- Histologically or cytologically proved diagnosis of locally advanced recurrent or
metastatic non-squamous NSCLC that is not suitable for local curative treatment.
- Alk-positive NSCLC as determined by a test that is approved or validated for use as a
companion diagnostic test.
- No prior systemic therapy for metastatic disease.
- Adjuvant chemotherapy more than 12 months prior to study enrollment.
- Measurable disease as per RECIST 1.1
- ECOG PS 0 or 1.
- Prior exposure to ALK receptor tyrosine kinase inhibitor, anti-PD1, anti-PDL1 or any
drug targeting T-cell checkpoint pathways.
- known diagnosis of immunodeficiency or is receiving systemic steroid therapy or other
form of immunosuppressive therapy within 7 days of clinical trial treatment.
- Active autoimmune disease that has required systemic treatment in the past 3 months.
- History of extensive disseminated interstitial fibrosis or any grade of interstitial