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RecruitingNot applicableNCT04165798
Official study title

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)

Study summary

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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedTumor Imaging and Tumor Tissue Collection

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 25, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Observational

Where is it offered?47 U.S. locations

Locations may change over time.

Who runs it?Merck Sharp & Dohme LLC

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

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.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion criteria

The main

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

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.

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