Recruiting

Pembrolizumab & ChemotherapyKEYMAKER-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)

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT04165798

Conditions

Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tumor Imaging

Tumor Tissue Collection

Blood Sample Collection

Study Details

Brief 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

Study ID

NCT04165798

Start date

Dec 19, 2019

Status verified date

Aug, 2026

Completion date

Feb 13, 2032

Anticipated

Primary completion date

Feb 13, 2032

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1065 participants

Anticipated

Interventions and Outcome Measures

Arms

Prospective NSCLC Participants

Male and female participants with histologically-confirmed diagnosis of squamous or nonsquamous NSCLC will be screened for participation in 1 of several pembrolizumab substudies.

Interventions

Tumor Imaging

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

Tumor Tissue Collection

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

Blood Sample Collection

Participants will have blood samples drawn for analysis of:

genetics
ribonucleic acid (RNA)
serum biomarker
plasma biomarker
circulating tumor DNA (ctDNA)

Primary outcome measure

Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1% [ Time Frame: Up to approximately 1 month ]
Tumor Histology Status: Squamous Non-small Cell Lung Cancer (NSCLC) vs. Nonsquamous NSCLC [ Time Frame: Up to approximately 1 month ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Dartmouth Hitchcock Medical Center ( Site 0016)

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

Study Coordinator

603-650-4428

Sanford Fargo Medical Center ( Site 0039)

Recruiting

Fargo, North Dakota, United States, 58102

Contacts

Study Coordinator

701-234-2000

Ohio State University Comprehensive Cancer Center ( Site 0015)

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Study Coordinator

614-366-0233

Abramson Cancer Center of the University of Pennsylvania ( Site 0010)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

215-220-9703

Sanford Cancer Center ( Site 0038)

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Study Coordinator

605-328-8000

The University of Texas MD Anderson Cancer Center ( Site 0009)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-792-6363

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-25.