Study on Intismeran Autogene (V940) or Placebo with Pembrolizumab and Chemotherapy for Metastatic Squamous Non-Small Cell Lung Cancer

Inclusion Criteria

• Diagnosed with advanced squamous non-small cell lung cancer (NSCLC) that has spread (Stage IV).
• Have measurable cancer that can be tracked using standard criteria.
• Provided a tissue sample from a site not previously treated with radiation.
• Any side effects from previous cancer treatments must have improved to a mild level.
• If HIV-positive, must have well-controlled HIV with medication.
• If positive for hepatitis B, must have been treated and have an undetectable viral load.
• If previously infected with hepatitis C, must have an undetectable viral load after treatment.
• Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have a life expectancy of at least 3 months.
• Have adequate organ function as determined by specific medical tests.

Exclusion Criteria

• HIV-positive with a history of certain cancers like Kaposi's sarcoma.
• Previously treated with a cancer vaccine or similar therapies.
• Received prior treatment for metastatic NSCLC.
• Previously treated with certain immune therapies unless it was completed over a year ago for non-metastatic NSCLC.
• Received recent radiation therapy or have radiation-related side effects.
• Received a live vaccine within 30 days before starting the study.
• Participated in another clinical trial or used an investigational device recently.
• Have an immune deficiency or are on high-dose steroids or other immune-suppressing treatments.
• Have another active cancer that required treatment in the past 3 years.
• Have active cancer spread to the brain or spinal cord.
• Have severe allergies to study drugs or their components.
• Have an active autoimmune disease needing treatment in the past 2 years.
• Have a history of lung inflammation requiring steroids.
• Have an active infection needing treatment.
• Have had a stem cell or organ transplant.
• Have not fully recovered from major surgery.