Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
Public ClinicalTrials.gov record NCT06731478. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06731478
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 726 participants
Conditions and interventions
Conditions
Interventions
- Trastuzumab Deruxtecan Drug
- pembrolizumab Drug
- Trastuzumab Drug
- Chemotherapy Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 26, 2025
- Primary completion
- May 31, 2028
- Completion
- Jan 31, 2030
- Last update posted
- Aug 9, 2026
2025 – 2030
United States locations
- U.S. sites
- 18
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06511 | Not yet recruiting |
| Orchard Healthcare Research Inc. | Skokie | Illinois | 60077 | Recruiting |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | 66160 | Not yet recruiting |
| Maryland Oncology Hematology, P.A. | Silver Spring | Maryland | 20904 | Not yet recruiting |
| Tufts Medical Center | Boston | Massachusetts | 02111 | Recruiting |
| University of Michigan Comprehensive Cancer Center Michigan Medicine | Ann Arbor | Michigan | 48109 | Recruiting |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55404 | Withdrawn |
| Memorial Sloan Kettering Cancer Center - MAIN | New York | New York | 10065 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10467 | Recruiting |
| Providence Portland Medical Center | Portland | Oregon | 97213 | Recruiting |
| Penn State University Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | Recruiting |
| Prisma Health Cancer Institute, ITOR, CRU | Greenville | South Carolina | 29605 | Recruiting |
| Tennessee Oncology Nashville Midtown | Nashville | Tennessee | 37203 | Withdrawn |
| UT Southwestern Medical Center | Dallas | Texas | 75235 | Recruiting |
| Texas Oncology, P.A. - Tyler | Tyler | Texas | 75702 | Not yet recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | 23502-1871 | Not yet recruiting |
| Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | Not yet recruiting |
| Wenatchee Valley Hospital & Clinics | Wenatchee | Washington | 98801 | Withdrawn |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 231 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06731478, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06731478 live on ClinicalTrials.gov.