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

Clinical trial: A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Summary: This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.


Eligibility: Inclusion Criteria:
  -  Adult participants greater than or equal to 18 years of age
  -  Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
  -  Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
  -  PD-L1-positive tumor status as determined by an immunohistochemistry (IHC) assay based on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory
  -  Measurable disease, as defined by RECIST version 1.1
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  Exclusion Criteria:
  -  Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed:
  Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs) approved for treatment of NSCLC discontinued >7 days prior to Cycle 1, Day 1
  -  Central nervous system (CNS) disease, including treated brain metastases
  -  Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome
  -  History of autoimmune disease
  -  History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted
  -  Active hepatitis B or hepatitis C
  -  Human Immunodeficiency virus (HIV) positive
  -  Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents

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

Clinical trial: Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer

Summary: The purpose of this study is to study the effect of hormone therapies (androgen pathway modification) on the outcomes of patients with lung cancer. This information may be of benefit for future treatment strategies, prevention and control.
  In this study, the protein where testosterone binds, called the androgen receptor (AR), will be measured in samples from the patient's biopsy and surgical tumor samples. The investigators will look at a marker of how fast the cancer is growing (Ki67) before using finasteride from your biopsy specimen. Finasteride will be taken from the day of consent until the day of the patient's surgery. This marker will be measured again after using finasteride from the surgical specimen. The investigators will be looking for a decrease in the Ki67 from the patient's biopsy specimen to the surgical specimen as an indicator that this medication is blocking tumour growth.


Eligibility: Inclusion Criteria:
  -  male
  -  age >18
  -  biopsy-proven non-small cell lung cancer
  -  surgical intervention planned
  Exclusion Criteria:
  -  current use of 5-alpha reductase inhibitor
  -  previous diagnosis of prostate cancer
  -  previous hypersensitivity to 5-alpha reductase inhibitor

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

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: 68-year-old male with non-small cell carcinoma; genetic feature: MET

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: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Aprepitant for Chemotherapy Induced Nausea and Vomiting in Chinese Advanced Non-small Cell Lung Cancers

Summary: Aprepitant is an oral neurokinin-1(NK-1) antagonist which is widely used for the prevention of chemotherapy-induced nausea and vomiting(CINV), it is metabolized by CYP34A, however, up to now it was still unknown the CINV control rate of aprepitant in Chinese non-small cell lung cancer(NSCLC) patients, we hypothesis that CYP3A4 and NK-1 polymorphism would influence aprepitant plasma concentration, which may lead to the individual difference of CINV control rate.

Detailed description: Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN non-small cell lung cancer guide line(2014 V2),the patient should receive standard platinum based chemotherapy, are randomized divided into two groups, aprepitant group and placebo group. In aprepitant group, patients would receive aprepitant 125 mg at day1, then 80 mg at day2 and day3. In placebo group, patients would receive placebo from day1 to day3. In both group, dexamethasone and 5-HT inhibitor palonosetron were give at the same dose. During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV, other side-effects should be recorded. In aprepitant group, plasma should be taken for the analyze of plasma concentration, gene polymorphism of CYP3A4 and NK-1 should be analyzed for all the patients who received aprepitant if possible.

Eligibility: Inclusion Criteria:
  -  patients pathologic diagnosed of advanced non-small cell lung cancer
  -  according to NCCN non-small cell lung cancer guide line(2014 V2), patients are suitable for platinum based chemotherapy.
  Exclusion Criteria:
  -  patients could not receive platinum based chemotherapy judged by clinical doctors
  -  pregnancy or breast-feeding women
  -  any serious disease which could not be controled
  -  urine protein≥++, or 24h urine protein＞1g
  -  less than 18 years old or more than 75 years old

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

Clinical trial: Study of Safety and Efficacy of INC280 and Cetuximab, in Adult c-MET Positive mCRC and HNSCC Patients After Progression on Cetuximab or Panitumumab Therapy

Summary: This is an open-label, phase Ib, multicenter clinical trial to determine the MTD/RDE of the orally administered c-MET inhibitor INC280 in combination with cetuximab. This combination will be explored in c-MET positive mCRC and HNSCC patients whose disease progressed on cetuximab or panitumumab treatment. The dose escalation part will be guided by a Bayesian Logistic Regression Model with overdose control. At MTD/RDE, additional mCRC and HNSCC patients who have progressed on cetuximab or panitumumab treatment will be enrolled in two expansion groups to further assess the anti-tumor activity and the safety and tolerability of the combination of INC280 and cetuximab. Patients will receive INC280 on a continuous bid dosing regimen and cetuximab every week. A treatment cycle is defined as 28 days with no scheduled break between cycles.


