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RecruitingCarcinoma, Non-Small-Cell Lung

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)

Eligible age

18+ yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

No

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About this study

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.

Sponsor: Merck Sharp & Dohme LLC

You may qualify if…

  • 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

You may not qualify if…

  • 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

Where it's recruiting

Arizona

Gilbert

California

Duarte · San Francisco

District of Columbia

Washington D.C.

Kentucky

Lexington

Maryland

Baltimore

New Jersey

Hackensack

New York

New York

Ohio

Cleveland · Columbus

Source: ClinicalTrials.gov · NCT04165798 · last updated 2026-06-23