Study Detail

CRITERIA

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

• A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC.
• Has not received prior systemic treatment for metastatic NSCLC.
• Has measurable disease based on RECIST 1.1, as determined by the local site assessment.
• Has a life expectancy of at least 3 months.
• Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method.

Exclusion Criteria:

• Known additional malignancy that is progressing or has required active treatment within

the past 3 years.

• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Severe hypersensitivity to vibostolimab, pembrolizumab, chemotherapy components, and/or any of its excipients.
• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
• Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or

has current pneumonitis/interstitial lung disease.

• Has an active infection requiring systemic therapy.
• Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus.
• Received prior systemic anticancer therapy for metastatic disease.
• Received a live or live attenuated vaccine within 30 days before the first dose of study

intervention. Administration of killed vaccines are allowed.

• History of allogeneic tissue/solid organ transplant.
• Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
• Is unable or unwilling to take folic acid or vitamin B12 supplementation.
• Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.