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

Clinical trial: Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Summary: The program will provide early access to the investigational drug gilotrif in patients with advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or gefitinib.
  The Compassionate Use Programme will also provide additional safety information on gilotrif use.


Eligibility: Inclusion Criteria:
  1. Patients with pathologically confirmed diagnosis of adenocarcinoma of the lung Stage IV with progressive disease following at least one line of platinum-based cytotoxic chemotherapy
  2. Patients progressing after clinical benefit on erlotinib or gefitinib: clinical benefit is defined as stable disease for at least 6 months, or a complete or partial response, or the presence of an activating mutation of the epidermal growth factor (EGF) receptor family.
  3. No further treatment option is available.
  4. Male and female patients age ≥18 years.
  5. Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local law.
  Exclusion Criteria:
  1. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
  2. Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would compromise patient safety.
  3. History of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3).
  4. Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≥ three times the upper limit of normal (if related to liver metastases ≥ five times the upper limit of normal).
  5. Bilirubin ≥1.5 mg/dl
  6. Serum creatinine ≥ 1.5 times of the upper normal limit or calculated/measured creatine clearance ≤ 45ml/min
  7. Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the treatment.
  8. Pregnancy or breast feeding.
  9. Pre-existing Interstitial Lung Disease (ILD).
  10. Patients suitable to be included into afatinib clinical trials

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

Clinical trial: uPAR-PET for Prognostication in Patients With Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma and Large Cell Neuroendocrine Carcinoma of the Lung

Summary: uPAR PET/CT as a prognostic marker in non-small cell lung cancer.

Detailed description: Study I: uPAR PET/CT with 68Ga-NOTA-AE105 will be evaluated as a prognostic tool in patients with non-small cell lung cancer (NSCLC) (stage IV (Ia) operable disease (Ib)) by observer-blinded readings and compared to the prognostic performance of FDG PET/CT and prognostic biomarkers as uPAR.
  Furthermore, uPAR PET/CT will be evaluated in a pilot study in patients with malignant pleural mesothelioma (MPM) (Study II) and large cell neuroendocrine carcinoma of the lung (LCNEC) (Study III) and correlated with immunohistochemical uPAR expression.

Eligibility: Inclusion Criteria:
  Study I
  -  Histologically verified NSCLC (Study I)
  -  Stage IV disease
  -  Operable disease
  -  The participants must be capable of understanding and giving full informed written consent
  Study II
  -  Histologically verified MPM (Study II)
  -  The participants must be capable of understanding and giving full informed written consent
  Study III
  -  Histologically verified LCNEC (Study III)
  -  The participants must be capable of understanding and giving full informed written consent
  Exclusion Criteria:
  Study I, II, III
  -  Pregnancy
  -  Lactation/breast feeding
  -  Treatment with neoadjuvant chemotherapy
  -  Weight above 140 kg
  -  Allergy to 68Ga-NOTA-AE105

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

Clinical trial: KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)

Summary: The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter "the study drug") in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy.


Eligibility: Inclusion Criteria:
  -  1. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy
  -  2. Provision of signed and dated written informed consent by the patient or legally acceptable representative
  Exclusion Criteria:
  -  1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
  -  2. Pregnancy and/or breast feeding
  -  3. Current participation in any interventional trial

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

Clinical trial: PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC

Summary: The objectives of this study are to assess molecular testing, treatment patterns, and associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor) mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability of a third-generation TKI (primary study cohort). Additionally, molecular testing and treatment patterns will be assessed among a secondary cohort of patients which will include patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC.


Eligibility: Inclusion Criteria - Primary Study Cohort
  -  Provision of written informed consent (patient consent should be within 6 weeks of disease progression, defined elsewhere as the Index Date)
  -  Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
  -  Patients with prior confirmed EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC - Patients who developed resistance to an EGFR-TKI due to any other phenotypic/histologic transformations (e.g., small-cell lung cancer, EMT) or other mutations (e.g., HER2, MET amplifications) at the index-date will be eligible for participation in this study as long as they have prior confirmed diagnosis of EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC
  -  Patients who have progressed on or after EGFR-TKI therapy (i.e., gefitinib, erlotinib or afatinib) within the patient selection period
  Inclusion Criteria - Secondary Study Cohort
  -  Provision of written informed consent (patient consent should be within 6 weeks of NSCLC diagnosis, defined elsewhere as the Index Date)
  -  Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
  -  Patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC during the patient selection period. The de-novo T790M mutation can be alone or in combination with other mutations (e.g., L858R and T790M).
  Exclusion Criteria - Primary and Secondary Study Cohorts
  • Enrollment in studies that prohibit any participation in this non-interventional study. These patients will be censored.

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

Clinical trial: Epidemiological and Molecular Colorectal Cancer Registry

Summary: This is a Registry that invites patients undergoing colorectal surgery for colorectal cancer. Epidemiological data is collected. The Registry includes tumor tissue and blood banks for analyzing different genetic mutations and disease-specific biomarkers.


Eligibility: Inclusion Criteria:
  -  Adult patients undergoing colorectal surgery for colorectal cancer.
  Exclusion Criteria:
  -  Unwillingness to participate.

