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NCT04165798 · ClinicalTrials.gov registry record

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)

A clinical trial of Carcinoma, Non-Small Cell Lung, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
1,065
Enrollment target
20
Study locations

NCT04165798: Recruiting study of Carcinoma, Non-Small Cell Lung, sponsored by Merck Sharp & Dohme.

NCT04165798 is a study of Carcinoma, Non-Small Cell Lung that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,065 participants, above the 316-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (237% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04165798, a study of Carcinoma, Non-Small Cell Lung, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
1,065 participants
Enrollment target
20
Study locations

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.

Primary Outcome

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.

Conditions Studied

Carcinoma, Non-Small Cell Lung

Interventions

  • DIAGNOSTIC_TEST Tumor Imaging
  • PROCEDURE Tumor Tissue Collection
  • PROCEDURE Blood Sample Collection

Study Locations (20)

California

  • City of Hope ( Site 0014) - Duarte
  • UCSF Medical Center at Mission Bay ( Site 0007) - San Francisco

Massachusetts

  • Massachusetts General Hospital ( Site 0003) - Boston
  • Dana Farber Cancer Institute ( Site 0002) - Boston

Ohio

  • Cleveland Clinic Main ( Site 0006) - Cleveland
  • Ohio State University Comprehensive Cancer Center ( Site 0015) - Columbus

Arizona

  • Banner MD Anderson Cancer Center ( Site 0001) - Gilbert

District of Columbia

  • Georgetown University ( Site 0036) - Washington D.C.

Kentucky

  • University of Kentucky Markey Cancer Center ( Site 0019) - Lexington

Maryland

  • MedStar Franklin Square Medical Center ( Site 0033) - Baltimore

Nebraska

  • Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) - Omaha

Trial Details

FieldValue
Enrollment Target 1,065 participants
Start Date 2019-12-19
Est. Completion 2032-02-13
Merck Sharp & Dohme

558 total trials

What NCT04165798 shows while recruiting

NCT04165798 is an observational study that tracks outcomes without assigning an intervention. Its 1,065 participants enrollment target places it among the larger protocols in the corpus, above the 316-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (237% higher).

The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 3 interventions - of which Tumor Imaging is the first listed.

NCT04165798 names 20 study sites across 17 states, led by California, Massachusetts, Ohio.

Frequently Asked Questions

What is clinical trial NCT04165798 about?

NCT04165798 is a clinical study titled "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 substud...

What is the current status of trial NCT04165798?

This trial is currently recruiting. The enrollment target is 1,065 participants. The study started on 2019-12-19. Estimated completion is 2032-02-13.

What conditions does trial NCT04165798 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.

What interventions are being tested in trial NCT04165798?

The interventions under investigation include: Tumor Imaging (DIAGNOSTIC_TEST), Tumor Tissue Collection (PROCEDURE), Blood Sample Collection (PROCEDURE).

Who is sponsoring clinical trial NCT04165798?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04165798 being conducted?

This trial has 20 study locations across Arizona, California, District of Columbia, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Carcinoma, Non-Small Cell Lung

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04165798's enrollment target sits among peer trials

1,065 5th of 130 higher than 126 of 130 other Carcinoma, Non-Small Cell Lung trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04165798

Source: ClinicalTrials.gov NCT04165798, the US trial registry maintained by the National Library of Medicine. NCT04165798 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.