Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)
The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 24, 2025 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Merck Sharp & Dohme LLC
- Interventions being studied
- Biological: Sacituzumab Govitecan; Biological: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- The main inclusion criteria include but are not limited to the following:
- Has a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
- Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase 1 (ALK-1), or ROS proto-oncogene 1 (ROS-1)-directed therapy is not indicated as primary therapy
- Has provided tumor tissue that demonstrates PD-L1 tumor proportion score (TPS) ≥50% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
- Has a life expectancy of at least 3 months
The main
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Infirmary Cancer Care ( Site 0418)Mobile, Alabama
- Profound Research LLC ( Site 0444)Oceanside, California
- Clermont Oncology Center ( Site 0421)Clermont, Florida
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417)Miami, Florida
- Mid Florida Hematology and Oncology Center ( Site 0416)Orange City, Florida
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407)Marietta, Georgia
- Our Lady of the Lake RMC ( Site 0424)Baton Rouge, Louisiana
- Henry Ford Hospital ( Site 0412)Detroit, Michigan
- Profound Research LLC ( Site 0440)Farmington Hills, Michigan
- Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0425)Minneapolis, Minnesota
- Basil Clinical ( Site 0441)Inwood, New York
- White Plains Hospital-Center for Cancer Care ( Site 0403)White Plains, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 24, 2025. Always confirm current availability with the study team.