araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

Summary: This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.


Eligibility: Inclusion criteria:
  -  Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
  -  Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material.
  -  Measurable disease according to RECIST 1.1.
  -  Eastern Cooperative Oncology Group score of 0 or 1.
  -  Age >/= 18 years.
  -  Life expectancy of at least three months.
  -  Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice guidelines.
  Exclusion criteria:
  -  Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
  -  Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies.
  -  Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.
  -  Active brain metastases
  -  Any other current malignancy or malignancy diagnosed within the past five years
  -  Known pre-existing interstitial lung disease.
  -  Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
  -  History or presence of clinically relevant cardiovascular abnormalities.
  -  Any other concomitant serious illness or organ system dysfunction.
  -  Adequate absolute neutrophil count and platelet count
  -  Adequate liver and kidney function
  -  Active hepatitis B infection, active hepatitis C infection or known HIV carrier.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Erlotinib Concurrent With Radiation Therapy in Non-small-cell Lung Cancer

Summary: The purpose of this study is to determine the safety and efficacy of the concurrent use of erlotinib and radiation therapy in the treatment of locally advanced non-small lung cancer.

Detailed description: Non-small cell lung cancer (NSCLC) is still the leading cause of cancer death world-wide. Radiation therapy (RT) is one of the most important treatment choices in locally advanced NSCLC. Combination of RT and chemotherapy could improve treatment outcomes. However, the combined modality could not be used in many patients due to severe toxicities. EGFR-TKI shows great efficacy in the treatment of NSCLC, and many phase I/II studies established its safety in combination with RT. This phase II study is to further evaluate the efficacy and safety of the combination of RT and erlotinib in the treatment of locally advanced NSCLC. Eligible patients include patients with stage IIIA/IIIB NSCLC, who are not suitable for or refused to receive concurrent chemoradiotherapy. Eligible patients will receive oral erlotinib (150mg qd)throughout the course of thoracic RT (60-70 Gy). The primary endpoint is progression free survival and the second endpoints are overall survival and any grade III and above toxicities. We are going to recruit 50 patients for this study.

Eligibility: Inclusion Criteria:
  -  Aged 18-70 years，
  -  Patients with stage IIIA-IIIB NSCLC
  -  adequate hematologic (WBC and platelet counts within normal limits), hepatic (total bilirubin level <= two times the upper limit of normal), and renal (creatinine clearance >= 50mL/min) functions
  -  No history of chemotherapy or less than 4 cycles neoadjuvant chemotherapy
  -  Can not tolerate or refuse concurrent chemoradiotherapy
  -  No history of thoracic RT
  -  Written informed consent obtained
  Exclusion Criteria:
  -  With other malignancy
  -  With severe cardiopulmonary disease
  -  Compromised liver or renal function that could not tolerate the combined therapy
  -  Received thoracic RT before
  -  Pregnant or breast-feeding women
  -  Present with active infection
  -  Uncontrolled diabetes
  -  Concurrent use of other anti-cancer agents

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Gene Mutations in Non-Small Cell Lung Cancer Cells

Summary: To compare the frequency of individual genetic abnormality between tumor cells and blood specimens.

Detailed description: Samples will be collected before the systemic therapy. After initiation of therapy, samples will be collected at end of the 1st month, at the end of the 2nd month at the end of 3rd months and once every three months thereafter concurrently with the tumor assessment such as time of performing CT scans. In selected consented patients, peripheral blood samples will be collected every week for the first month.
  Disease status will be assessed every 2~3 months and at the end of treatment according to RECIST criteria. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy. Progression-free survival, overall survival and response rate will be reported.

Eligibility: Inclusion Criteria:
  -  Pathologic or cytological confirmation of NSCLC.
  -  Patients must understand and provide written informed consent prior to initiation of any study-specific procedures.
  -  Have a life expectancy 3 months.
  -  Have malignant pleural/pericardial effusion or metastatic non-small cell lung cancer.
  -  Have measurable or evaluable disease.
  -  ≥20 years.
  -  Candidate for systemic treatment such as EGFR-TKI or chemotherapy.
  Exclusion Criteria:
  -  Prior history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry.

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Epidermal Growth Factor Receptor (EGFR) Status Based Gefitinib Neoadjuvant Therapy in Non Small Cell Lung Cancer (NSCLC)

Summary: This study aims to investigate the efficacy and safety of gefitinib as neoadjuvant therapy in stage IIIA NSCLC patients.


