KEYMAKER-U01 Substudy 2: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab in Treatment Naïve Patients With PD-L1 Positive Advanced Non-small Cell Lung Cancer (NSCLC)
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with MK-4830 in treatment-naïve participants with advanced squamous or non-squamous NSCLC that is PD-L1 positive. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01). The pembrolizumab+ MK-0482 arm was added with Amendment 6.
• Has a histologically- or cytologically-confirmed diagnosis of Stage IV squamous or non-squamous NSCLC
• Has non-squamous NSCLC and is not eligible for an approved targeted therapy
• Is able to provide archival tumor tissue sample collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initiation
• Has not received prior systemic treatment for metastatic NSCLC
• Has programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%
• Is able to complete all screening procedures within the 35-day screening window.
• Male participants must agree to use contraception and refrain from donating sperm during the treatment period and for at least 120 days after the last dose of study treatment
• Female participants must not be pregnant or breastfeeding, and at least one of the following conditions apply:
‣ Not a woman of childbearing potential (WOCBP) OR
⁃ A WOCBP who agrees to use contraception during the treatment period and for at least 120 days after the last dose of study treatment
• Has adequate organ function within 10 days of initiation of study treatment