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

Clinical trial: A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Summary: This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.


Eligibility: Inclusion Criteria:
  -  Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
  -  Measurable disease according to RECIST
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Life expectancy greater than or equal to (>/=) 12 weeks
  -  Adequate hematological, liver and renal function
  -  Participants with asymptomatic and stable cerebral metastases receiving medical treatment
  Exclusion Criteria:
  -  Previous chemotherapy or treatment against EGFR for metastatic disease
  -  Treatment with an investigational agent less than 3 weeks before enrollment
  -  History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
  -  Participants with symptomatic cerebral metastases
  -  Any significant ophthalmologic abnormality
  -  Unstable systemic disease
  -  Coumarins use
  -  Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
  -  Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
  -  Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)

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

Clinical trial: VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung Cancer

Summary: Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.

Detailed description: Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.This is a multicenter, prospective study, aimed To evaluate the short-term and long- term outcome of VATS major lung resection for early stage lung cancer. Patients will be followed up every 3 months for 3 years.

Eligibility: Inclusion Criteria:
  Preoperative criteria:
  i) non-small cell lung cancer is suspected, ii) clinical stage I/II (3) Intraoperative criteria: i) Histologically confirmed NSCLC, ii) resected by VATS or converted open lobectomy,sleeve lobectomy or pneumonectomy and nodal dissection/sampling.
  (4) No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
  (5) No prior chemotherapy or radiation therapy for any malignant diseases. (6) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr. (7) Performance status of 0 or 1. (8) Sufficient organ functions. (9) Written informed consent.
  Exclusion Criteria:
  1. Active bacterial or fungous infection.
  2. Simultaneous or metachronous (within the past 5 years) double cancers.
  3. Women during pregnancy or breast-feeding.
  4. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
  5. Psychosis.
  6. Systemic steroids medication.
  7. Uncontrollable diabetes mellitus.
  8. Uncontrollable hypertension.
  9. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.

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

Clinical trial: Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21

Summary: Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin with concurrent radiotherapy.


Eligibility: Inclusion Criteria:
  -  NSCLC confirmed by histopathology or cytology;
  -  Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung Staging Standard version 7 2009, and be unresectable;
  -  Has active mutation of EGFR in exon 19 or 21;
  -  Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
  -  expectancy life >= 12 weeks;
  Exclusion Criteria:
  -  Had be treated by HER-targeting agents;
  -  Had systemic anit-NSCLC treatments;
  -  Had local radiotherapy for NSCLC;
  -  Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
  -  Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
  -  Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
  -  Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI) agents or relevant components in the formulation;
  -  Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;

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

Clinical trial: Observational Study to Characterize the Incidence of EGFR Mutation Positive and Advanced NSCLC Patients

Summary: The present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations and their clinical management in Galicia.


Eligibility: Inclusion Criteria:
  Inclusion Criteria for patients´ screening:
  -  Patients of both sexes aged 18 or more.
  -  Histologically confirmed advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) (patients stage III B unsuitable for locoregional treatment, and stage IV).
  -  Chemo- naïve patients (Non-Small-Cell Lung Cancer patients who have not received first line systemic cytotoxic chemotherapy).
  -  Patients with available tumoral tissue (primary tumor or metastatic area) or cytological samples including fine needle aspirates (primary tumor or metastatic area), bronchial alveolar lavage or bronchial scrapings and pleural effusion.
  -  Patients who have granted their written informed consent.
  Patients must fulfill the inclusion criteria previously mentioned and the following one in order to be enrolled in the study (visit 1) for the follow-up until progression or until 9 months from the beginning of treatment have elapsed:
  Inclusion Criteria for patients´ follow-up
  -  Patients with documented positive mutation in epidermal growth factor receptor (EGFR) (M+).
  Exclusion Criteria:
  -  Combined histology of non-small cell and 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: C11-Erlotinib PET/CT as a Tool for Identification and Characterization of Tumor With High Expression of Epidermal Growth Factor Receptor(EGFR).

