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KEYMAKER-U01 Umbrella Master Study for Non-small Cell Lung Cancer

This study, called KEYMAKER-U01, is looking at different ways to treat advanced non-small cell lung cancer (NSCLC). It's a large "umbrella" study that includes several smaller studies, each testing different investigational agents, either alone with pembrolizumab (MK-3475) or with pembrolizumab plus chemotherapy. You might be able to join if you have Stage IV squamous or non-squamous NSCLC that can be measured. The study aims to understand the levels of a protein called PD-L1 in tumors and the type of NSCLC you have. The current recruitment status is unclear, and the study plans to enroll about 1065 participants.

Study design
This is an observational study with a platform design, meaning it's a master screening study for several substudies. It plans to enroll about 1065 participants.
What's involved
You would undergo tumor imaging (MRI or CT scan), tumor tissue collection if you don't have recent samples, and blood sample collection for genetic and biomarker analysis.
Compensation
Not stated in the trial record.
Follow-up
Your PD-L1 tumor expression and tumor histology status will be measured for up to approximately 1 month.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04165798

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)

Recruiting
Not specifiedAges 18+Observational
Merck Sharp & Dohme LLC
~1,065 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Tumor ImagingTumor Tissue CollectionBlood Sample Collection

At a glance

Recruiting sites
20 of 47 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1%
Measured over Up to approximately 1 month
+1 more outcome measured

Conditions

Carcinoma, Non-Small-Cell Lung

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

47 sites across 33 states
Israel7
Taiwan3
California2
Massachusetts2
Ohio2
Italy2
South Korea2
Spain2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1%Up to approximately 1 month

    Participants' tumors will be evaluated for their PD-L1 tumor expression level using archival tumor tissue samples or newly obtained tumor tissue. The percentage of participants who have a Tumor Proportion Score (TPS) \<1% vs. a TPS =1% will be presented.

  • Tumor Histology Status: Squamous Non-small Cell Lung Cancer (NSCLC) vs. Nonsquamous NSCLCUp to approximately 1 month

    Participants' tumors will be evaluated for their tumor histology status as being either squamous vs. nonsquamous NSCLC using archival or newly obtained tumor tissue samples. The percentage of participants who have squamous vs. nonsquamous NSCLC will be presented.