- Evidence of pathologically confirmed, advanced NSCLC (with known histology).
- Prior treatment with at least one and no more than two systemic therapy regimens (at
least one must be standard chemotherapy for advanced NSCLC).
- Adequate tissue sample must be submitted prior to randomization for tumor biomarker
- Adequate renal, hematologic, liver function.
- ECOG PS of 0-2.
- Radiologically measurable disease.
- Small cell histology.
- Symptomatic brain mets or known leptomeningeal mets.
- Prior therapy with agent known or proposed to be active by action on EGFR tyrosine
kinase or other HER family proteins.
- Uncontrolled medical disorders.