Summary: The EGFR is one of the most frequently overexpressed proteins in various cancers including lung cancer, and is related to tumor progression and resistance to most treatments.
  New treatment strategies targeting EGFR have been developed: "although much work remains to be done, erlotinib has already established itself as part of the therapeutic armamentarium against cancer"(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ. Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.)
  Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could aid in the selection of patients for individualized therapy with EGFR kinase inhibitors.
  Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant tumor burden before the initiation of therapy with EGFR inhibitors.
  The purposes of the study are:
  1. To adjust an optimal treatment for patients with tumors that have high expression of EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during pretreatment work-up; as well as to follow up after treatment response.
  2. To recognize patients with advanced pancreatic cancer responding to treatment with erlotinib and to distinguish them from non-responders.


Eligibility: Inclusion Criteria:
  -  patients with NSC type of lung cancer with high expression of EGFR who are candidates for erlotinib as second / third line of treatment;
  -  patients with advanced pancreatic tumor who are candidates for complex gemcitabine and erlotinib treatment.
  Exclusion Criteria:
  -  lack of histological diagnosis;
  -  not a candidate for erlotinib;
  -  pregnancy.

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

Clinical trial: Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients

Summary: The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.

Detailed description: This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.

Eligibility: Inclusion Criteria:
  -  Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
  -  Positive EGFR 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.
  -  Provision of written informed consent.
  Exclusion Criteria:
  -  Experience of 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.
  -  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: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations

Summary: This observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in clinical practice according to RECIST criteria
  -  EGFR mutation-positive disease according to local laboratory testing
  -  Patients on treatment with Tarceva monotherapy as first-line treatment according to the physician's usual practice
  Exclusion Criteria:
  -  Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it was finalized >6 months prior to receiving Tarceva
  -  Participation in another clinical study
  -  Patients could have received radiotherapy as long as the irradiated lesion was not the only lesion for evaluating response and a long as the radiotherapy was completed before initiating Tarceva treatment

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

Clinical trial: Detecting EGFR T790M Mutations From Circulating Tumor Cells

Summary: The purpose of this research study is to determine if the EGFR mutation can be detected in CTCs. CTCs are cancer cells that are shed from solid tumors and float freely in the bloodstream. A device called the CTC-chip has been developed to find CTCs in the blood of patients with cancer. This is an experimental device. Using this device, the investigators will test participants' blood to try and find CTCs with the EGFR mutation and compare them with the results from the biopsy your doctor has recommended. The long-term goal of this research is to develop a way to test for the EGFR mutation that is less invasive than a tumor biopsy.

Detailed description: In order to participate in this study you need to have a diagnosis of NSCLC that has spread or is unable to be surgically removed. In addition, your cancer must have an EGFR mutation and you must have a scheduled (or recently performed) biopsy to check on the presence of any other mutations related to targeted drug resistance.
  After you sign consent to participate in this study we will draw a blood sample (three tubes of blood). This is about 6 teaspoons of blood.
  The number of CTCs in your blood will not be reported to you since it is not known if this number has any meaning or if it impacts your medical care in any way. These results will not become part of your medical record. They will be kept in a separate, secure location.
  We will collect information from your medical records and store it in a research record that we create about you. The study team will use this information to compare details about your medical history with the results of the experiments done on your blood.
  Genetic material (DNA) will be removed from the CTCs found in your blood. This genetic material will be stored at the Massachusetts General Hospital and studied along with samples from other participants on this research study. Your samples will not be labeled with your name or any information that identifies you. Your samples will have a study-specific code number on them. The code linking your name to the sample will be kept in a secure location, available only to the investigators of the study and select study team members.
  After the blood draw we will follow your status every 6 months by reviewing your medical records.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed NSCLC that is metastatic or unresectable
  -  Have agreed to undergo a clinically recommended invasive repeat tumor itssue biopsy
  Exclusion Criteria:
  -

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

Clinical trial: ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

Summary: This is a multinational, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of treatment with dacomitinib (PF-00299804) to treatment with gefitinib in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal growth factor receptor EGFR-activating mutation (s). Analyses of primary objective (Progression Free Survival) will be done as defined in the protocol.

