Clinical Trials

Inclusion Criteria:

Patients with histologically or cytologically documented squamous or non-squamous NSCLC who either have stage IIIb or stage IIIc disease who are not candidates for treatment with definitive concurrent chemo-radiation or have stage IV disease. Patients must have PD after receiving one prior line of chemotherapy treatment for advanced NSCLC. 

Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue biopsy sample.

Biopsy evaluable for expression of PD-L1 as determined by a PD-L1 Immunohistochemistry (IHC) pharma diagnostic test (pharmDx) assay performed by a central laboratory. 

At least 1 radiographically measureable lesion by computed tomography (CT) per RECIST 1.1 criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.

Exclusion Criteria:

• Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime.
• Active or untreated brain metastases or spinal cord compression.
• Patients with tumors tested positive for epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase (ROS1) fusions.
• Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization.
• History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years.
• Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest a risk of immunerelated treatment-emergent adverse events (irTEAEs).
• Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization.
  • Note: Other protocol defined Inclusion/Exclusion criteria apply.