Clinical Research Directory

Key Inclusion Criteria: * Written informed consent * Male or female, aged ≥18 years and ≤75 years * Histologically or cytologically documented lung adenocarcinoma with completely resectable disease (Stage II-IIIB N2, according to the 8th edition of the IASLC Staging Manual in Thoracic Oncology) * Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by an MDT evaluation * A tumor which harbors either Ex19del or L858R EGFR-TKI-sensitizing mutations, either alone * ECOG PS 0/1 at enrollment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing * Adequate organ and marrow function as defined by: * Hemoglobin: ≥9.0 g/dL * Absolute neutrophil count: ≥1.5 × 109/l * Platelet count: ≥100 × 109/l * Serum bilirubin: ≤1.5 ULN * ALT and AST: ≤2.5 × ULN * Creatinine clearance: ≥60 ml/min * Life expectancy of 6 months prior to randomization Exclusion Criteria: * Prior treatment with systemic anti-cancer treatment for NSCLC, EGFR-TKI treatment or pre-operative radiotherapy * EGFR-TKI-sensitizing mutations with T790M * Mixed small cell and non-small-cell lung cancer histology * T4 tumors infiltrating the aorta, esophagus and/or heart * Bulky N2 disease * Candidates for segmentectomies or wedge resections only * Medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment or any evidence of clinically active ILD * Severe or uncontrolled systemic diseases/active infections, history of allogeneic organ transplantation, history of primary immunodeficiency, history of another primary malignancy