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NCT04165798RECRUITING

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)

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 / Drugs
Tumor ImagingTumor Tissue CollectionBlood Sample Collection
View on ClinicalTrials.gov ↗
Sponsor
MRK
Merck & Co
Oncology/Vaccines
F35/100
Study Details
Enrollment1065 participants
Primary Completion—
Lead SponsorMerck Sharp & Dohme LLC
Data Retrieved2026-04-11 02:55:36.206287+00:00
What This Trial Means for Biotech Investors
Trial Phase Context
Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 1,065 participants
Sponsor Catalyst Profile

Merck & Co (MRK) is the sponsoring company for this trial. BiotechSign currently grades this company F (35/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

MRK Full Pipeline →All Companies →
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