Study Comparing Belrestotug and Dostarlimab with Placebo and Pembrolizumab in Untreated Patients with High PD-L1 Non-Small Cell Lung Cancer

Inclusion Criteria

• Diagnosed with advanced non-small cell lung cancer (NSCLC) that cannot be removed by surgery or treated with radiation.
• Have not received any previous treatment for advanced or metastatic NSCLC.
• Provide a new tumor sample taken at the time of or after the diagnosis of advanced NSCLC.
• Have a tumor with high levels of PD-L1 (at least 50% of tumor cells).
• Have at least one measurable tumor.
• Be in good overall health with a performance status score of 0 or 1.
• Have adequate organ function.

Exclusion Criteria

• Have NSCLC with specific genetic changes that can be treated with available targeted therapies.
• Have had surgery within 4 weeks before starting the study treatment and not fully recovered.
• Have received radiation therapy to the lungs of more than 30 gray (Gy) within the last 6 months.
• Have previously been treated with immune checkpoint inhibitors.
• Have never smoked more than 100 cigarettes in a lifetime.
• Have had another invasive cancer within the last 5 years, except for certain low-risk cancers.
• Have untreated or worsening brain metastases or cancer in the membranes covering the brain.
• Have an autoimmune disease that required treatment in the past 2 years.
• Have received a live vaccine within 30 days before starting the study treatment.
• Have a history of lung diseases like pulmonary fibrosis or pneumonitis.
• Have fluid buildup in the abdomen, around the lungs, or heart that causes symptoms.
• Have active inflammatory bowel disease.
• Have had significant heart problems in the last 6 months.
• Have a severe infection or complication within 4 weeks before starting the study.
• Have had a tissue or organ transplant.