Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Trastuzumab Deruxtecan: T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
pembrolizumab: Pembrolizumab will be administered at a dose of 200 mg IV Q3W
Trastuzumab: Trastuzumab will be administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg IV Q3W
Chemotherapy: For Arms M1 and E1: 5-FU or capecitabine will be administered. For Arms M2 and E2: Cisplatin plus 5-FU or oxaliplatin plus capecitabine will be administered.
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.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — From date of randomization to the date of radiographic disease progression or death due to any cause, up to 59 months
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.
Trial sites (250)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | Not Yet Recruiting |
| Orchard Healthcare Research Inc. | Skokie | Illinois | Recruiting |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | Not Yet Recruiting |
| Maryland Oncology Hematology, P.A. | Silver Spring | Maryland | Not Yet Recruiting |
| Tufts Medical Center | Boston | Massachusetts | Recruiting |
| University of Michigan Comprehensive Cancer Center Michigan Medicine | Ann Arbor | Michigan | Recruiting |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | Withdrawn |
| Memorial Sloan Kettering Cancer Center - MAIN | New York | New York | Recruiting |
| Montefiore Medical Center | The Bronx | New York | Recruiting |
| Providence Portland Medical Center | Portland | Oregon | Recruiting |
| Penn State University Milton S. Hershey Medical Center | Hershey | Pennsylvania | Recruiting |
| Prisma Health Cancer Institute, ITOR, CRU | Greenville | South Carolina | Recruiting |
| Tennessee Oncology Nashville Midtown | Nashville | Tennessee | Withdrawn |
| UT Southwestern Medical Center | Dallas | Texas | Recruiting |
| Texas Oncology, P.A. - Tyler | Tyler | Texas | Not Yet Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | Not Yet Recruiting |
| Blue Ridge Cancer Care | Roanoke | Virginia | Not Yet Recruiting |
| Wenatchee Valley Hospital & Clinics | Wenatchee | Washington | Withdrawn |
| CEMIC Ciudad Autonoma | Buenos Aires | Argentina | Not Yet Recruiting |
| Instituto Medico Especializado Alexander Fleming | Buenos Aires | Argentina | Recruiting |
| Clinica Universitaria Privada Reina Fabiola | Córdoba | Argentina | Recruiting |
| Centro de Investigaciones Medicas Mar del Plata | Mar del Plata | Argentina | Recruiting |
| Instituto Medico de la Fundacion Estudios Clinicos | Rosario | Argentina | Recruiting |
| Flinders Medical Centre | Bedford Park | Australia | Recruiting |
| Monash Medical Centre Clayton | Clayton | Australia | Recruiting |
| Townsville University Hospital | Douglas | Australia | Recruiting |
| Peter MacCallum Cancer Centre | North Melbourne | Australia | Recruiting |
| GenesisCare North Shore (Oncology) | St Leonards | Australia | Recruiting |
| St John of God Subiaco Hospital | Subiaco | Australia | Recruiting |
| Wollongong Hospital | Wollongong | Australia | Recruiting |
| LKH - Universitaetsklinikum Graz | Graz | Austria | Recruiting |
| Medizinische Universität Innsbruck | Innsbruck | Austria | Recruiting |
| Medizinische Universität Wien | Vienna | Austria | Recruiting |
| St. Josef Krankenhaus Wien | Vienna | Austria | Recruiting |
| Landesklinikum Wiener Neustadt | Wiener Neustadt | Austria | Recruiting |
| Institut Jules Bordet | Anderlecht | Belgium | Recruiting |
| AZ Sint-Lucas | Bruges | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liege | Liège | Belgium | Recruiting |
+ 210 more sites — see the full list on the official registry below.
On this site
📄 Enhertu (trastuzumab deruxtecan) drug profile → 📄 Keytruda (pembrolizumab) drug profile → 📄 Herceptin (trastuzumab) drug profile →More Daiichi Sankyo trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06731478 on ClinicalTrials.gov ↗ ← All trials in Italy