Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
NCT06731478 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 726 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06731478 reports 20 study locations spanning 16 distinct geographic areas — top geographies include New York, Texas, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06731478?
The interventions under investigation include: Trastuzumab (DRUG), pembrolizumab (DRUG), Chemotherapy (DRUG), Trastuzumab Deruxtecan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06731478?
This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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