araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Second-line Treatment With Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression (IHC 3+) or Positive FISH

Summary: This study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH, the primary endpoint is objective response rates.

Detailed description: Epidermal growth factor receptor (EGFR) signaling is critical for cancer cell proliferation, invasion, metastasis, and resistance to apoptosis.EGFR is overexpressed in many epithelial malignancies and therefore makes an attractive therapeutic target.This study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH, the primary endpoint is objective response rates. Secondary endpoints include progress-free survival, overall survival, safety and so on.

Eligibility: Inclusion Criteria:
  -  Patients with a histologic or cytologic diagnosis of carcinoma of the gastroesophageal junction or esophagus;
  -  Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria;
  -  Overexpression of EGFR defined by immunohistochemistry (3+) or gene amplification by fluorescence in-situ hybridisation;
  -  Have progressed after one chemotherapy regimen;
  -  Age 18-75 years old with performance status of 0 to 2
  Exclusion Criteria:
  -  Prior targeted therapy with erlotinib, gefitinib, and so on
  -  Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
  -  Known severe hypersensitivity to icotinib or any of the excipients of this product.
  -  Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Relevance to patient case: not relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer

Summary: This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.


Eligibility: Inclusion Criteria:
  -  Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).
  -  Evidence of T790M mutation to enroll in Cohort A.
  -  Evidence of measurable disease by radiographic technique.
  -  Adequate organ function.
  Exclusion Criteria:
  -  Patients with T790M mutation who stopped any prior EGFR-directed therapy without evidence of disease progression.
  -  Symptomatic brain metastases.
  -  Uncontrolled or significant cardiovascular disease.
  -  Pregnant or breastfeeding.

Relevance to patient case: definitely relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: VEGFRs Predict Bevacizumab Benefit in Advanced Non Small Cell Lung Cancer

Summary: a. VEGFRs may be the biomarker which can predict the effect of bevacizumab in non small cell lung cancer

Detailed description: 1. non small cell lung cancer (non squamous carcinoma)
  2. ECOG 0-1
  3. from 18-75 years old

Eligibility: Inclusion Criteria:
  -  non squamous cell non small cell lung cancer
  -  with measurable disease
  -  ECOG 0-1
  Exclusion Criteria:
  - patients received surgery in recent 4 weeks

Relevance to patient case: not relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Analysis of Plasma Tumor DNA in Lung Cancer Patients

Summary: The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in patients with non-small cell lung cancers. Therefore, the detection of altered genetic alterations is useful for predicting the treatment response for TKIs in non-small cell lung cancer patients. However, good quality tumor tissues are available only in <50% of patients with inoperable lung cancer for mutation analysis. In this study, the investigators will detect and quantify the genetic alterations in plasma. the investigators will investigate if the serial measurement of cancer-derived genetic alterations in plasma can provide a means for monitoring disease progression, as well as treatment response. In addition the investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma tumor DNA.


Eligibility: Inclusion Criteria:
  -  Have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer
  -  Have molecular evidence of genetic alterations in tumor sample (eg. EGFR mutations, ALK fusions)
  -  Patients must have given written informed consent
  Exclusion Criteria:
  -  Patients who refuse the blood samplings

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World.

Summary: This is a retrospective, non-interventional, multicenter, observational chart review study to explore the clinical benefits of retreatment with TKI in the real world.

Detailed description: This study is designed to retrospectively review the medical and chemotherapy records of 300 patients with EGFR mutation positive adenocarcinoma NSCLC. Eligible patients are as follows: histologically or cytologically confirmed NSCLC, undergone EGFR-TKI retreatment sometime after the failure of the initial EGFR-TKI. After initial treatment, patients had been treated with chemotherapy and subsequently re-treated with EGFR-TKI will be identified. The target population will be derived from multicentre in Taiwan. The study aim is to evaluate clinical effect in re-administration of EGFR-TKI using retrospectively collected data from these eligible patients to provide valuable information.

Eligibility: Inclusion Criteria:
  1. Patients diagnosed with advanced adenocarcinoma or positive result of thyroid transcription factor 1 NSCLC
  2. Positive Epidermal Growth Factor Receptor mutation result with sensitive mutation
  3. Female or male aged ≧20 years
  4. Patients treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor and subsequently treated with chemotherapy before re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor. Exclusion Criteria:
  1. Patients with EGFR mutation status of positive exon 20 T790M mutation only. 2. Patients who are confirmed of squamous type NSCLC

Relevance to patient case: definitely relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.

