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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)
KEYMAKER-U01 Master Study: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants With Non-small Cell Lung Cancer (NSCLC)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the 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.
What is being tested
- Tumor Imaging (diagnostic test)
- Tumor Tissue Collection (procedure)
- Blood Sample Collection (procedure)
Sponsor: Merck Sharp & Dohme LLC · Participants: 1,065 · Started: Dec 19, 2019
Contact the study team
- Toll Free Number · Phone: 1-888-577-8839
Official record on ClinicalTrials.gov — NCT04165798
Locations in the U.S.
| New Hampshire | Dartmouth Hitchcock Medical Center ( Site 0016), Lebanon |
| North Dakota | Sanford Fargo Medical Center ( Site 0039), Fargo |
| Ohio | Ohio State University Comprehensive Cancer Center ( Site 0015), Columbus |
| Pennsylvania | Abramson Cancer Center of the University of Pennsylvania ( Site 0010), Philadelphia |
| South Dakota | Sanford Cancer Center ( Site 0038), Sioux Falls |
| Texas | The University of Texas MD Anderson Cancer Center ( Site 0009), Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.