Abbreviations
ATEZ
chemo
277
277
Phase:
3
Open label
NSCLC
na, Nonsquamous, Squamous
meta
L1
- Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC - No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study - Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 - Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) - Adequate hematologic and end-organ function.
- Known sensitizing mutation in the EGFR gene or ALK fusion oncogene - Active or untreated central nervous system (CNS) metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation - Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome - Pregnant or lactating women - History of autoimmune disease - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. - History of radiation pneumonitis in the radiation field (fibrosis) is permitted - Positive test for Human Immunodeficiency Virus (HIV) - Active hepatitis B or hepatitis C - Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody - Severe infection within 4 weeks prior to randomization - Significant history of cardiovascular disease.