Summary: Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety and efficacy of different dosage of Nimotuzumab in second or late- line treatment of patients with locally advanced or metastatic esophageal squamous cell carcinomas.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed esophageal squamous carcinoma,failed to first or second line chemothrepay
  -  Age 18 to 75 years old
  -  Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
  -  Life expectancy of ≥3 month
  -  Karnofsky performance status ≥80
  -  WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>100,000/mm3, Hb>9g/dl，Bilirubin level < 1.0 times ULN，Serum creatinine <1.0 times ULN，ALT and AST<2.5 times ULN ，AKP < 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
  -  No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever＞38℃；
  -  Normal ECG/cardiac function
  -  Good compliance
  -  Having signed informed consent -
  Exclusion Criteria:
  -  No previous systemic therapy for metastatic esophageal squamous carcinoma
  -  Known hypersensitivity to study drugs
  -  Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
  -  No measurable lesions, eg. pleural fluid and ascites
  -  Only with Other previous malignancy within 5 year, except non-melanoma skin cancer
  -  Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
  -  Chronic diarrhea
  -  Mentally abnormal or disable cognition,including CNS metastasis
  -  Pregnancy or lactation period

Relevance to patient case: not relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients

Summary: The purpose of this study is to see whether gene mutations can be found in the urine or blood of lung cancer patients and urine of colorectal cancer patients. Gene mutations are when DNA in a gene is damaged in a way that changes the genetic message carried by that gene. Gene mutations can sometimes cause lung cancers. These gene mutations are only found in lung and colorectal cancer cells, not the normal cells in your body. All lung cancer tumors and colorectal cancer tumors are now tested for different gene mutations as their presence affects lung cancer treatment. Tumor samples obtained from a biopsy or surgery are typically tested for these gene mutations.


Eligibility: Inclusion Criteria:
  Lung cancer:
  For patients participating in Part A (initial testing) and Part B (serial testing):
  -  Patients must have a diagnosis of stage IV lung adenocarcinoma undergoing systemic therapy.
  -  Patients must have had or intend to have EGFR mutation testing (specifically including exon 19 deletions and L858R) performed on their tumor with results available from a CLIA certified laboratory.
  -  ≥ 18 years of age
  Specific to patients participating in Part B (serial testing):
  -  Patients must be planning to receive cancer care at Memorial-Sloan Kettering.
  -  Patients must have a confirmed EGFR mutant lung cancer (exon 19 deletions and L858R) with molecular testing results available from a CLIA certified laboratory.
  -  Must be within 3 months of their diagnosis of metastatic lung cancer.
  -  Treatment plan should include an EGFR tyrosine kinase inhibitor, but may concurrently be on a therapeutic protocol.
  Colorectal Cancer:
  For patients participating in Part A (initial testing) and Part B (serial testing):
  -  Patients must have a diagnosis of stage IV colorectal adenocarcinoma undergoing systemic therapy or have recently progressed on therapy including anti-EGFR based therapy.
  -  Patients must have had or intend to have RAS/RAF mutation testing on their tumor with results available from a CLIA certified laboratory. For the patients who recently progressed on anti-EGFR must have tumor tissue molecular analyses preformed (prior to enrolling or a plan to test it at the time of enrollment).
  -  >18 years of age
  Specific to patients participating in Part B (serial testing):
  -  Patients must be planning to receive cancer care at Memorial-Sloan Kettering.
  -  Patients must have a confirmed RAS/RAF mutant colorectal cancer with molecular testing results available from a CLIA certified laboratory.
  -  Must be within 3 months of their diagnosis of metastatic colorectal cancer.
  Exclusion Criteria:
  lung cancer and colorectal cancer
  -  Comorbidities that would prohibit or make serial urine collection difficult or impossible

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Study of Changes of Lymphocyte Subsets in Chemotherapy Course of Patients With Non-small Cell Lung Cancer

Summary: The purpose of this study is to investigate the changes of lymphocyte subsets in chemotherapy course of patients with non-small cell lung cancer

Detailed description: patients with primary non-small cell lung cancer who received first chemotherapy in Beijing Chaoyang Hospital affiliated to Capital Medical University were collected, and the percentage of lymphocyte subsets at 9 time points before, during, and after chemotherapy was detected by flow cytometry method.We will investigate the changes of patients' lymphocyte subsets in chemotherapy courses. The correlation of the percentage of lymphocyte subsets and age, gender, pathological type, clinical stage, surgery or not, clinical efficacy assessment will be further analyzed.

Eligibility: Inclusion Criteria:
  -  Each Period Non-small Cell Lung Cancer, Which Was Confirmed by Histopathology. patients has only lung cancer .
  -  Functional Status Score (PS) ≧ 70.
  -  The first time for chemotherapy .
  -  A Written Informed Consent.
  Exclusion Criteria:
  -  Merging other tumors.
  -  HAve autoimmune diseases.
  -  AIDS

Relevance to patient case: not relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer

Summary: This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer

Detailed description: This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary endpoint is progression-free survival

Eligibility: Inclusion Criteria:
  -  Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation
  -  No previous systemic anticancer therapy
  -  Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
  -  ECOG Performance Status of 0 to 1
  Exclusion Criteria:
  -  Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab
  -  Evidence of clinically active Interstitial Lung Diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
  -  Known severe hypersensitivity to icotinib or any of the excipients of this product

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Clinical Observation of S1 Capsule for Stage Ⅱ-ⅢA Non-small Cell Lung Cancer After Complete Resection

Summary: The purpose of this study is to evaluate S1 capsule plus Cisplatin as adjuvant treatment in stageⅡ and Ⅲa non-small cell lung cancer. It is the first study in the world to investigate the safety and efficacy of S1 capsule using in stageⅡ and Ⅲa non-small cell lung cancer patients after the complete resection.