Eligibility: Inclusion Criteria:
  -  Male or female aged ≥ 18 years
  -  Metastatic colorectal cancer or head and neck squamous cell carcinoma
  -  c-MET positive (defined by c-MET IHC intensity score +2 in ≥ 50% of tumor cells and MET gene copy number ≥ 5 by FISH or IHC intensity score +3 in ≥ 50% of tumor cells) and K/NRAS WT status for mCRC patients only
  -  At least one previous line of treatment for the metastatic disease and the last treatment must have included cetuximab or panitumumab. Documentation of clinical benefit and subsequent progression on cetuximab or panitumumab as the most recent line of treatment is required for patients in the expansion part
  -  Measurable disease as per RECIST v1.1
  -  ECOG performance status ≤ 2
  Exclusion Criteria:
  -  Prior treatment with c-MET/HGF inhibitors
  -  History of severe reactions to cetuximab and/or panitumumab (except for G3 rash and G3 hypomagnesaemia)
  -  History of acute or chronic pancreatitis
  -  Active bleeding within 4 weeks prior to screening visit
  -  Symptomatic brain metastases
  -  Feeding tube dependence
  -  Not adequate hematologic, renal and hepatic function
  Other protocol-defined inclusion/exclusion criteria may apply NVS Definition: List only the main study specific inclusion/exclusion criteria that patients will understand.
  Note: DO NOT cut/paste directly from the protocol.
  Do not include age and gender as part of this field. Age and gender are indicated in the 2 fields below.
  Always include statement "Other protocol-defined inclusion/exclusion criteria may apply" at the end of this section.
  Examples:
  Inclusion criteria:
  Patients within 7- 42 days of an acute myocardial infarction associated with left ventricular systolic dysfunction Qualifying Echocardiogram at Visit 1
  Exclusion criteria:
  Presence of clinically overt heart failure Percutaneous coronary intervention (PCI) less than 24 hours before randomization previous treatment with aliskiren
  Other protocol-defined inclusion/exclusion criteria may apply.

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

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

Clinical trial: Phase I Hypofractionated Stereotactic Boost (Radiotherapy) for Non-Small Cell Lung Cancer

Summary: This study will help researchers test the safety of hypofractionated dose of radiotherapy (HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung Cancer.

Detailed description: Patients are assigned to Sub-group 1 or 2 based on the primary lesion size and location. This protocol will utilize a standard 3 + 3 phase I design with three patients enrolled per cohort.
  Patients will be offered the opportunity to participate in the blood specimen component of the study.
  Patients will be followed up to 2 years post radiation therapy.
  Sub-group 1 will receive HySBst for 1 week. Weeks 2-7 will be standard chemo-radiation therapy. Patients have the option of consolidative chemotherapy at week 12.
  Sub-group 2 will receive standard chemo-radiation therapy for weeks 1-6 then receive HySBst during week 7. Patients have the option of consolidative chemotherapy at week 12.
  HySBst dose escalation for each sub-group is listed below:
  Optional: 4 Gy x 4 daily fractions Level 1: 5 Gy x 4 daily fractions Level 2: 5.5 Gy x 4 daily fractions Level 3: 6 Gy x 4 daily fractions
  DLTs will be based on events occurring during the course of HySBst.
  Chemo-Radiation Therapy is defined as:
  Standard Carboplatin & Paclitaxel Doublelet Regimen with weekly Carboplatin AUC 2/week and Paclitaxel 45 mg/ m2/ week during conventionally fractionated IMRT
  Image-guided IMRT to 60 Gy, 5 x per week for 6 weeks
  Consolidative chemotherapy is defined as Carboplatin AUC 6 and Paclitaxel 200 mg/m2 every 21 days x 2 cycles will be given after ALL radiotherapy is delivered.

