OncoMatch/Clinical Trials/NCT04165070
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)
Is NCT04165070 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for carcinoma, non-small-cell lung.
Treatment: Pembrolizumab · Carboplatin · Paclitaxel · Pemetrexed · Vibostolimab · Boserolimab · MK-4830 · MK-0482 · Ifinatamab Deruxtecan (I-DXd) · HER3-DXd — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage IV
Metastatic disease required
Prior therapy
Cannot have received: systemic cytotoxic chemotherapy
Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease
Cannot have received: targeted therapy
Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease
Cannot have received: biological antineoplastic therapy
Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease
Lab requirements
Cardiac function
clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment administration, or New York Heart Association Class III or IV congestive heart failure
Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment administration, or New York Heart Association Class III or IV congestive heart failure
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner MD Anderson Cancer Center ( Site 0001) · Gilbert, Arizona
- City of Hope ( Site 0014) · Duarte, California
- UCSF Medical Center at Mission Bay ( Site 0007) · San Francisco, California
- Georgetown University ( Site 0036) · Washington D.C., District of Columbia
- University of Kentucky Markey Cancer Center ( Site 0019) · Lexington, Kentucky
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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