Study on the Effectiveness of Combining Fianlimab and Cemiplimab Compared to Cemiplimab Alone for Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

• Have advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation, or has spread to other parts of the body.
• Have not received any previous systemic treatment for recurrent or metastatic NSCLC.
• Provide a tumor tissue sample for testing.
• For phase 2, have a PD-L1 level of 50% or higher, as determined by a certified laboratory.
• For phase 3, have PD-L1 expression in 50% or more of tumor cells, confirmed by a central laboratory.
• Have at least one tumor that can be measured by a CT or MRI scan.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have adequate organ and bone marrow function.

Exclusion Criteria

• Have never smoked or smoked 100 or fewer cigarettes in a lifetime.
• Have untreated or active brain or spinal cord cancer spread. Patients with treated and stable brain metastases may be eligible.
• Have tumors with specific gene mutations or translocations, such as EGFR, ALK, or ROS1.
• Have had encephalitis, meningitis, or uncontrolled seizures in the past year.
• Have a history of certain lung diseases or pneumonitis that required treatment with steroids.
• Have known primary immunodeficiencies or significant autoimmune diseases requiring treatment in the past two years.
• Require corticosteroid therapy above 10 mg of prednisone per day within 14 days of starting the study.
• Have received certain prior systemic therapies, except for specific cases outlined in the study, such as certain chemotherapy or immunotherapy treatments completed over 6 to 12 months ago.