Eligibility: Inclusion Criteria:
  -  Stage II - III Non Small Cell Lung Cancer
  Exclusion Criteria:
  -  Primary tumor directly invading into any mediastinal structures, such as the heart, major blood vessels, esophagus, trachea, and the proximal bronchial tree.
  -  Prior chemotherapy for NSCLC
  -  Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
  -  Severe, active co-morbidity
  -  Pregnancy or women of childbearing potential
  -  Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin
  -  Uncontrolled neuropathy ≥ grade 2.

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

Clinical trial: Phase II Image Guided Stereotactic Ablative Radiotherapy for Non-Small Cell Lung Cancer

Summary: This study will help researchers learn about the best dose of radiation to be used when treating large early stage non-small cell lung cancer (NSCLC) with a treatment called stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage NSCLC show positive response. But, for large early stage NSCLC it may be better to give different SABR doses than what is used in routine early stage NSCLC treatment. It is not understood which dose is best for treating large early stage NSCLC. Therefore, this study can help researchers learn if giving a higher dose using SABR over a period of 5-10 treatment days can increase the chance of cure for large early stage NSCLC.

Detailed description: Treatment Plan:
  7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT.
  -  Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved; but the 7.5 Gy x 10 daily fractions schedule is preferred.
  -  All doses are prescribed to the tumor periphery.
  For this protocol, patients will be followed only up to 2 years post radiation therapy.

Eligibility: Inclusion Criteria:
  -  Non-Small Cell Lung Cancer
  -  T2N0M0 or T3(PL3)N0M0 or Locally recurrent ≤ 7 cm
  -  Surgically inoperable
  -  ECOG Performance 0-2
  Exclusion Criteria:
  -  Pacemaker on the same side of the tumor
  -  Pregnant
  -  Infection that requires IV antibiotics
  -  Concomitant or adjuvant anti-neoplastic chemotherapy

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

Clinical trial: SAS in Patients With Bronchial Carcinoma

Summary: In this study it will be analyzed how often the sleep apnea syndrome can be observed in patients with newly diagnosed lung cancer with the help of ApneaLink device by ResMed.

Detailed description: Determination of the SAS- frequence in patients with bronchial carcinoma. The patients will be screened at home for 1 night with the ApneaLink device by ResMed. The apneaLink device is a standard screening tool for sleep apnea in clinical practice.

Eligibility: Inclusion Criteria:
  -  Patients with reasonable suspicion of bronchial carcinoma or histologically proven bronchial carcinoma, which has not been medicated until the study entry and
  -  Patients with sleep apnea who had recently been diagnosed with bronchial carcinoma.
  Exclusion Criteria:
  -  Pregnancy
  -  other already known malignancies or tumors
  -  Patients with non-invasive artificial respiration due to a chronic respiratory insufficiencies

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

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

Clinical trial: Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer

Summary: The purpose of this study is to compare early-stage peripheral non-small cell lung cancer lobectomy and sub-lobectomy surgery to evaluate if sub-lobectomy is as feasible and effective for the treatment of early-stage (diameter ≤2cm) peripheral non-small cell lung cancer as lobectomy.

Detailed description: Objectives:To establish a database of patients with early lung cancer surgery,and evaluate if sub-lobectomy surgery is as feasible and effective as lobectomy surgery in patients with early-stage peripheral non-small cell lung cancer,by assessing the retainability of lung function.and improvement of quality of life in those patients.
  Outline:This is a prospective, matched, controlled, open, multi-center clinical study. Select the early-stage peripheral NSCLC 630 patients (diameter≤2cm), according to age and lesion type (GGO component ratio) two matching factor of 1: 2 assigned to sub-lobectomy group and lobectomy group.Patients are followed up every 3 months for the first year and then every 6 months for the other 4 years.

Eligibility: Inclusion Criteria:
  1. clinically diagnosed with stage I peripheral non-small cell lung cancer suitable for lobectomy.
  2. T≤2cm，N0，M0.
  3. aged 60 to 80 years old.
  4. ECOG≤2.
  5. according to the Ministry of Health, "with primary lung cancer diagnostic and treatment practices" (2011 edition) completed preoperative clinical staging examination.
  6. voluntary participation, signed informed consent.
  Exclusion Criteria:
  1. pathologic stage is N1, N2, or M1a.
  2. received postoperative adjuvant therapy (chemotherapy or targeted therapy).
  3. radiotherapy or chemotherapy before surgery.
  4. small cell lung cancer
  5. benign lesions
  6. patient unwilling to cooperate with surgery or observation.

Relevance to patient case: not relevant