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

Clinical trial: Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer

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 trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. The Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy and radiotherapy in patients with advanced nasopharyngeal cancer.

Detailed description: Patients with advanced nasopharyngeal cancer will be randomized to 2 arms. The patients in experimental arm will be treated with Nimotuzumab which will be used concurrently with radiotherapy and chemotherapy. The chemotherapy regimen were Cisplatin monotherapy. The active comparator arm will be administered chemotherapy and radiotherapy only. The dose and regimen were the same with experiment arm. The patients'hematopoietic , hepatic and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed at the first and the fourth month, and followup every six months to evaluate the survival index in three years after the study.

Eligibility: Inclusion Criteria:
  -  Joined the study voluntary and signed informed consent form
  -  Age 18-70，both genders.
  -  Nasopharyngeal cancer was confirmed by pathology.
  -  Nasopharyngeal cancer 2008 Stages: Ⅲ/Ⅳa.
  -  Primary lesions can measurable.
  -  Karnofsky Performance Scale >70.
  -  Life expectancy of more than 6 months.
  -  Use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
  -  Haemoglobin≥100g/L ,WBC ≥4×109/L, platelet count≥100×109/L
  -  Hepatic function:ALAT、ASAT< 1.5 x ULN, TBIL< 1.5 x ULN
  -  Renal function: Creatinine < 1.5 x ULN
  Exclusion Criteria:
  -  Evidence of distant metastasis
  -  Primary lesions or lymph node have been operated (except of operation for biopsy)
  -  Previous radiotherapy
  -  Received other anti EGFR monoclonal antibody treatment
  -  Previous chemotherapy or immunization therapy
  -  Other malignant tumor (except of Non-melanoma Skin Cancer or carcinoma in situ of cervix)
  -  Participation in other interventional clinical trials within 1 month
  -  Peripheral neuropathy is more than I stage
  -  Pregnant or breast-feeding women and women who refused to take contraceptive method
  -  History of serious allergic or allergy
  -  History of Serious lung or heart disease
  -  Refused or can't signed informed consent form
  -  Drug abuse or alcohol addiction
  -  Personality or psychiatric disease, and persons without capacity for civil conduct or persons with limited capacity for civil conduct

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

Clinical trial: Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)

Summary: Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.

Detailed description: Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by Erlotinib 150 mg/day consolidation treatment.

Eligibility: Inclusion Criteria:
  -  Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
  -  Tumor EGFR mutation
  -  Presence of measurable disease by RECIST
  -  stage IIIA or IIIB, non-resectable
  -  ECOG performance status 0-2
  -  No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
  -  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:
  -  Carcinoid tumor, small cell carcinoma of lung
  -  Patients with any distant metastasis
  -  History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  -  Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
  -  Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
  -  Women and men of childbearing potential who have no willing of employing adequate contraception
  -  Tumor EGFR wild

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 Non-interventional Survey on the EGFR (Epidermal Growth Factor Receptor) Mutation Status in Completely Resected Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Adenocarcinoma Histology

Summary: This is a descriptive observational study. The primary objective is to explore the EGFR gene mutation status in early stage NSCLC with adenocarcinoma histology after complete resection. The patients should be histological confirmed adenocarcinoma of the lung, have received complete resection and tested for EGFR mutation in regular medical practice.


Eligibility: Inclusion Criteria:
  -  Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
  -  Have completed lung cancer operation
  -  The tumour EGFR gene mutation status test was performed as regular medical practice
  Exclusion Criteria:
  -  Patients who disagree to participate this study

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

Clinical trial: Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is studying biomarkers in blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.

Detailed description: OBJECTIVES:
  -  To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501.
  -  To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen.
  OUTLINE: This is a multicenter study.
  DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of refractory non-small cell lung cancer
  -  Received sorafenib tosylate on protocol ECOG-E2501
  -  Available blood specimens
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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 Non-interventional Study (NIS) Registry for the Epidemiological and Scientific Evaluation of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) (Stage IIIB/IV Non-small Cell Lung Cancer).

Summary: The primary objective of the study is to collect epidemiological data on EGFR mutation status [M+(mutation positive), M-(mutation negative)] in a population of predominantly Caucasian ethnicity, and to correlate EGFR mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and non-adenocarcinoma).


