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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: Recruiting Phase 3 study of Gastric Cancer and Gastroesophageal-junction Cancer, sponsored by Daiichi Sankyo.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression as assessed by blinded independent central review (BICR) based on RECIST v1.1 or death due to any cause.

Conditions Studied

Gastric Cancer Gastroesophageal-junction Cancer

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

FieldValue
Enrollment Target 726 participants
Start Date 2025-02-27
Est. Completion 2030-02-01
Phase Phase 3
Daiichi Sankyo

236 total trials

What NCT06731478 shows while recruiting

NCT06731478 is an interventional study that assigns participants to a tested intervention. The registered 726 participants enrollment target is mid-sized for trials with a published cap, above the 315-participant average among 153 other Gastric Cancer trials with a reported enrollment target (130% higher).

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 names 20 study sites across 16 states, led by 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.

Learn More About Clinical Trials

Similar trials for Gastric Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06731478's enrollment target sits among peer trials

726 11th of 153 higher than 143 of 153 other Gastric Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Gastric Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06731478

Source: ClinicalTrials.gov NCT06731478, the US trial registry maintained by the National Library of Medicine. NCT06731478 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.