Biomarkers Impact On the response to Treatment with Erlotinib in first line non-small cell lung Cancer with EGFR activating mutations

INTERVENTION: Trade Name: Tarceva Pharmaceutical Form: Capsule INN or Proposed INN: ERLOTINIB CAS Number: 183321‐74‐6 Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ CONDITION: Non‐small cell lung cancer PRIMARY OUTCOME: Main Objective: To evaluate progression free survival ; Primary end point(s): A sample of 30 patients with adenocarcinoma and EGFR activating mutations will enable an evaluation with a 5% type I error (providing a statistical significance with p = 0.05 and a confidence interval of 95%) of the association between the treatment efficacy (treatment response), including the PFS evaluation (progression‐free survival) and EGFR‐PCR activating mutations.; ; Starting from the incidence found in the inventoried trials on patients with EGFR activating mutations and adenocarcinoma ranging between 6% and 28% for Caucasian patients, we estimate that the PCR EGFR testing will be required in approximately 110 patients (at least) and 200 patients (probably more) with adenocarcinoma in order to find the 30 patients to be included in the trial. Patients will be tested until the established number of patients to be included in the study is reached.; Secondary Objective: To evaluate time till progression (TTP); To evaluate objective response rate; To evaluate 1‐year survival rate.; To determine the localization of disease progression.; To establish the profile of patient with EGFR activating mutations, evaluated based on sex, age, incidence of mutations, type of mutations, smoking status; To collect local epidemiological data such as the incidence of EGFR mutations for Romanian lung cancer patients; To establish percentage of associations between mutations detected from tumor sample and mutations detected from blood sample for all tested patients (if samples will be available at baseline and testing mutations from blood line will be possible); INCLUSION CRITERIA: 1. Written informed consent (informed consent document to be approved by the National Ethics Committee and consent obtained prior to any study‐specific procedure) for biomarkers testing and drug administration 2. Able to comply with the protocol 3. Age = 18 years 4. Histological documented adenocarcinoma, locally advanced ‐ stage IIIb, metastatic ‐ stage IV or recurrent non‐squamous NSCLC. 5. Eastern Cooperative Oncology Group PS status 0‐1 6. Life expectancy = 12 weeks 7. Patients must have evidence of disease with at least one measurable disease evaluate on RECIST criteria 8. Adequate haematological function: a. Absolute neutrophil count (ANC) =1.5 x 109/L AND b. Platelet count =100 x 109/L AND c. Haemoglobin =9 g/dL (may be transfused to maintain or exceed this level) 9. Adequate liver function: d. Total bilirubin <1.5 x upper limit of normal (ULN) AND e. Asparagine aminotransferase (AST), alanine aminotran