A Phase 1b/2 Study in Asian Subjects With Non-Small Cell Lung Cancer

Exclusion Criteria

• •Phase 2 only: Prior chemotherapy or prior treatment with epidermal growth factor receptor (EGFR) inhibitor, including both tyrosine kinase inhibitors and monoclonal antibodies. There is no limit to the number of therapies for subject being considered for Phase 1b.
• •History of neoplasm other than the entry diagnosis.
• •Pregnancy or lactation.
• •Myocardial infarction within 6 months prior to initiation of study treatment.
• •A serious active infection.
• •Known human immunodeficiency virus infection.
• •A serious underlying medical condition that would impair the ability of the subject to receive protocol treatment.
• •A major surgical procedure, open biopsy, or significant traumatic injury.
• •Thrombotic or embolic events.
• •Known or suspected allergy/hypersensitivity to any agent given in the course of this trial.
• •Any condition that impairs absorption of oral agents or the subject's ability to swallow whole pills.
• •Diarrhea ≥ Grade 2 or active Inflammatory Bowel Disease.
• •Severe acute or chronic medical, psychiatric, or behavioral condition or laboratory abnormality.
• •Diagnosis of interstitial lung disease.
• •Any medications or treatments prohibited by the protocol.