MedTrace Logo

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)

NCT04165798 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1065

Last updated 2026-05-18

No results posted yet for this 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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DIAGNOSTIC_TEST

Tumor Imaging

Participants will undergo tumor imaging using either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.

PROCEDURE

Tumor Tissue Collection

Participants without archival tumor tissue samples will undergo tumor tissue collection for newly obtained tumor tissue.

PROCEDURE

Blood Sample Collection

Participants will have blood samples drawn for analysis of: * genetics * ribonucleic acid (RNA) * serum biomarker * plasma biomarker * circulating tumor DNA (ctDNA)

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2032-02-13
Completion
2032-02-13
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Israel
  • Italy
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04165798 on ClinicalTrials.gov