Eligibility: Inclusion Criteria:
  -  Patients pathological diagnosed with NSCLC,with EGFR sensitive mutation;
  -  Stage IIIA patients with technical operable disease evaluated by image and lab results;
  -  Patients without chemotherapy or targeted-therapy before;
  -  Inform Consent.
  Exclusion Criteria:
  -  Patients with malignant tumor other than lung cancer;
  -  Patients with other diseases such as cardiovascular disease that may hamper follow up;
  -  Patients that may not coordinate well,judged by researcher.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib

Summary: The primary objective of this trial is to identify the Maximum Tolerated Dose of BIBW 2992 therapy when given continuously in combination with Sirolimus.
  The MTD will be based on the Dose Limiting Toxicity information collected during the first two cycles.
  Overall safety, pharmacokinetics and anti-tumour efficacy will be evaluated as secondary objectives.


Eligibility: Inclusion criteria:
  1. Pathologically or cytologically confirmed diagnosis of Stage IIIB or Stage IV NSCLC
  2. Patients who have failed conventional treatment (at least 1 prior treatment line), or for whom no therapy of proven efficacy exists
  3. Patients whose tumors:
  -  are EGFR mutation-positive or
  -  are EGFR mutation-negative or unknown provided they had disease progression after achieving either response or stable disease for at least 6 months from a previous treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
  4. Patients aged 18 years or older
  5. Life expectancy of at least three (3) months
  6. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0-2
  7. Written informed consent that is consistent with ICH-GCP guidelines
  Exclusion criteria:
  1. Prior major surgery, chemotherapy or radiation therapy within 4 weeks before start of therapy.
  2. Prior treatment with an mTOR inhibitor within the past 4 weeks before start of therapy or concomitantly with this study
  3. Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of run-in treatment with Sirolimus
  4. Active CNS metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids)
  5. Severe alteration in serum fasting cholesterol (equal or more than 350 mg/dL) or triglycerides (equal or more than 400 mg/dL). Patients may be allowed to enrol on the trial after initiation of lipid lowering agents.
  6. Requirement for treatment with any of the prohibited concomitant medications:
  -  Concomitant CYP3A4 inhibitors within the past 7 days before start of therapy or concomitantly with this study.
  -  Concomitant CYP3A4 inducers within the past 14 days before start of therapy or concomitantly with this study.
  7. Any contraindications for therapy with Sirolimus.
  8. Known hypersensitivity to BIBW 2992, Sirolimus or other rapamycin analogues (everolimus, temsirolimus, deforolimus, etc.) or the excipients of any of the trial drugs.
  9. Use of any investigational drug within 4 weeks before start of therapy.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

Summary: A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

Detailed description: Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard therapy.
  Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.

Eligibility: Inclusion Criteria:
  -  Patients with locally advanced or metastatic non-small cell lung cancer.
  -  Patients must be >/= 18 years of age.
  -  Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.
  Exclusion Criteria:
  -  Patients with a recent history (within 5 years) of another malignancy.
  -  Patients who are pregnant or nursing.
  -  Patients with clinically significant heart failure.
  -  Patients with clinically significant eye or gastrointestinal abnormalities.

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or m

Summary: The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) 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).

Detailed description: An NIS Registry for the Epidemiological and Scientific evaluation of EGFR mutation status in patients with newly diagnosed locally advanced or metastatic NSCLC (stage IIIB/IV non-small cell lung cancer)

Eligibility: Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV). Mixed histology of small cell and non-small cell lung cancer

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Assisted-VATS Sleeve Lobectomy for Non-small Cell Lung Cancer

Summary: The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.

Detailed description: Sleeve lobectomy is removal of a portion of a main stem bronchus in continuity with the adjacent lobe or bilobe followed by end-to-end bronchial anastomosis. The first reported bronchial sleeve resection was performed in 1947 at the Brompton Hospital in London, England, by Sir Clement Price Thomas. Whether sleeve resection is radical enough and indicated for patients who could tolerate pneumonectomy continues to be debated, although many recent reports have suggested that sleeve resection can achieve adequate curability rates. However, sleeve lobectomy has a definite role in the surgical management of lung cancer for patients whose pulmonary reserve is considered inadequate to permit pneumonectomy, and should be used anytime it is possible to achieve a margin-negative (R0) resection.
  Although video-assisted thoracic surgery (VATS) is regarded as a minimally invasive procedure with good long-term survival results, many surgeons think that VATS is too complex and has too many technical limitations to be applied to bronchoplasty. Therefore, there are few reports in the literature of VATS bronchoplasty for lung cancer. The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed non-small cell lung cancer (Squamous, adenosquamous, large cell, or poorly differentiated)
  -  Patients with central tumors located at the origin of a lobar bronchus.
  -  ECOG performance status 0-1
  -  Hematopoietic: WBC at least 4,000/mm^3; Platelet count at least 100,000/mm^3
  -  Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN
  -  Renal: Creatinine clearance greater than 60 ml/min
  -  Cardiovascular: Cardiac function normal
  Exclusion Criteria:
  -  Severe complications or infections
  -  Pregnant or breast-feeding women
  -  Clinically significant heart disease
  -  Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
  -  Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations

Summary: This is a randomized controlled trial to compare efficacy and safety between erlotinib and gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was progression-free survival (PFS).

