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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)

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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: 13 Nov 2025

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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

  • 10 Nov 2025 Planned End Date changed from 1 Feb 2026 to 31 Aug 2026.
  • 10 Nov 2025 Planned primary completion date changed from 1 Oct 2025 to 31 Aug 2026.
  • 31 May 2025 According to a Daiichi Sankyo Company Media Release, Results will be presented today as a late-breaking oral presentation (LBA #4002) at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting and simultaneously published in The New England Journal of Medicine.

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