Non-Small Cell Lung Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 -Histologically or cytologically confirmed, treatment-naieve Stage IV non-squamous NSCLC -No prior treatment for Stage IV non-squamous NSCLC. -Measurable disease as defined by RECIST v1.1 -Adequate hematologic and end organ function
Exclusion criteria
Exclusion criteria: -Participants with a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or with an anaplastic lymphoma kinase (ALK) fusion oncogene -Active or untreated central nervous system (CNS) metastasis -Malignancies other than NSCLC within 5 years prior to randomization -Known tumor PD-L1 expression status from other clinical studies -History of certain autoimmune disease -History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis -History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds -Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies -Severe infection within 4 weeks prior to randomization -Significant history of cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy RECIST v1.1, Observation | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics safety RECIST v1.1, Observation | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America