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 (May 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
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
Required: PD-L1 (CD274) expression (CPS (Combined Positive Score) tested; no threshold specified)
tumor sample for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 CPS, and other correlatives
Disease stage
Metastatic disease required
Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma
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 symptomatic CHF (NYHA II-IV); no MI within 6 months; 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 (New York Heart Association Class II to IV). Has a corrected QT interval (QTcF) prolongation to >470 ms (females) or >450 ms (males) based on the average of the screening triplicate 12-lead ECG.
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 →
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