Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
Recruiting · Phase 3 · NCT06731478
Conditions: Gastric Cancer, Gastroesophageal Junction Cancer
At a glance
- Research payments reported, 2025
- $57,456
- U.S. investigators named
- 3
- Sites paid
- 3
- Planned or actual enrollment
- 726
About the trial
- Sponsor
- Daiichi Sankyo (with Merck Sharp & Dohme LLC)
- Tested
- Trastuzumab Deruxtecan (drug), pembrolizumab (drug), Trastuzumab (drug), Chemotherapy (drug)
- Dates
- Started 2025-02-27; completion 2030-02-01
- Results posted
- Not yet
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 GE…
From ClinicalTrials.gov, last updated 2026-08-10. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Daiichi Sankyo Inc. reported $57,456 in research payments for this study in 2025 (12 payments).
Products named: Enhertu
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Ira A. Oliff, MD Hematology & Oncology · Skokie, IL
- Rom S. Leidner, MD Medical Oncology · Portland, OR
- Mark D. Kochenderfer, MD Hematology & Oncology · Roanoke, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Providence Health & Services Oregon $31,200
- Orchard Healthcare Research $18,156
- Sarah Cannon Research Institute $8,100
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.