araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Tarceva With or Without Apatinib in the Advanced Lung Adenocarcinoma

Summary: Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.

Detailed description: Lung adenocarcinoma is the most common NSCLC,most patient were diagnosed to advanced stage.The first-line therapy include chemotherapy of targeted therapy .Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.We designed the study to find out whether the addition of apatinib to the Tarceva would enhance the efficacy of Tarceva.

Eligibility: Inclusion Criteria:
  -  lung adenocarcinoma proved by histology;with mutant EGFR;ECOG PS 0-2;Clinical stage IIIb or IV;without other fatal disease;without hemorrhagic disease;normal liver,renal and bone marrow function,not pregnant.
  Exclusion Criteria:
  -  ECOG PS 3-5;abnormal liver,renal and bone marrow function,pregnant;with severe diseases;wild type EGFR

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

Summary: The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).


Eligibility: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Histologically or cytologically documented Squamous or non-Squamous Non-small cell lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following multimodal therapy
  -  Patients must have received pre-study nivolumab for up to 12 months and have 2 consecutive tumor assessments confirming Complete response (CR), Partial response (PR), or Stable disease (SD)
  -  Measurable disease before start of pre-study nivolumab treatment
  -  Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
  Exclusion Criteria:
  -  Carcinomatous meningitis
  -  Untreated, symptomatic Central nervous system (CNS) metastases
  -  Symptomatic interstitial lung disease
  Other protocol defined inclusion/exclusion criteria could apply

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Using US to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous CT Scan

Summary: Examine a new method based on fusion between ultrasound (US) and previous ultrasound/computerized tomography(US/CT) studies to evaluate the size of abdominal aneurysm and measure the changes over time and following invasive repair procedure.

Detailed description: Selection test for assessing aortic aneurysm is CT angio, it performed after injection of contrast material and allows a complete demonstration of the blood vessels. This test exposes the patient to ionizing radiation and the injection of iodine contrast medium. Repeated tests pose a risk of developing a malignancy in the future due to the use of ionizing radiation and risk of renal impairment and allergic reactions due to the injection of contrast material. Ultrasound is another test that enables the detection and evaluation of aortic aneurysm. Patients with a known diagnosis of aortic aneurysm detected on CT are required to continuous monitoring in light of its growth over time and the risk of rupture.
  Using Co-registration over the US device will enable to conduct a US directed aorta examination, which uses the information produced from the CT as a "roadmap" for detection and localization of the aneurysm. That can theoretically improve detection capabilities and characteristics of the aneurysm and outcomes of the invasive treatment.

Eligibility: Inclusion Criteria:
  •Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it.
  Exclusion Criteria:
  -  Inability to perform Ultrasound
  -  Pace maker
  -  Hemodynamic instability
  -  Inability to cooperate in US examination
  -  Pregnant Women - does not undergo CT

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

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: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC

Summary: Primary objective of this study is to allow access and evaluate the safety of crizotinib for patients in Japan with advanced NSCLC harboring a translocation or inversion involving the ROS1 oncogene.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
  -  Positive for translocation or inversion events involving the ROS1 gene as determined by protocol defined test.
  -  ECOG performance status 0 to 2.
  -  Adequate organ function
  -  Patients with brain metastases are eligible if neurologically stable for at least 2 weeks and have no ongoing requirement for corticosteroids.
  -  Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use 2 highly effective methods of contraception throughout the study and for at least 90 days after the last dose of crizotinib.
  Exclusion Criteria:
  -  Currently receiving crizotinib or any investigational products.
  -  Prior therapy specifically directed against ROS1 fusion genes including crizotinib.
  -  Carcinomatous meningitis or leptomeningeal disease.
  -  Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function.
  -  Ongoing uncontrolled congestive heart failure (CHF) and any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack.
  -  Ongoing cardiac dysrhythmias of CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QTc more than 480 msec.
  -  History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.
  -  Pregnant female patients; breastfeeding female patients.
  -  Use of drugs or foods including known potent CYP3A4 inhibitors, known potent CYP3A4 inducers and CYP3A4 substrates with narrow therapeutic indices

Relevance to patient case: possibly relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: A Study of Napabucasin (BBI-608) Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer

Summary: This is an international, multi-center, prospective, randomized, open-label Phase 3 clinical trial of the cancer stemness inhibitor napabucasin administered with weekly paclitaxel versus weekly paclitaxel alone in patients with advanced non-squamous non-small cell lung cancer who have disease progression following systemic treatment with a platinum-based combination regimen in the metastatic setting, who have received treatment with an immune checkpoint inhibitor if a candidate, additional approved therapies, and for whom weekly paclitaxel is an acceptable treatment option.


Eligibility: Key Inclusion Criteria:
  -  Must have histologically or cytologically confirmed non-squamous NSCLC.
  -  Must have progressed following treatment with platinum-based combination chemotherapy for metastatic disease, and patients with an EGFR or ALK/ROS1 genetic aberration must have received appropriately targeted treatment.
  -  Must have received either nivolumab or pembrolizumab or a different IND-approved anti-PD1 or anti-PD-L1 therapy, unless medically contraindicated
  -  Weekly paclitaxel must be an acceptable treatment option
  -  Must submit tumor tissue for correlative analyses
  -  Women of child-bearing potential and partners of women of child-bearing potential must take measures to avoid pregnancy while receiving and for a period of time following protocol therapy
  -  Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, adequate organ function, and a life expectancy of ≥ 3 months
  Key Exclusion Criteria:
  -  Has squamous NSCLC
  -  Has received prior systemic treatment with a taxane for advanced/metastatic disease
  -  Has received systemic anti-cancer therapy within the 14 days prior to randomization
  -  Has received radiotherapy within the 28 days prior to randomization, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control
  -  Has brain metastases with evolving neurologic symptoms or a steroid requirement.
  -  Has had major surgery requiring general anesthesia and/or mechanical ventilation within the 28 days prior to randomization
  -  Has a corrected QT interval (QTc) > 470 ms or has an electrocardiogram (ECG) with a new abnormal finding that is clinically significant
  -  Has peripheral neuropathy ≥ Grade 2 (NCI-CTCAE)
  -  Refuses to complete quality of life questionnaires either alone or with assistance from study staff despite adequate fluency
  -  Has an intercurrent (non-malignant) chronic medical or psychiatric illness or condition(s) not optimally controlled and carrying a moderate to high risk of interfering with protocol therapy administration or compliance with required procedures, in the judgment of the investigator

