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)
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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 8 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 25, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Merck Sharp & Dohme LLC
- Interventions being studied
- 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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- The main inclusion criteria include but are not limited to the following:
- Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC
- Participants with nonsquamous NSCLC who are 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 their metastatic NSCLC
- Is able to complete all screening procedures within the 35-day screening window for Part A and 28-day screening window for Part B
The main
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- 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
- MedStar Franklin Square Medical Center ( Site 0033)Baltimore, Maryland
- Massachusetts General Hospital ( Site 0003)Boston, Massachusetts
- Dana Farber Cancer Institute ( Site 0002)Boston, Massachusetts
- Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)Omaha, Nebraska
- Dartmouth Hitchcock Medical Center ( Site 0016)Lebanon, New Hampshire
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)Hackensack, New Jersey
- Laura and Isaac Perlmutter Cancer Center ( Site 0034)New York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 25, 2026. Always confirm current availability with the study team.