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

Clinical trial: A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis

Summary: Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT) chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in selected NSCLC patients in some retrospective research. Our single-center prospective research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A multi-center prospective observational biomarker study will be started in 11 lung cancer center based on our single-center prospective research result. The aims of the study are to find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical assessment criteria for NSCLC-LM EGFR-TKIs treatment.


Eligibility: Inclusion Criteria:
  1. The cytological identification of malignant cells within cerebrospinal fluid (CSF).
  2. Non-small cell lung cancer patients.
  3. Tumor specimens or cytology specimens can be used for the EGFR gene mutation detection.
  4. The entails examining cerebrospinal fluid could be obtained by lumbar puncture.
  5. Expected survival time is greater than 1 month.
  Exclusion Criteria:
  Patients with radiologic evidence of LM not confirmed by positive CSF cytology.

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

Clinical trial: Acquired Resistant Mechanism of the First-generation EGFR TKIs

Summary: Patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive epithelial growth factor receptor (EGFR) mutations invariably develop acquired resistance to EGFR tyrosine kinase inhibitors (TKIs). Identification of actionable genetic mutations can be helpful for guiding the subsequent treatment. This study aimed to analyze the genetic profile of NSCLC harboring acquired resistance to the first-generation EGFR TKIs using next generation sequencing (NGS).


Eligibility: Inclusion Criteria:
  -  Histologically proven stage IIIB or IV non-small cell lung cancer
  -  patients harboring sensitive EGFR mutations and received first-generation EGFR-TKIs who developed acquired drug resistance
  -  patients who can provide pre-treatment (EGFR TKIs) tumor tissues
  -  patients with tumor lesions to be re-biopsy after drug resistance
  -  patients must sign an informed consent indicating that they are aware of the .investigational nature of the study in keeping with the policy of the hospital.
  Exclusion Criteria:
  -  History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  -  patients with other systemic diseases

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

Clinical trial: Association of Bone and Metabolic Parameters With Overall Survival in Patients With Bone Metastases From Adenocarcinoma Lung Cancer (POUMOS)

Summary: Mortality due to non small cell lung cancers is the first cause of cancer death in men around the world. Lung adenocarcinoma regularly induces bone metastases responsible for high morbidity and impaired life quality. Overall survival of these patients is poor. Thus the investigators aimed to identify if some bone and metabolic parameters were associated with overall survival.
  Patients and Methods POUMOS is a prospective cohort of patients suffering from adenocarcinoma lung cancers with a first bone metastasis (stage IV). All patients have a bone biopsy with molecular status characterization of the tumor for EGFR, KRAS, BRAF and ALK. Bone metastasis localizations are obtained by bone scintigraphy or FDG-PET/CT. Whole body composition is obtained by DEXA scan (Hologic®). The investigators assessed also fasting blood levels of bone and metabolic biomarkers.
  Survival analyses will be performed using a proportional hazard regression model.


Eligibility: Inclusion Criteria:
  -  adults over 18 years
  -  both gender
  -  covered by the French National Insurance
  -  first bone metastases of adenocarcinoma lung cancer (synchronous or metachrone)
  Exclusion Criteria:
  - adenocarcinoma previously treated by systemic oncologic treatment (chemotherapy, targeted therapy, immunotherapy)

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

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: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

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: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Evaluation of the Resection of Adenoma and Colic Adenocarcinoma by EMR Piecemeal or EMR/ESD Hybrid Technique

Summary: For tough colic resection, evaluation of our practice for these lesions unresectable in monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy dissection) /ESD (submucosal dissection)


Eligibility: Inclusion Criteria:
  -  Age > 18 years,
  -  Patient with colorectal adenoma or intramucinous adenocarcinoma
  Exclusion Criteria:
  -  Contraindication surgery

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

Clinical trial: Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer

Summary: The purpose of this study is:
  1. To establish a set of diagnostic criteria of intraoperative frozen section of early stage lung adenocarcinoma, including clinicopathologic and molecular characteristics.
  2. To assess its clinical usefulness in guiding surgical procedure for early stage lung adenocarcinoma.

Detailed description: The detection rate of small pulmonary nodules is increasing due to the widespread use of high-resolution computed tomography (CT) screening in clinical practice. These minute pulmonary nodules are suggestive of atypical adenomatous hyperplasia (AHH), adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA), and invasive adenocarcinoma. Hence, the precision diagnosis of intraoperative frozen section is particularly imperative for its fundamental role in assess indeterminate lung lesions and guide the extent of subsequent surgical procedure.
  However, it is still difficult for the surgical pathologist to apply the various features according to the newly revised WHO classification of lung adenocarcinoma (2015) to guide surgical management due to their unascertained accuracy or heterogeneity of lung cancer or technique problem. Therefore, the establishment and assessment for a set of diagnostic criteria of intraoperative frozen section of early stage lung adenocarcinoma are our primary aim in this study.

Eligibility: Inclusion Criteria:
  1. Patients with suspected pulmonary nodules (5~20 mm) by chest CT scan;
  2. Patients received surgical operation.
  Exclusion Criteria:
  1. Patients compliance is poor and cannot accept follow-up;
  2. Patients nursing or pregnant;
  3. Patients with a history of any cancer;
  4. Patients with confirmed pathological diagnosis or received radiotherapy or chemotherapy or target therapy preoperatively.

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

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