Eligibility: Inclusion Criteria:
  1. Signed written informed consent.
  2. Female or male aged 18 years or above.
  3. Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV).
  4. Patients receiving 1st-line treatment for IIIB/IV NSCLC.
  5. Patients with known EGFR mutation status (i.e. patients must be either EGFR M+, EGFR M- or EGFR Mx).
  6. Tumour not amenable to curative surgery or radiotherapy.
  Exclusion Criteria:
  1. Mixed histology of small cell and non-small cell lung cancer.

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

Clinical trial: Concurrent Endostar, Paclitaxel/Carboplatin and Radiotherapy for Locally Advanced Non-small Cell Lung (RT0902)

Summary: Concomitant chemoradiotherapy is the standard treatment of locally advanced, non-resectable, non-small cell lung cancer (NSCLC). However, the optimal chemotherapy regimen is still controversial. The purpose of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Endostar (Recombinant Human Endostatin), Paclitaxel/Carboplatin and radiotherapy for LA-NSCLC, and also assess its impact on patient Quality of Life (QoL) and progression-free survival (PFS).

Detailed description: Patients with non-resectable non-small Cell Lung Cancer will receive thoracic radiation therapy 60-66 Gy over 30-33 fractions and concurrent with Endostar 7.5 mg/m2 over 3 hours d1-14, Paclitaxel 50 mg/m2 weekly over 1 hour, Carboplatin AUC = 2 mg/mL/min over 30 min weekly. Followed by Endostar 7.5 mg/m2 d1-14,Paclitaxel 175 mg/m2 d1 and Carboplatin AUC = 5 mg/mL/min d1 every 3 weeks for 2 cycles as consolidation treatment.

Eligibility: Inclusion Criteria:
  -  Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
  -  Presence of measurable disease by RECIST
  -  stage IIIA or IIIB, non-resectable
  -  ECOG performance status 0-1
  -  No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy .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:
  -  Carcinoid tumor, small cell carcinoma of lung
  -  Patients with any distant metastasis
  -  History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  -  Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
  -  Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
  -  Women and men of childbearing potential who have no willing of employing adequate contraception Tumor EGFR wild

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

Clinical trial: Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib

Summary: The purpose of this study is to measure the ability of erlotinib to effectively treat recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with erlotinib or gefitinib received in the post-surgical or post-radiation setting.


Eligibility: Inclusion Criteria:
  -  A history of stage I-IIIB NSCLC
  -  Previously underdone definitive surgery or radiation
  -  Received prior adjuvant treatment or neoadjuvant with erlotinib or gefitinib for a total of at least 3 months at any time
  -  Stopped adjuvant erlotinib or neoadjuvant at least 2 months prior to date of first imaging demonstrating recurrence
  -  Pathologic evidence of recurrent lung cancer, confirmed at MSKCC EGFR sensitizing mutation (point mutation in exons 18 or 21, or deletion in exon 19) must be documented in the primary or recurrent tumor
  -  Tissue from their recurrent tumor must be submitted for EGFR mutation testing, and to evaluate for the presence of the T790M mutation (results do not need to have been reported to be eligible)
  -  Measurable disease by RECIST; if received prior irradiation, then must have a target lesion outside the irradiated field
  -  Signed informed consent
  -  Age > or = to 21 years old
  -  Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped
  Exclusion Criteria:
  -  Prior progressive disease while receiving erlotinib or gefitinib therapy
  -  Patients with known pre-existing interstitial lung disease
  -  Total bilirubin greater than 1.8 mg/dl, excepting patients known to have Gilbert's syndrome
  -  AST or ALT greater than five times the upper limit of normal
  -  Pregnant or lactating women
  -  Medically unfit for erlotinib therapy as determined by treating oncologist

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

Clinical trial: Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer

Summary: This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutations.
  Expanded acronym : [P]aclitaxel/Ca[r]boplatin (PC) followed by Gef[i]tinib in A[d]vanc[e]d Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.

Detailed description: A randomized phase II trial that compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with NSCLC without EGFR mutations. While previous studies with cytotoxic agents and gefitinib failed to show any benefit, we altered the schedule of administration in hopes to gain synergy between agents.

