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NCT06731478 · ClinicalTrials.gov registry record · Phase 3
Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
A Phase 3 study of Gastric Cancer and Gastroesophageal-junction Cancer, sponsored by Daiichi Sankyo.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 726
- Enrollment target
- 20
- Study locations
NCT06731478 is a Phase 3 study of Gastric Cancer and Gastroesophageal-junction Cancer that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 726 participants, above the 315-participant average among 153 other Gastric Cancer trials with a reported enrollment target (130% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT06731478, a Phase 3 study of Gastric Cancer and Gastroesophageal-junction Cancer, is actively recruiting participants, sponsored by Daiichi Sankyo.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 726 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG pembrolizumab
- DRUG Chemotherapy
- DRUG Trastuzumab Deruxtecan
Study Locations (20)
New York
- Memorial Sloan Kettering Cancer Center - MAIN - New York
- Montefiore Medical Center - The Bronx
Texas
- UT Southwestern Medical Center - Dallas
- Texas Oncology, P.A. - Tyler - Tyler
Virginia
- Virginia Oncology Associates - Norfolk
- Blue Ridge Cancer Care - Roanoke
Other
- CEMIC Ciudad Autonoma - Buenos Aires
- Instituto Medico Especializado Alexander Fleming - Buenos Aires
Connecticut
- Yale Cancer Center - New Haven
Illinois
- Orchard Healthcare Research Inc. - Skokie
Kansas
- University of Kansas Medical Center Research Institute, Inc. - Kansas City
Maryland
- Maryland Oncology Hematology, P.A. - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 726 participants |
| Start Date | 2025-02-27 |
| Est. Completion | 2030-02-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06731478
The ClinicalTrials.gov registry entry for NCT06731478 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 726 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 315-participant average among 153 other Gastric Cancer trials with a reported enrollment target (130% higher). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 4 interventions - of which Trastuzumab is the first listed.
NCT06731478 reports 20 study locations spanning 16 distinct geographic areas - top geographies include New York, Texas, Virginia.
Frequently Asked Questions
What is clinical trial NCT06731478 about?
NCT06731478 is a clinical study titled "Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer". 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 partici...
What is the current status of trial NCT06731478?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 726 participants. The study started on 2025-02-27. Estimated completion is 2030-02-01.
What conditions does trial NCT06731478 study?
This clinical trial studies the following conditions: Gastric Cancer, Gastroesophageal-junction Cancer.
What interventions are being tested in trial NCT06731478?
The interventions under investigation include: Trastuzumab (DRUG), pembrolizumab (DRUG), Chemotherapy (DRUG), Trastuzumab Deruxtecan (DRUG).
Who is sponsoring clinical trial NCT06731478?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06731478 being conducted?
This trial has 20 study locations across Connecticut, Illinois, Kansas, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.