A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Histologically or cytologically confirmed Stage IIIB-IVB NSCLC
• For participants who have received prior neo-adjuvant/adjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease: a treatment-free interval of at least 6 months prior to enrollment
• Participants with any programmed death-ligand 1 (PD-L1) test result by immunohistochemistry (IHC) are eligible for the study
• Participants without a PD-L1 test result are eligible for the study
• Measurable disease per RECIST v1.1
• Adequate hematologic and end-organ function
• Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods among women of childbearing potential

Exclusion Criteria

• Prior treatment with immunotherapy for any stage NSCLC, including early-stage (neoadjuvant or adjuvant) disease
• Participants with epidermal growth factor receptor (EGFR) sensitizing mutations and anaplastic lymphoma kinase (ALK) rearrangements
• Active central nervous system (CNS) metastases requiring treatment
• Spinal cord compression not definitively treated or not clinically stable
• Leptomeningeal disease
• Uncontrolled tumor-related pain
• Uncontrolled pleural, pericardial effusions, or ascites requiring recurrent drainage procedures
• Uncontrolled or symptomatic hypercalcemia
• Malignancies other than NSCLC within 5 years prior to enrollment, except for those curatively treated with negligible risk of metastasis or death
• Pregnant or lactating women
• History of autoimmune disease, significant pulmonary disease, or significant cardiovascular disease
• Positive human immunodeficiency virus (HIV) or hepatitis B or C
• Active tuberculosis
• Severe infection or major surgery within 4 weeks, or oral or IV antibiotics treatment within 2 weeks prior to enrollment
• Prior treatment with or hypersensitivity to study drug or related compounds
• Prior allogeneic bone marrow or solid organ transplant
• Administration of a live, attenuated vaccine within 4 weeks prior to enrollment
• Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to enrollment
• Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to enrollment