RECRUITING

Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)

Quick Facts

Study Start:2025-02-27
Study Completion:2030-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06731478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Contact for Trial Information
CONTACT
908-992-6400
CTRinfo_us@daiichisankyo.com

Study Locations (Sites)

Yale Cancer Center
New Haven, Connecticut, 06520-8028
United States
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077
United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, 20904
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan, 48109
United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55407
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Memorial Sloan Kettering Cancer Center - MAIN
New York, New York, 10065
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Prisma Health Cancer Institute, ITOR, CRU
Greenville, South Carolina, 29605
United States
Tennessee Oncology Nashville Midtown
Nashville, Tennessee, 37203
United States
UT Southwestern Medical Center
Dallas, Texas, 75235
United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, 75702
United States
Virginia Oncology Associates
Norfolk, Virginia, 23502-1871
United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014
United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, 98801
United States

Collaborators and Investigators

Sponsor: Daiichi Sankyo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-27
Study Completion Date2030-02-01

Study Record Updates

Study Start Date2025-02-27
Study Completion Date2030-02-01

Terms related to this study

Keywords Provided by Researchers

  • Enhertu
  • Trastuzumab Deruxtecan
  • Chemotherapy
  • DS-8201a
  • HER2 positive

Additional Relevant MeSH Terms

  • Gastric Cancer
  • Gastroesophageal Junction Cancer