SELECT: A multicenter phase II trial of adjuvant erlotinib in resected early-stage EGFR mutation-positive NSCLC.

7514 Background: EGFR mutant NSCLC is exquisitely sensitive to EGFR tyrosine kinase inhibitors (TKIs). Retrospective data suggests adjuvant TKIs may improve outcomes. This trial is the first to prospectively test the efficacy of adjuvant erlotinib in EGFR-mutant NSCLC. Methods: Eligible pts had resected stage IA-IIIA NSCLC harboring a TKI-sensitizing EGFR mutation. Pts were treated with erlotinib 150 mg/day for 2 years after completion of standard adjuvant chemotherapy and/or radiotherapy. With a sample size of 100 pts the study was powered to demonstrate a primary endpoint of 2-year disease free survival (DFS) u003e85%, compared to a historical control of 76% in resected early-stage EGFR-mutant NSCLC. Results: 100 pts were enrolled at 7 sites between 1/08 and 5/12; 45% stage I; 27% stage II; 28% stage IIIA. 89 pts have reached 2 year follow-up (2 year follow-up on the entire cohort will be presented at the annual meeting). Toxicities were typical of erlotinib with no G4/5 events and 1 G2 pulmonary fibrosis. ...