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Investigating Pembrolizumab Alone or With Chemotherapy for Non-Small Cell Lung Cancer

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)

Observational Merck Sharp & Dohme LLC · NCT04165798

This study is testing whether the drug pembrolizumab, alone or with chemotherapy, can help people with non-small cell lung cancer.

Quick facts

Study typeObservational
Enrollment1065 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionspembrolizumab, chemotherapy
Locations47 sites (Gilbert, Arizona and 46 other locations)
Trial IDNCT04165798 on ClinicalTrials.gov

What this trial studies

This umbrella master protocol study aims to screen participants with non-small cell lung cancer (NSCLC) for enrollment into one of seven substudies evaluating the efficacy of pembrolizumab, both alone and in combination with chemotherapy or other investigational agents. Participants will first enroll in the master protocol and undergo screening to determine their eligibility for specific substudies based on their cancer characteristics and treatment history. The study utilizes a platform design to facilitate the evaluation of multiple treatment combinations in a structured manner.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically-confirmed Stage IV squamous or nonsquamous NSCLC who have not received prior systemic treatment.

Not a fit: Patients with preexisting moderate neuropathy or those who have received prior systemic treatment for metastatic NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for patients with advanced non-small cell lung cancer.

How similar studies have performed: Other studies using similar umbrella protocols have shown promise in evaluating combination therapies for various cancers, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Gilbert, Arizona and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Non-Small-Cell LungProgrammed Cell Death-1Programmed Death-Ligand 1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.