KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.
Checked against the public recordLast updated Aug 25, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Merck Sharp & Dohme LLC
- Interventions being studied
- Diagnostic Test: Tumor Imaging; Procedure: Tumor Tissue Collection; Procedure: Blood Sample Collection
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 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 * Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has an active infection requiring systemic therapy
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 at NYU Langone Health ( 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.