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Molecular Analysis of 150 Lung Adenocarcinoma

Summary: LUNG-EST is a retrospective study including 152 patients who benefit from lung surgery during the years 2012 to 2013 at Hospices civils de Lyon and with a diagnosis of lung adenocarcinomas. For all patients, clinical data and histopathological data are available. The objective of this study is to characterize these lung adenocarcinomas by the LungCarta Panel using the mass spectrometry array Sequenom. This panel could identify 214 DNA mutations and/or frameshift insert/deletion among 26 oncogenes. Once included in the study, the adenocarcinomas are also included in a Tissue MicroArray (TMA) in order to perform immunohistochemical analysis. Immunohistochemical staining with innovative antibodies are correlated with clinical, histopathological and molecular data.
  Our hypothesis is that this TMA could constitute a good tool to screen interesting protein's expression.


Eligibility: Inclusion Criteria:
  -  Adults
  -  lung adenocarcinoma
  -  Surgical specimen
  Exclusion Criteria:
  -  not adenocarcinoma subtype of lung cancer
  -  Tumour biopsy
  -  insufficient material for DNA extraction

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

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: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC

Summary: The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA samples in EGFR-wildtype NSCLC


Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IIIB/IV NSCLC;
  -  Histologically confirmed adenocarcinoma;
  -  EGFR-wildtype NSCLC;
  -  Provision of blood (plasma) sample for ctDNA testing;
  -  Patient must be able to comply with the protocol;
  -  Provision of blood (plasma) sample for ctDNA testing;
  Exclusion Criteria:
  -  As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
  -  Histologically confirmed small cell lung cancer or other metastatic tumors;
  -  Patient with no histologic or cytological diagnosis;

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using CT or MR/US Fusing Imaging

Summary: The purpose of this study is to determine whether fusion technique of preradiofrequency ablation (RFA) or percutaneous liver biopsy cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA or liver biopsy in patients with liver tumor in comparison with ultrasonography guidance alone. And assessment of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).

Detailed description: RFA is one of commonly used local therapies for primary or secondary liver tumors. And percutaneous liver biopsy is very important technique to confirm the diagnosis of focal hepatic lesion whether benign or malignancy.
  For successful and safe procedure, safe access route and lesion visibility are essential , and the conditions are usually evaluated on pre-procedure planning ultrasonography (USG). However, these procedure is sometimes aborted due to limited sonic window of various cause and challenging identification of small isoechoic tumors or hepatocellular carcinomas among dysplastic nodules . Therefore, precise targeting and assuring safe route would be of clinical importance. In this preliminary study, investigators attempted to determine US and CT/MR fusion technique would be able to improve RFA or liver biopsy feasibility in patients with liver tumors in comparison with conventional US alone technique.
  In addition, to assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).

Eligibility: Inclusion Criteria:
  -  all conditions should be satisfied for inclusion.
  -  referred to Radiology in our institution for liver tumor RFA or percutaneous liver biopsy
  -  available pre-procedure liver CT or liver MR imaging within 6 weeks
  Exclusion Criteria:
  -  any contraindication of liver RFA or percutaneous liver biopsy • any patients who received treatment between pre-RFA imaging and planned RFA.

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)

Summary: In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.

Detailed description: This study is designed to be multi-center, open-label, single-arm, prospective, phase II trial of patient with stage IV lung adenocarcinoma with HER2 mutation who have not received prior EGFR-TKI. Approximately 47 patients will be enrolled into the trial, and expected study duration is 36 months from IRB and Korea: MFDS approval date.
  The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria in protocol. A cycle of study treatment is defined as 28 days.

Eligibility: Inclusion Criteria:
  1. lung adenocarcinoma, stage IV
  2. Patients with HER2 mutation by sequencing
  - Confirmed triple-negative patients with remnant tumor DNA
  3. Patients who have histories of previous exposure to at least one more systemic chemotherapies (not EGFR-TKI)
  4. ECOG performance status 0~2
  5. Patient with at least one measurable lesions according to RECIST
  6. Patients who have proper organ functions as follows
  -  Neutrophil count: > 1,500/uL
  -  Platelet count: > 100,000/uL
  -  Hb: > 9.0g/dL
  -  AST/ALT : < 2.0 x upper normal limit
  -  Bilirubin: < 1.25 x upper normal limit
  -  Serum creatinine : < upper normal limit
  Exclusion Criteria:
  1. Expected lie expectancy < 3 months
  2. CNS metastasis or spinal cord compression which were not treated with operation and/or radiation therapy(but, Patient with medically stable condition after operation and/or radiation therapy, or without symptomatic metastasis of brain in accordance with the investigator's judgment could participate in the study)
  3. Patients who have severe or unstable systemic disease in accordance with the investigator's judgment(ex, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  4. Patients who have histories of previous exposure to EGFR-TKI

Relevance to patient case: not relevant