- Diagnosis of advanced or metastatic NSCLC. Group A must be ALK negative NSCLC and
Group B must be ALK positive NSCLC
- Group A at least one prior regimen of therapy
- Group B any number of prior regimens.
- Mandatory tumor tissue available
- At least one measurable lesion
- ECOG Performance status 0 or 1
- Adequate bone marrow, renal, liver and pancreatic function
- Negative pregnancy test for females of childbearing potential
- Group B Phase 2: No prior systemic treatment for advanced or metastatic disease
(adjuvant and/or neoadjuvant therapies are allowed if completed at least 6 months
prior to study entry. No prior tyrosine kinase inhibitor therapy is allowed at any
time prior to study entry)
- No prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4
antibody.
- No Severe or Chronic medical conditions including gastrointestinal abnormalities or
significant cardiac history
- No active infection requiring systemic therapy
- Prior organ transplantation including allogenic stem cell transplantation.