Study Comparing Subcutaneous and Intravenous Pembrolizumab with Chemotherapy for Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

• Diagnosed with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC).
• Cancer is at Stage IV, meaning it has spread to other parts of the body.
• No need for specific targeted therapies for certain genetic mutations in nonsquamous NSCLC.
• Have not received previous treatment for metastatic NSCLC, except if prior treatment was completed over a year ago.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Male participants must agree to use contraception unless confirmed to be unable to father children.
• Female participants must not be pregnant or breastfeeding and must agree to use contraception if of childbearing potential.
• Have measurable cancer as determined by standard criteria.
• Provide a tumor sample for testing before starting the study.
• Have adequate organ function as shown by specific medical tests.

Exclusion Criteria

• Have another active cancer that is progressing or required treatment in the past 3 years.
• Have untreated or active cancer spread to the brain or spinal cord, unless stable after treatment.
• Have severe allergies to the study drug or its ingredients.
• Have an active autoimmune disease needing treatment in the past 2 years.
• Have a history of lung disease requiring steroids or current lung disease.
• Have an active infection needing treatment.
• Have a history of HIV, Hepatitis B, or active Hepatitis C.
• Have a psychiatric or substance abuse disorder affecting study participation.
• Have fluid buildup in the abdomen or around the lungs unless stable after treatment.
• Have received certain cancer treatments or major surgery recently.
• Have had recent radiation therapy to the lungs or other areas.
• Need other cancer treatments during the study.
• For nonsquamous NSCLC, cannot stop certain medications or take required supplements.
• Have had a recent live vaccine.
• Are in another clinical trial or using an investigational device.
• Have an immune deficiency or are on immunosuppressive therapy.
• Have had a tissue or organ transplant.