araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Intestinal Microflora in Lung Cancer After Chemotherapy

Summary: Probiotics modulate the gut microflora and immune status in lung cancer who need chemotherapy.

Detailed description: Chemotherapy destroys the intestinal mucosal barrier, affects intestinal flora, causing bacterial translocation, infection and other complications. Probiotics may restore the intestinal immunity, mucosal barrier and nutrient absorption.

Eligibility: Inclusion Criteria:
  -  Patients scheduled for chemotherapy of lung cancer
  Exclusion Criteria:
  -  Antibiotic, probiotic or prebiotic usage within 1month
  -  Other malignancy
  -  History of abdominal surgery
  -  Pregnant or breast-feeding (for females)
  -  Impaired liver or renal function
  -  Diabetes, thyroid disorder, coagulopathy or bleeding disorders, mental disorder

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

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: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

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: definitely relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Afatinib Monotherapy in Patients With ERBB (Epidermal Growth Factor Family Receptors)-Deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy

Summary: Primary objective is to investigate the efficacy in terms of 6 month progression free survival (PFS6) and objective response rate (ORR) of afatinib, in patients with advanced/metastatic urothelial tract carcinoma who have progressed despite prior platinum based chemotherapy.
  Other measures of efficacy include progression free survival (PFS), overall survival (OS), disease control rate (DCR), duration of objective response (DOR), and tumour shrinkage.


Eligibility: Inclusion criteria:
  -  Recurrent or metastatic urothelial cancer
  -  Patients must have failed prior platinum based treatment (adjuvant or 1st line)
  -  Archival tissue sample available for biomarker testing at pre-screening and tissue banking.
  -  Patients should complete a pre-screening biomarker analysis and should fulfill the following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should show EGFR (Epidermal Growth Factor Receptor) amplification.
  -  Further inclusion criteria apply
  Exclusion criteria:
  -  Prior use of EGFR, ERBB2 or ERBB3 targeted treatment
  -  Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
  -  Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis
  -  Further exclusion criteria apply

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: EBUS Score Validation for Malignancy

Summary: Surgical removal of a tumour in the lung offers the best chance for survival in early stage lung cancers. One main criteria of surgical eligibility is the absence of cancer spread to the lymph nodes; rendering the staging process extremely important. The evaluation of these lymph nodes is thought to be best completed using Endobronchial Ultrasound (EBUS), a procedure in which several lymph nodes are sampled and send to pathology to determine whether or not it is malignant. More recently, studies have observed that there are clear differences in the characteristics of cancerous and benign (non-cancerous) lymph nodes, and so there has been great interest in creating a list of criteria that can determine whether a node is malignant. This study aims to prospectively validate a previously proposed score based on observed characteristics of lymph nodes during an EBUS procedure relating to pathology-confirmed results. To test this, the results of the lymph node samples and the observed score will be compared for agreement. If the investigators find that the scoring system can accurately predict which lymph nodes are cancerous, it would provide the evidence to establish the score as a standard procedure during cancer staging.


Eligibility: Inclusion Criteria:
  -  Must be diagnosed with confirmed or suspected lung cancer and be undergoing EBUS diagnosis/staging
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

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: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

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: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery

Summary: This is a pharmacodynamic study to evaluate the effect of gefitinib as induction therapy for patients who have resectable, Epidermal growth factor receptor (EGFR) sensitizing mutation lung cancer.

Detailed description: Selected patients will receive 4 weeks of gefitinib before surgery. A Positron Emission Tomography - Computed Tomography (PET- CT) will be performed before and after gefitinib to assess the response. Circulating tumour cells (CTCs) and plasma Deoxyribonucleic acid (DNA) will be acquired at baseline, 2 weeks and 4 weeks after gefitinib treatment. Resected tumor will be sectored in details to study the spatial heterogeneity.

