Pennell NA, et al. - In this open-label phase 2 trial of erlotinib as an adjuvant for epidermal growth factor receptor (EGFR)-mutant early-stage non–small-cell lung cancer (NSCLC), 2-year disease-free survival (DFS) was assessed following treatment with erlotinib 150 mg per day for 2 years after standard adjuvant chemotherapy with or without radiotherapy in patients with resected stage IA to IIIA EGFR-mutant NSCLC. A total of 100 patients at 7 sites were enrolled, with different stages of disease. With a median follow-up of 5.2 years, 2-year DFS was 88% (96% stage I, 78% stage II, 91% stage III) and 5-year DFS was 56% (95% CI, 45% to 66%), 5-year overall survival was 86% (95% CI, 77% to 92%). Median DFS and overall survival were not reached. Besides typical erlotinib toxicities, no grade 4 or 5 adverse events were seen. An improved 2-year DFS was observed in patients with EGFR-mutant NSCLC treated with adjuvant erlotinib vs historic genotype-matched controls. Adjuvant erlotinib was associated with rare recurrences, and durable benefit was seen in patients rechallenged with erlotinib following recurrence.