Study on the Safety and Effectiveness of Zimberelimab, Domvanalimab, and Etrumadenant for Previously Treated Non-Small Cell Lung Cancer

Inclusion Criteria

• Have a confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC), either squamous or non-squamous type.
• Have been treated with at least one, but no more than two, previous therapies for metastatic cancer, including immune checkpoint therapy.
• Have a PD-L1 expression level of at least 1% as determined by a specific test.
• Have at least one tumor that can be measured by standard criteria.
• Be at least 18 years old.
• Have a performance status that allows for normal daily activities or some restrictions.
• Have normal blood and organ function, including:
  • Neutrophil count of at least 1,500/µL
  • Platelet count of at least 100,000/µL
  • Hemoglobin level of at least 9.0 g/dL
  • Bilirubin level within specified limits, with exceptions for Gilbert's syndrome
  • Liver enzymes within specified limits
  • Kidney function within specified limits
• If you have brain or meningeal metastases, they must be stable and not require immediate treatment.
• Agree to use effective birth control during the study and for 100 days after the last dose.
• Be able to understand and sign a consent form.

Exclusion Criteria

• Have a history of another type of cancer, unless it was treated and there is no evidence of disease for at least 2 years.
• Have specific genetic mutations (EGFR, ALK, ROS1, RET) that are treatable with other therapies.
• Be currently receiving or have recently received other investigational drugs.
• Have allergies to the study drugs or similar compounds.
• Have received a live vaccine within 28 days of starting the study.
• Have gastrointestinal issues that prevent taking oral medications.
• Have had major surgery or trauma within 28 days before starting the study.
• Have medical conditions that make the study treatment unsafe, such as lung disease or active infections.
• Require high doses of steroids or other immunosuppressive drugs.
• Test positive for hepatitis B, hepatitis C, or HIV.
• Have mental health or substance abuse issues that interfere with the study.
• Have active autoimmune diseases requiring treatment in the past 2 years, except for certain conditions like vitiligo.
• Be pregnant or breastfeeding.
• Have taken certain medications that interact with Etrumadenant within 4 weeks before starting the study.