Eligibility: Inclusion Criteria:
  -  EGFR mutation positive Non-Small Cell lung cancer (NSCLC) (regardless of smoking status), or control group may encompass other molecular subtypes of lung cancer e.g. anaplastic lymphoma kinase (ALK) and Kirsten rat sarcoma viral oncogene homolog (KRAS).
  -  All early stage patients with NSCLC who are deemed surgically resectable.
  -  All patients must have histologically proven NSCLC, with known EGFR mutation
  -  Patients should be fit for either lobectomy/ pneumonectomy with or without lymph node sampling.
  -  Primary tumour should be at least 2 cm in size (Tumor stage 1b).
  -  Willing to provide informed consent.
  Exclusion Criteria:
  -  Known severe hypersensitivity to gefitinib or any of the excipients of this product
  -  Any serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
  -  Interstitial lung disease (ILD) or pulmonary fibrosis; impaired pulmonary function
  -  Patients with prior exposure to agents directed at the Human epidermal receptor (HER) axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
  -  Patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer therapy (e.g. monoclonal antibody therapy) for lung cancer.
  -  Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within six months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  -  Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.
  -  Patient who has serious active infection.
  -  Patients who harbouring exon 20 T(Threonine)790M (Methionine) mutation.
  -  Pregnancy or breast feeding.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

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: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

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: definitely relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA

Summary: Targeted next generation sequencing (NGS) provides a promising method for diagnostic purposes by enabling the simultaneous detection of multiple gene mutations. This study is to evaluate the feasibility and application value by using NGS into identifying genomic mutations in multiple or multifocal primary lung cancers in cell-tumor DNA (ctDNA) from surgical patients

Detailed description: Tumor samples originating from clinically considered multiple or multifocal primary lung cancer patients were available for mutational analysis. DNA and RNA were extracted from fresh tumor tissue or formalin-fixed, paraffin-embedded (FFPE) tissue. A series of cancer-related genomic alterations including single nucleotide variations (SNVs), short insertions and deletions (InDels), copy number variations (CNVs) and gene rearrangements were identified by Oncomine Comprehensive Panel(OCP). High frequency mutations were also identified in blood sample by droplet digital polymerase chain reaction(ddPCR).

Eligibility: Inclusion Criteria:
  -  Patients must have given written informed consent
  -  Histopathologically confirmed NSCLC
  -  Considered multiple or multifocal primary lung cancer by clinical criteria
  Exclusion Criteria:
  -  Malignant tumor history within the past 5 years
  -  Patients who received any treatment prior to resection
  -  Insufficient tumor tissue or blood sample

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer

Summary: Increasing evidence suggests that immune responses might be a determining factor in lung cancer tumor progression.
  The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response is required for their efficacy and highlight the critical role of antitumor T cell immunity. Recent progress on the fields of tumor immunology underlines the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.
  In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators group have previously described novel promiscuous peptides (referred as UCP:Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.
  By using UCP-based immuno-assay, pre-existing UCP-specific Th1 responses have been detected in the blood of lung cancer patients (Telocap01). The frequency and magnitude of this response were inversely correlate to the disease stage. Furthermore, UCP-specific responses were significantly found in patients with low PD1+ and TIM3+ T cells.
  Then in TeloCap02 study, UCP specific Th1 immune responses will be evaluated in lung cancer before and after treatment (chemotherapy, immunotherapy).


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer)
  -  stade IIIb or metastatic
  -  Patient candidate to a first-line therapy
  -  Performance status 0, 1 or 2 on the ECOG scale
  -  Written informed consent
  Exclusion Criteria:
  -  History of adjuvant chemotherapy for lung cancer treatment
  -  Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
  -  Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
  -  Active autoimmune diseases, HIV, hepatitis C or B virus
  -  Patients with any medical or psychiatric condition or disease,
  -  Patients under guardianship, curatorship or under the protection of justice.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks

Summary: One paraffin block is routinely used for Human Epidermal Growth Factor Receptor 2 (Her2/neu) immunohistochemistry (IHC) assessment. Here, investigators investigated if picking two or multiple paraffin blocks for Her2/neu evaluation is an economical, efficient and practical method, which may reduce false-negativity of Her2/neu IHC assessment due to intratumoral heterogeneity.


Eligibility: Inclusion Criteria:
  Age between 18 to 80; Received curative surgery with primary gastric adenocarcinoma; Did not receive any preoperative treatment.
  Exclusion Criteria:

Relevance to patient case: not relevant