Detailed description: 452 patients were randomized in a 1:1 ratio between dacomitinib (PF-00299804 ) vs. gefitinib.

Eligibility: Inclusion Criteria:
  -  Evidence of histo or cytopathology confirmed, advanced NSCLC (with known histology) with the presence of EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21).
  -  It is acceptable for subjects with the presence of the exon 20 T790M mutation together with either EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21) to be included in this study
  -  Minimum of 12 months disease free interval between completion of systemic therapy and recurrence of NSCLC
  -  Adequate tissue sample must be available for central analyses.
  -  Adequate renal, hematologic, liver function.
  -  ECOG PS of 0-1.
  -  Radiologically measurable disease.
  Exclusion Criteria:
  -  Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer.
  -  Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation.
  -  Any history of brain mets or leptomeningeal mets.
  -  Any previous anti-cancer systemic treatment of early, locally advanced, or metastatic NSCLC.
  -  Uncontrolled medical disorders.

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

Clinical trial: Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

Summary: To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.


Eligibility: Inclusion Criteria:
  -  1. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent
  Exclusion Criteria:
  -  1. Active infection 2. Active bleeding

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

Clinical trial: Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer

Summary: The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.

Detailed description: The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.

Eligibility: Inclusion Criteria:
  -  Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry.
  -  Aged 18~75 years
  -  Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown
  -  With at least one measurable lesion
  -  White blood cell count≥4×10^9/L,platelet count≥100×10^9/L and hemoglobin≥11g/L
  -  Life expectancy ＞3 months
  -  Eastern Cooperative Oncology Group performance status of ≤1 at study entry
  -  Women of childbearing age should have pregnancy test negative and would like to conduct birth control during the study
  -  Have signed informed consent
  Exclusion Criteria:
  -  Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or ≥Grade 2 sino-auricular heart-block,or ≥Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug
  -  The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period
  -  Organ transplant patients
  -  Patients with active bleeding or new thrombotic diseases
  -  Patients with body temperature ＞38.5℃ for more than 3 days
  -  Total bilirubin ＞1.5 fold of upper limit of normal (ULN), ALT/AST＞1.5 fold of ULN or serum creatine ＞1.5 fold of ULN
  -  Patients with symptomatic brain-metastasis
  -  Pregnant or lactating women
  -  Patients with mental disorder

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

Clinical trial: Genetics of EGFR (Epidermal Growth Factor Receptor) Mutation Study

Summary: The investigators wish to document the distribution of EGFR somatic mutations, and assess the relationship between specific genotype, clinical demographic, therapy, and survival, in a large cohort of EGFR mutant NSCLC.
  The investigators also wish to comprehensively investigate the relationship between germline DNA and risk of EGFR mutant NSCLC developing, through a GWAS (Genome-Wide Association Studies) and candidate gene approach, and explore the relationship between germline DNA and clinical outcome, in order to potentially identify germline genetic modifiers of EGFR TKI (Tyrosine Kinase Inhibitor) outcome.

Detailed description: Objective 1: To identify germline allelic DNA variation associated with somatic EGFR mutation in NSCLC, Objective 2: Correlation between germline allelic variants and survival in EGFR somatic mutant NSCLC.
  Objective 3: Study germline allelic DNA variation associated with never /ex light smoking NSCLC.
  Objective 4: Catalogue distribution of somatic EGFR mutant genotypes in 1,000 EGFR mutant NSCLC cases and describe their relationship to clinical outcome.

Eligibility: -  Histologically or cytologically diagnosed NSCLC, all histologies are acceptable.
  -  Patients can be included in the study with any disease stage and at any time during the disease course.
  -  Any type (surgery, RadioTherapy, chemotherapy, targeted agents) of previous treatment and any line of treatment are eligible.
  -  Age ≥18 years.
  Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial.
  Before patient registration, written informed consent must be given according to ICH/GCP (International Conference on Harmonisation/Good Clinical Practice), and national/local regulations.

Relevance to patient case: possibly relevant