Eligibility: Inclusion Criteria:
  -  More than 18 years of age
  -  Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion.
  -  At least 1 measurable lesion as defined by RECIST1.0. All target lesions must have a unidirectional diameter of at least 1cm. Baseline measurements must be compared within 4 weeks prior to enrollment.
  -  ECOG PS 0-2
  -  At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
  -  Patients must have adequate hematologic, renal and liver function as defined by Hb > 9g/dL, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dL, and AST (SGOT) and/or ALT (SGPT) < 5 x UNL (upper normal limit).
  -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
  -  Written and voluntary informed consent understood, signed and dated.
  Exclusion Criteria:
  -  Patients with tumor harboring EGFR mutation.
  -  Prior systemic therapy for NSCLC
  -  Non-smoking patients with adenocarcinoma. But if those patients show wild type EGFR, they are eligible to this study.
  -  Symptomatic brain metastasis. Brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
  -  Major surgery within 3 weeks prior to study enrollment.
  -  Previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
  -  Severe medical illness or active infection that would impair the ability to receive gefitinib.
  -  Pregnancy or breast feeding.

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 Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations

Summary: This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/=18 years of age
  -  Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
  -  Measurable disease according to RECIST criteria
  -  ECOG performance status 0-2
  -  Adequate haematological, renal and liver function
  Exclusion Criteria:
  -  Previous chemotherapy or therapy against EGFR for metastatic disease
  -  History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
  -  Symptomatic cerebral metastases
  -  Pre-existing parenchymal lung disease such as pulmonary fibrosis
  -  Concomitant use of coumarins

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

Clinical trial: Biomarkers in Predicting Response in Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy

Summary: This research trial studies prognostic and predictive markers in patients with early stage non-small cell lung cancer receiving chemotherapy. Prognostic markers are patient or tumor factors that predict patient survival independent of treatment. Predictive markers are factors that may influence and predict the outcome of treatment in terms of either response or survival benefit. Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. Evaluate potential prognostic and predictive markers in patients receiving adjuvant chemotherapy for early stage non-small cell lung cancer (NSCLC).
  II. To perform cross-validation analyses for the predictive value of cyclin-dependent kinase inhibitor 1B (p27), excision repair cross-complementation group 1 (ERCC1), beta-tubulin and B-cell lymphoma 2 (BCL2)-associated X protein (BAX).
  III. To perform cross-validation analyses for the prognostic value of mucin and breast cancer (BRCA)1 expression.
  IV. To perform a pooled analysis for the prognostic impact of p53 protein expression by immunohistochemistry (IHC), tumor protein p53 (p53) mutation, ras mutation and epidermal growth factor receptor (EGFR) mutation, and Fas cell surface death receptor (Fas)/Fas ligand (FasL) expression by IHC.
  V. Validation of the 15-gene prognostic and predictive messenger ribonucleic acid (mRNA) signature on Lung Adjuvant Cisplatin Evaluation (LACE)-Bio formalin-fixed paraffin-embedded (FFPE) tumor samples.
  VI. Exploratory evaluation of the prognostic and predictive values of known potential oncogenic mutations using LACE-Bio FFPE.
  VII. Exploratory evaluation of the prognostic and predictive values of gene copy variation using LACE-Bio FFPE tumor samples.
  VIII. Exploratory identification and evaluation of prognostic and predictive value of novel genomic aberrations discovered by Next Generation Sequencing on LACE-Bio tumor samples.
  OUTLINE:
  Previously collected tissue samples are analyzed by IHC.

Eligibility: Inclusion Criteria:
  -  Registration to CALGB9633 for this study
  -  Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
  -  Informed consent:
  -  The subject population to be studied in this protocol includes patients selected from CALGB 9633 for whom an available specimen is present at the Alliance Ohio State University (OSU); all such patients have signed a written informed consent document meeting all federal, state, and institutional guidelines as part of entry into that trial
  -  Only cases with adequate tumor formalin FFPE material without depleting the available clinical block(s) are eligible

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 Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

Summary: This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.


Eligibility: Inclusion Criteria:
  -  Adult participants, >/= 18 years of age
  -  Stage IV or recurrent non-small cell lung cancer (NSCLC)
  -  Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)
  -  Measurable disease (at least one lesion >= 10 mm in longest diameter)
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Adequate hematological, renal and liver function
  Exclusion Criteria:
  -  Patients with T790M single mutation only
  -  Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. erlotinib, gefitinib, cetuximab, trastuzumab
  -  Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease
  -  Symptomatic or uncontrolled central nervous system (CNS) metastases
  -  Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast
  -  Any significant ophthalmologic abnormality
  -  Pre-existing parenchymal lung disease such as pulmonary fibrosis
  -  Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead)

Relevance to patient case: possibly relevant