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  -  Subjects with an active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids/immunosuppressive medications
  -  Respiratory failure requiring greater than 6 Lpm supplemental oxygen (O2) by nasal cannula or mechanical ventilation within the past six weeks
  -  Inability to perform informed consent due to any medical or psychiatric condition

Relevance to patient case: not relevant