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