DISCERN: Comparing Two Immune Therapy Combinations for PD-L1 Negative Non-Small Cell Lung Cancer

Inclusion Criteria

• Must provide signed consent to participate.
• Willing to follow all study procedures and available for the study duration.
• Aged 18 years or older.
• Diagnosed with stage IV non-small cell lung cancer (NSCLC).
• No known mutations for which there is an FDA-approved targeted therapy for NSCLC.
• No prior systemic treatment for advanced or metastatic disease, except possibly one cycle of chemotherapy while waiting for test results.
• Must have measurable disease based on specific criteria.
• Expected to live at least 3 more months.
• Performance status score of 0, 1, or 2, indicating varying levels of activity.
• Must provide tumor tissue samples showing PD-L1 status less than 1% or negative.
• Must have detectable circulating tumor DNA at the start of the study.
• If there are brain metastases, they must be treated and stable for at least 2 weeks.
• Must have adequate organ function to safely receive standard treatments.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for a specified time after.
• Men must agree to use condoms or other contraception methods during the study and for a specified time after.

Exclusion Criteria

• Currently in another study or received investigational treatment within the last 4 weeks.
• Received a live-virus vaccine within 30 days of starting treatment.
• Have active diverticulitis, abdominal abscess, or GI obstruction.
• History of allergy to specific immune therapy drugs.
• Known sensitivity to chemotherapy components like cisplatin or carboplatin.
• Have carcinomatous meningitis.
• Have active or suspected autoimmune diseases, with some exceptions.
• Used systemic corticosteroids or immunosuppressive drugs within 14 days before the study, with some exceptions.
• History or suspicion of lung diseases like ILD or pneumonitis.
• Positive for HIV, Hep B, or Hep C unless well-controlled.
• History of other cancers, except for certain skin cancers or in situ cancers treated curatively and in remission for over two years.