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Study identifier: NCT04165070 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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)

Condition: Carcinoma, Non-Small-Cell Lung  ·  Sponsor: Merck Sharp & Dohme LLC

PhasePhase 1/Phase 2
Planned participants450
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Toll Free Number  ·  1-888-577-8839  ·  Trialsites@msd.com

Always discuss trial participation with your own doctor first.

Locations (46)

Banner MD Anderson Cancer Center ( Site 0001)Gilbert, Arizona, United StatesActive Not Recruiting
City of Hope ( Site 0014)Duarte, California, United StatesCompleted
UCSF Medical Center at Mission Bay ( Site 0007)San Francisco, California, United StatesCompleted
Georgetown University ( Site 0036)Washington D.C., District of Columbia, United StatesCompleted
University of Kentucky Markey Cancer Center ( Site 0019)Lexington, Kentucky, United StatesCompleted
MedStar Franklin Square Medical Center ( Site 0033)Baltimore, Maryland, United StatesCompleted
Massachusetts General Hospital ( Site 0003)Boston, Massachusetts, United StatesCompleted
Dana Farber Cancer Institute ( Site 0002)Boston, Massachusetts, United StatesCompleted
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)Omaha, Nebraska, United StatesCompleted
Dartmouth Hitchcock Medical Center ( Site 0016)Lebanon, New Hampshire, United StatesRecruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)Hackensack, New Jersey, United StatesCompleted
Laura and Isaac Perlmutter Cancer Center ( Site 0034)New York, New York, United StatesCompleted

+ 34 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04165070