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) (NCT05609968)
An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator-Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater Than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTE D46/EVOKE-03)
🩺 Plain-English Summary (8th-Grade Level)
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%).
Who can join: Review the eligibility criteria below.
Location: Infirmary Cancer Care ( Site 0418) — Mobile, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (180 Sites)
Showing the first 25 of 180 sites.
- 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
- Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408) — Portland, Oregon
- Oregon Health & Science University ( Site 0427) — Portland, Oregon
- Houston Methodist Hospital ( Site 0419) — Houston, Texas
- Central Texas Veterans health care ( Site 0414) — Temple, Texas
- Orange Hospital-Clinical Trials Unit ( Site 0600) — Orange, New South Wales
- Cancer Research SA-St Andrews Hospital ( Site 0603) — Adelaide, South Australia
- Frankston Hospital-Oncology and Haematology ( Site 0601) — Frankston, Victoria
- CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0320) — Fortaleza, Ceará
- Hospital Tacchini ( Site 0322) — Bento Gonçalves, Rio Grande do Sul
- Hospital da Cidade de Passo Fundo ( Site 0321) — Passo Fundo, Rio Grande do Sul
- Instituto de Oncologia Saint Gallen ( Site 0317) — Santa Cruz do Sul, Rio Grande do Sul
- Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0318) — Barretos, São Paulo
- A. C. Camargo Cancer Center ( Site 0324) — São Paulo,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Carcinoma, Non-Small-Cell Lung
- MYLUNG Consortium Study Protocol 2 — Daphne, Alabama
- A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) — Des Moines, Iowa
- THIO Sequenced With Cemiplimab in Advanced NSCLC — Birmingham, Alabama
- A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions — Duarte, California
- Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study — La Jolla, California
- A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) — Los Angeles, California
Explore by condition: All Carcinoma, Non-Small-Cell Lung clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.