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Study identifier: NCT06731478 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer

Condition: Gastric Cancer · Gastroesophageal Junction Cancer  ·  Sponsor: Daiichi Sankyo

PhasePhase 3
Planned participants726
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact for Trial Information  ·  908-992-6400  ·  CTRinfo_us@daiichisankyo.com

Always discuss trial participation with your own doctor first.

Locations (250)

Yale Cancer CenterNew Haven, Connecticut, United StatesNot Yet Recruiting
Orchard Healthcare Research Inc.Skokie, Illinois, United StatesRecruiting
University of Kansas Medical Center Research Institute, Inc.Kansas City, Kansas, United StatesNot Yet Recruiting
Maryland Oncology Hematology, P.A.Silver Spring, Maryland, United StatesNot Yet Recruiting
Tufts Medical CenterBoston, Massachusetts, United StatesRecruiting
University of Michigan Comprehensive Cancer Center Michigan MedicineAnn Arbor, Michigan, United StatesRecruiting
Minnesota Oncology Hematology, P.A.Minneapolis, Minnesota, United StatesWithdrawn
Memorial Sloan Kettering Cancer Center - MAINNew York, New York, United StatesRecruiting
Montefiore Medical CenterThe Bronx, New York, United StatesRecruiting
Providence Portland Medical CenterPortland, Oregon, United StatesRecruiting
Penn State University Milton S. Hershey Medical CenterHershey, Pennsylvania, United StatesRecruiting
Prisma Health Cancer Institute, ITOR, CRUGreenville, South Carolina, United StatesNot Yet Recruiting

+ 238 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06731478