- Histologic confirmation of metastatic non-small cell lung cancer (NSCLC) and confirmed ALK rearrangement.
- Measurable disease according to RECIST 1.1.
- Availability of archival (diagnostic) specimens and willing to undergo a pre-treatment biopsy.
- Subjects with treated brain metastases must have been treated with surgery and/or radiation therapy ≥ 21 days pre-study and must be clinically stable.
- Laboratory parameters for vital functions should be in the normal range or not clinically significant.
- Body weight > 30 kilograms.
- Treatment with an investigational agent within 4 weeks of starting treatment.
- Prior treatment with anti-PD-1, PD-L1, or CTLA4, or ensartinib (X-396).
- Active, suspected or prior documented autoimmune disease.
- Subjects with clinically significant cardiovascular disease.
- History of pneumonitis or interstitial lung disease, or any unresolved immune-related adverse events.
- Major surgery within 4 weeks of starting treatment.
- Active infection including tuberculosis, hepatitis B or C, or human immunodeficiency virus.
- History of allogenic organ transplant.
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|