OncoMatch/Clinical Trials/NCT06731478
Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
Is NCT06731478 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments including Trastuzumab Deruxtecan and pembrolizumab for gastric cancer.
Treatment: Trastuzumab Deruxtecan · pembrolizumab · Trastuzumab · Chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+/ISH-positive)
Centrally determined HER2-positive (IHC 3+ or IHC 2+/ISH-positive) gastric or GEJ cancer
Prior therapy
Cannot have received: HER2-targeted therapy
Prior exposure to other HER2-targeting therapies (including ADCs)
Lab requirements
Cardiac function
LVEF ≥50% within 28 days before randomization; no history of myocardial infarction within 6 months before randomization or symptomatic CHF (NYHA Class II-IV); QTcF ≤470 ms (females) or ≤450 ms (males)
LVEF ≥50% within 28 days before randomization. Medical history of myocardial infarction within 6 months before randomization or symptomatic CHF (NYHA Class II to IV) [excluded]. Has a corrected QT interval (QTcF) prolongation to >470 ms (females) or >450 ms (males)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale Cancer Center · New Haven, Connecticut
- Orchard Healthcare Research Inc. · Skokie, Illinois
- University of Kansas Medical Center Research Institute, Inc. · Kansas City, Kansas
- Maryland Oncology Hematology, P.A. · Silver Spring, Maryland
- Tufts Medical Center · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06731478 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior HER2-targeted therapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify