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A Phase 3, Multicenter, 2-Arm Randomized, Open-Label Study of Trastuzumab Deruxtecan in Subjects With HER2-Positive Metastatic and/or Unresectable Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

Trial Profile

A Phase 3, Multicenter, 2-Arm Randomized, Open-Label Study of Trastuzumab Deruxtecan in Subjects With HER2-Positive Metastatic and/or Unresectable Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Apr 2026

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At a glance

  • Drugs Trastuzumab-deruxtecan (Primary) ; Paclitaxel; Ramucirumab
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DESTINY-Gastric04
  • Sponsors Daiichi Sankyo Inc

Most Recent Events

  • 23 Mar 2026 According to Daiichi Sankyo media release, the Japan Pharmaceuticals and Medical Devices Agency (PMDA) has accepted the update of the ENHERTU prescribing information following review of data from the DESTINY-Gastric04 phase 3 trial, which now expands the use of ENHERTU in Japan to include the second-line treatment of patients with HER2 positive unresectable advanced or recurrent gastric cancer.
  • 10 Feb 2026 According to AstraZeneca media release, based on this study, Enhertu has been approved in EU in Nov 2025 for Locally advanced or metastatic HER2-positive (IHC3+ or IHC2+/ISH+) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab based regimen.
  • 22 Jan 2026 Results presented in the Daiichi Sankyo media release.

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