Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation

Inclusion Criteria:

   - Pathologically confirmed diagnosis of non-small cell lung cancer with EGFR mutation

   - Complete surgical resection, pathologic stage IA-B, IIA-B, IIIA-B by AJCC 7th Edition
   staging criteria

   - Surgical resection with curative intent was at least 6 months prior to enrollment

   - At least 3 weeks have passed since completion of adjuvant chemotherapy or radiotherapy

Exclusion Criteria:

   - Pregnant or breastfeeding

   - History of allergic reactions attributed to compounds of similar chemical composition
   to afatinib

   - Prior exposure to EGFR tyrosine kinase inhibitor

   - Evidence of clinically active interstitial lung disease

   - Radiographic evidence of recurrent NSCLC prior to afatinib treatment

   - Receipt of any experimental treatment within 30 days of start of treatment with
   afatinib until the end of treatment visit

   - Use of potent P-gp inhibitors and potent P-gp inducers must be avoided during
   treatment with afatinib

   - Individuals with a history of a different malignancy (except: synchronous or
   metachronous primary non-small cell lung cancers of lower stage than the cancer for
   which adjuvant treatment is currently being prescribed; disease free for at least 3
   years; cervical cancer in situ; basal or squamous cell carcinoma of the skin)

   - HIV positive on combination antiretroviral therapy

   - Uncontrolled intercurrent illness