Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

Summary

This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy.

Timeline

Start

2021-05-21

Primary completion

2026-08-31

Completion

2026-08-31

Publications

• Shitara K, Van Cutsem E, Gumus M, Lonardi S, de la Fouchardiere C, Coutzac C, Dekervel J, Hochhauser D, Shen L, Mansoor W, Liu B, Fornaro L, Ryu MH, Lee J, Faustino C, Metges JP, Tabernero J, Franke F, Janjigian YY, Souza F, Jukofsky L, Zhao Y, Kamio T, Zaanan A, Pietrantonio F; DESTINY-Gastric04 Trial Investigators. Trastuzumab Deruxtecan or Ramucirumab plus Paclitaxel in Gastric Cancer. N Engl J Med. 2025 Jul 24;393(4):336-348. doi: 10.1056/NEJMoa2503119. Epub 2025 May 31.
• Yu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036.

Drugs

Indications