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)

Running, not enrolling · Phase 3

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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%).

Key facts

Study ID

NCT05609968

Run by

Merck Sharp & Dohme LLC

People needed

614

Starts

2023-02-06

Expected to finish

2028-08-23

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• The main exclusion criteria include but are not limited to the following:
• Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
• Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC
• Has previously received treatment with Topoisomerase 1 inhibitors or Trop-2 targeted therapy
• Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
• Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities requiring corticosteroids
• Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study intervention
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
• Has cardiac disease
• Myocardial infarction or unstable angina pectoris within 6 months of enrollment
• History of serious ventricular arrhythmia, high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications; history of QT interval prolongation
• New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of <40%
• Has active chronic inflammatory bowel disease
• Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab or sacituzumab govitecan and/or any of their excipients
• Has active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has active infection requiring systemic therapy
• Has history of human immunodeficiency virus (HIV) infection
• History of hepatitis B or known active hepatitis C virus infection
• Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
• Have not adequately recovered from major surgery or have ongoing surgical complications

Where it is running

• Profound Research LLC ( Site 0444) — Oceanside, California, United States
• Clermont Oncology Center ( Site 0421) — Clermont, Florida, United States
• University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417) — Miami, Florida, United States
• Mid Florida Hematology and Oncology Center ( Site 0416) — Orange City, Florida, United States
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407) — Marietta, Georgia, United States
• Our Lady of the Lake RMC ( Site 0424) — Baton Rouge, Louisiana, United States
• Henry Ford Hospital ( Site 0412) — Detroit, Michigan, United States
• Profound Research LLC ( Site 0440) — Farmington Hills, Michigan, United States
• Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0425) — Minneapolis, Minnesota, United States
• Basil Clinical ( Site 0441) — Inwood, New York, United States
• White Plains Hospital-Center for Cancer Care ( Site 0403) — White Plains, New York, United States
• Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408) — Portland, Oregon, United States
• Oregon Health & Science University ( Site 0427) — Portland, Oregon, United States
• Houston Methodist Hospital ( Site 0419) — Houston, Texas, United States
• Central Texas Veterans health care ( Site 0414) — Temple, Texas, United States
• Orange Hospital-Clinical Trials Unit ( Site 0600) — Orange, New South Wales, Australia
• Cancer Research SA-St Andrews Hospital ( Site 0603) — Adelaide, South Australia, Australia
• Frankston Hospital-Oncology and Haematology ( Site 0601) — Frankston, Victoria, Australia
• CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0320) — Fortaleza, Ceará, Brazil
• Hospital Tacchini ( Site 0322) — Bento Gonçalves, Rio Grande do Sul, Brazil
• Hospital da Cidade de Passo Fundo ( Site 0321) — Passo Fundo, Rio Grande do Sul, Brazil
• Instituto de Oncologia Saint Gallen ( Site 0317) — Santa Cruz do Sul, Rio Grande do Sul, Brazil
• Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0318) — Barretos, São Paulo, Brazil
• A. C. Camargo Cancer Center ( Site 0324) — São Paulo, Brazil
• Infirmary Cancer Care ( Site 0418) — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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