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Life sciences · Phase 1/2 Trial

KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)

ClinicalTrials.gov · October 29, 2026

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What was studied

Phase 1/2 Trial.

Key findings

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Source abstract

Registry record from ClinicalTrials.gov (NCT04165070). This is a study registration, not published results. Lead sponsor: Merck Sharp & Dohme LLC. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 450 participants (ESTIMATED). Conditions: Carcinoma, Non-Small-Cell Lung. Interventions: BIOLOGICAL: Pembrolizumab; DRUG: Carboplatin; DRUG: Paclitaxel; DRUG: Pemetrexed; BIOLOGICAL: Vibostolimab; BIOLOGICAL: Boserolimab; BIOLOGICAL: MK-4830; BIOLOGICAL: MK-0482; BIOLOGICAL: Ifinatamab Deruxtecan (I-DXd); BIOLOGICAL: HER3-DXd. Primary outcome measures: Part A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) , Up to approximately 24 months; Part B: Number of Participants Who Experience One or More Adverse Events (AEs) , Up to approximately 27 months; Part B: Number of Participants Who Discontinue Study Intervention Due to an Adverse Event (AE) , Up to approximately 24 months; Part B: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) , Up to approximately 3 Weeks. Brief summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

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