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About
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.
Full description
The master screening protocol is MK-3475-U01(KEYMAKER-U01) - NCT04165798
Enrollment
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Inclusion and exclusion criteria
Inclusion:
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:
Has adequate organ function within 10 days of initiation of study treatment
Exclusion Criteria:
Primary purpose
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120 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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