Detailed description: Patients with stage IV NSCLC who have EGFR exon 19 or 21 mutations will randomized to received oral erlotinib 150mg or gefitinib 250mg once daily until disease progression or unacceptable toxicity. Method of direct DNA sequencing of tumor tissue is used to analysis EGFR mutation status of exons 18-21. The response will be evaluated by RECIST criteria first month,second month and then repeat every 3 months after the beginning of the treatment weeks.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed stage IIIB (wet) or IV NSCLC.
  -  Patients with positive EGFR exon19 or exon21 mutation as confirmed by direct sequencing histologically.
  -  Signing the informed consent form.
  -  The vital organ functions are tolerant to therapy.
  -  Have recovered to CTCAE2 grade below from toxicity of previous chemotherapy and radiotherapy
  -  PS 0-2 scores.
  -  Functional reserve of bone marrow is adequate, e.g. white blood cell count ≥3.0×109/L, planet count ≥90×109/L, and HB≥80×109/L.
  -  Serum bilirubin is 2 times less than the upper limit of normal (ULN), ALT and AST are 3 times less than ULN; for liver metastases, ALT and AST need to be 5 times less than ULN; creatinine should be 2 times less than ULN.
  Exclusion Criteria:
  -  Informed consent is not provided.
  -  Women of pregnancy or breastfeeding.
  -  Have difficulty in swallowing.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: UFUR (Tegafur/Uracil) Plus Iressa in Non-small-cell Lung Cancer

Summary: Iressa [epidermal growth factor tyrosine kinase inhibitor (EGFR-TKI)] has been reported to activity against Non-small-cell Lung Cancer (NSCLC) failed previous chemotherapy. UFUR was found to have anti-angiogenesis effect when long term treatment was given. Combination of EGFR-TKI and anti-angiogenesis agents is a novel treatment.

Detailed description: Iressa is a selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). It is an orally active agent for advanced non-small-cell lung cancer (NSCLC) in those who have failed a previous platinum-based regimen and taxane treatment. UFUR (Tegafur/Uracil) is effective agent against chemo-naïve NSCLC. It has anti-angiogenesis effect when used as long-term low dose treatment.
  Present phase II randomized clinical trial is designed to answer whether or not adding an oral anti-angiogenesis agent (UFUR), that has low toxicity profiles when long term use, to EGFR-TKI (Iressa) could increase patients survival and response rate.

Eligibility: Inclusion Criteria:
  -  Histologic or cytological diagnosis of NSCLC who failed previous platinum-based and taxanes chemotherapy.
  -  No prior radiotherapy on measurable lesion(s).
  -  Performance status of 0 to 3 on the Zubrod scale. (Reference 1)
  -  Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by CT scan, MRI, or chest x-ray.
  -  Informed consent from patient.
  -  Males or females 18 years of age or older.
  -  If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [IUD], birth control pills, or barrier device) during and for three months after trial.
  Exclusion Criteria:
  -  Active infection (at the discretion of the investigator).
  -  Inadequate liver function (total bilirubin >1.5 times above normal range); alanine transaminase (ALT) and aspartate transaminase (AST) greater than 5 times normal.
  -  Inadequate renal function (creatinine >2.0 mg/dL).
  -  Breast feeding.
  -  Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
  -  Concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or immunotherapy will not be allowed except as for palliative radiation to non-measurable lesion.

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Epidemiological Study to Evaluate the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

Summary: To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).


Eligibility: Inclusion Criteria:
  -  Signed written informed consent
  -  Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV)
  Exclusion Criteria:
  -  Mixed histology of small cell and non-small cell lung cancer

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

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: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications

Summary: The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications

Detailed description: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes

Eligibility: Inclusion Criteria:
  -  Patients with type 2 diabetes mellitus
  -  HbA1c ≥6.5%. (based on the last measured and documented laboratory measurement within 6 months)
  -  High risk for CV events -Established cardiovascular disease and/or multiple risk factors
  Exclusion Criteria:
  -  Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
  -  Acute vascular event <2months prior to randomisation

Relevance to patient case: not relevant