Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M

Inclusion Criteria: * Patient aged 18 years or older * Patients with histological confirmation of locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with an activating EGFR mutation and concomitant T790M mutation who are not candidates for local curative treatment. * Patients with a M1a stage according to the TNM version 7 including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease that is not a candidate for curative treatment (including patients who progress after chemoradiotherapy in stage III disease). * Patients with a EGFR deletion or mutation in exon 19, exon 21 (L858R, L861Q) or exon 18 (G719X) and concomitant T790M mutation before treatment confirmed centrally. * ECOG (Eastern Cooperative Oncology Group) performance status less than or equal to 2. * Existence of measurable or evaluable disease (as per RECIST 1.1 criteria). Patients with asymptomatic and stable brain metastases are eligible for the study. * Possibility of obtaining sufficient tissue sample, via a biopsy or surgical resection of the primary tumor or metastatic tumor tissue, within the 60 days prior to study entry. * Life expectancy ≥12 weeks. * Adequate hematologic function: * Absolute neutrophil count (ANC) \> 1.5 x 109/L * platelet count \> 100.0 x109/L * hemoglobin \> 9.0 g/dL (\> 6.2 mmol/L). * Adequate coagulation: INR ≤ 1.5. * Adequate liver function * Adequate renal function. * Capacity to swallow, patient capable of completing…