Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma

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