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Background: Adjuvant chemotherapy for patients (pts) with resected NSCLC provides a modest survival benefit, but a large proportion of pts still relapse, presumably due to inherent chemoresistance. Tumors with activating EGFR mutations are exquisitely sensitive to the EGFR tyrosine kinase inhibitors (TKIs) gefitinib and erlotinib; hence the use of adjuvant TKIs may more effectively prevent recurrences. This trial investigates the safety and efficacy of adjuvant erlotinib in pts with stage I-IIIA NSCLC and somatic EGFR mutations.

Methods: Eligible pts have surgically resected stage IA-IIIA NSCLC and activating EGFR mutations. Within 6 months of surgery, and following the completion of routine adjuvant treatment, pts are treated with 150 mg/day of erlotinib for a total of 2 years, with surveillance scans every 6 months. The primary endpoint is disease-free survival at 2 years.

Results: Thirty-six …