Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer (NCT06731478)
A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)
🩺 Plain-English Summary (8th-Grade Level)
This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \<1 gastric or GEJ cancer.
Who can join: Review the eligibility criteria below.
Location: Yale Cancer Center — New Haven, Connecticut
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 (250 Sites)
Showing the first 25 of 250 sites.
- Yale Cancer Center — New Haven, Connecticut
- Orchard Healthcare Research Inc. — Skokie, Illinois
- University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas
- Maryland Oncology Hematology, P.A. — Silver Spring, Maryland
- Tufts Medical Center — Boston, Massachusetts
- University of Michigan Comprehensive Cancer Center Michigan Medicine — Ann Arbor, Michigan
- Minnesota Oncology Hematology, P.A. — Minneapolis, Minnesota
- Memorial Sloan Kettering Cancer Center - MAIN — New York, New York
- Montefiore Medical Center — The Bronx, New York
- Providence Portland Medical Center — Portland, Oregon
- Penn State University Milton S. Hershey Medical Center — Hershey, Pennsylvania
- Prisma Health Cancer Institute, ITOR, CRU — Greenville, South Carolina
- Tennessee Oncology Nashville Midtown — Nashville, Tennessee
- UT Southwestern Medical Center — Dallas, Texas
- Texas Oncology, P.A. - Tyler — Tyler, Texas
- Virginia Oncology Associates — Norfolk, Virginia
- Blue Ridge Cancer Care — Roanoke, Virginia
- Wenatchee Valley Hospital & Clinics — Wenatchee, Washington
- CEMIC Ciudad Autonoma — Buenos Aires,
- Instituto Medico Especializado Alexander Fleming — Buenos Aires,
- Clinica Universitaria Privada Reina Fabiola — Córdoba,
- Centro de Investigaciones Medicas Mar del Plata — Mar del Plata,
- Instituto Medico de la Fundacion Estudios Clinicos — Rosario,
- Flinders Medical Centre — Bedford Park,
- Monash Medical Centre Clayton — Clayton,
📞 Contact the Study Coordinator
Phone: (908) 992-6400
Email: CTRinfo_us@daiichisankyo.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 Gastric Cancer
- A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors — Scottsdale, Arizona
- Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or Irinotecan in Patients With Advanced Gastric Cancer — Los Angeles, California
- Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) — Baltimore, Maryland
- Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer — Baltimore, Maryland
- Study for AZD4360 in Participants With Advanced Solid Tumours — Santa Monica, California
- Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma — Tampa, Florida
Explore by condition: All Gastric Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.