Detailed description: Lung cancer is the leading cause of cancer death worldwide. Only about 15.6% of all lung cancer patients are alive 5years or more after diagnosis. Non-small Cell Lung Cancer (NSCLC) accounts for more than 85% of all lung cancer cases.
  For individuals with stage Ⅱ-ⅢA NSCLC after complete resection, platinum-based chemotherapy is the mainstay of first line treatment. Various treatment regimens have been developed to improve survival.
  S-1 capsule is an novel oral anticancer drug that combines tegafur, a prodrug of 5-fluorouracil, with gimeracil and oteracil potassium. S-1 capsule was considered to be an active single agent against NSCLC.

Eligibility: Inclusion Criteria:
  -  Patient with completely resected stage ⅢA non-small cell lung cancer(NSCLC)
  -  Must be able to receive the therapy of the study within four weeks after the completely resection
  Exclusion Criteria:
  -  Systemic anticancer treatment
  -  local radiotherapy

Relevance to patient case: not relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients

Summary: This is a phase IV multicenter trial to evaluate the pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a real-life setting in advanced ALK-positive non-small cell lung cancer (NSCLC) patients.
  NSCLC represent 80% of all new cases of lung cancer. One molecular subtype of NSCLC is the ALK-positive subtype. The anaplastic lymphoma kinase (ALK) is a transmembrane receptor tyrosine kinase. Activation of ALK occurs through the formation of gene fusions and in NSCLC, the gene fusion partner for ALK is primarily EML4. The resulting fusion protein is capable of activating the ALK kinase domain, leading to cell growth. The estimated prevalence for ALK rearrangements in NSCLC is 3-5%, and is more commonly found amongst patients with adenocarcinoma histology, in never smokers and in those who are known to be wild type for EGFR and KRAS.
  Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK+ NSCLC patients. This is an example of personalized medicine, where patients are selected for treatment based upon a molecular assay, and are provided a specific therapy (crizotinib) for their disease. The pharmacoeconomic impact of using genetic information in early treatment decisions in NSCLC has not been determined.
  The study will enable real-life Heath Economics and Outcome Research (HEOR).
  Approximately 90 patients will be recruited. Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib.


Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed locally advanced or metastatic NSCLC
  -  Presence of the ALK-fusion oncogene (ALK+) as determined using a validated testing platform
  -  Planned first or second-line treatment with crizotinib
  -  Signed and dated IRB-approved informed consent document
  -  Ability to read and understand English or French
  -  18 years of age or older

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC

Summary: The purpose of this study is to determine whether EGFR-TKI can control the development of intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain metastases, and the difference in progression free survival between exon 19 and exon 21 mutations.

Detailed description: A open, positive control of phase II clinical trials, divided into selection period, treatment period and follow-up period , comply with the standard set of participants signed a written informed consent, according to different divided into 19 patients with EGFR mutations outside show son mutation group) and 21 extra show mutations, and according to the ECOG physical status, age, previous systemic treatments such as hierarchical analysis, regular follow-up and to assess efficacy, life care and safety.

Eligibility: Inclusion Criteria:
  1. at the age of 18 -70 years old, male or female
  2. the non-small cell lung cancer diagnosed by histopathology
  3. detected by ARMS to confirm that the EGFR sensitive mutant patients
  4. the existence of MRI diagnosis of intracranial metastatic head enhancement, and the presence of imaging evaluating lesions (according to RECIST1.1)
  5. have not received prior treatment of intracranial metastases, including radiotherapy, gamma knife, chemotherapy drugs
  6. no brain metastasis symptoms, including, increased intracranial pressure, no vomiting, ignoring the papillary edema, no headache, without hemiplegia, ignore things not clear, without epilepsy
  7. PS:0 or 1
  8. the expected survival time 3 months &gt;
  9. patients signed informed consent voluntarily
  Exclusion Criteria:
  1. 4 weeks before entering the group received operation or operation, the wound has not healed completely
  2. into group 2 weeks before receiving immune therapy or treatment of traditional Chinese Medicine
  3. serious cardiovascular diseases, including Department of internal medicine, uncontrolled hypertension, unstable angina, myocardial infarction history exists within the past June, severe arrhythmia or pericardial effusion
  4. serious infection, need intravenous antibiotic, antifungal or antiviral treatment
  5. before entering the group 4 weeks participated in any study drug clinical trial
  6. there are serious tumor invasion, oppression by the main bronchus or bronchial stenosis or obstruction, superior vena cava syndrome
  7. the existence of herniation of brain tumor apoplexy, epilepsy, and frequent
  8. suffering from a mental illness, poor compliance
  9. the researchers think that do not fit into the group of cases

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer

Summary: Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.


Eligibility: Inclusion Criteria:
  -  Patients undergoing completely resection of EGRF mutation-positive NSCLC
  -  Staging ⅠB (with high risk factor) to ⅢA
  -  PS＜2
  -  Adequate hematological, biochemical and organ functions.
  Exclusion Criteria:
  -  Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating.

Relevance to patient case: possibly relevant