Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR

Inclusion Criteria: * Pathologically confirmed diagnosis of NSCLC of adenocarcinoma histology * Stage IA-B, IIA-B, or IIIA by the American Joint Committee on Cancer 7th edition staging criteria * Patients must have undergone surgical resection with curative intent within 6 months of enrollment * Sufficient tumor tissue available for EGFR mutation analysis * At least ONE of the following patient characteristics: previously detected deletion 19 or L858R EGFR mutation, female sex, history of never smoking, or Asian/Pacific Rim ethnicity (to be enrolled in the screening portion of trial). * 18 years of age or older * Tumor samples must have either exon 19 deletion mutations or the exon 21 L858R point mutation * ECOG Performance status of 0,1, or 2 * Adequate organ function as outlined in protocol Exclusion Criteria: * Radiographic evidence of recurrent NSCLC prior to erlotinib treatment * Confirmed T790M resistance mutation in the primary tumor sample * Prior exposure to EGFR tyrosine kinase inhibitors * Known hypersensitivity to erlotinib, gefitinib, or any closely related drug * Pregnant or breastfeeding women * Any evidence of clinically active interstitial lung disease * Current use of enzyme-inducing anti-epileptic drugs, including carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, and primidone * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study * Use of any non-FDA approved or investigational agent within 2 weeks of enrolling onto the trial, or failure to recover from the side effects of any of these agents