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