A Phase 3 Study of Trastuzumab Deruxtecan Plus Chemotherapy With or Without Pembrolizumab Versus Trastuzumab Plus Chemotherapy With or Without Pembrolizumab in People With Gastric or Gastroesophageal Junction Cancers

Full 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)

Purpose

Researchers are comparing several combination drug treatments for people with cancer of the stomach or gastroesophageal junction (GEJ). The people in this study have gastric or GEJ cancer that metastasized (spread) or is inoperable (cannot be surgically removed). In addition, their tumors make a protein called HER2.

If you take part in this study, you will be randomly assigned to get one of these treatments. Your placement also depends on the level of a protein called PD-L1 in your tumor.

  • Trastuzumab deruxtecan (T-DXd) plus chemotherapy (5-fluorouracil, capecitabine, cisplatin, or oxaliplatin) and pembrolizumab immunotherapy
  • Trastuzumab plus chemotherapy and pembrolizumab
  • T-DXd plus chemotherapy
  • Trastuzumab plus chemotherapy

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic or inoperable HER2-positive gastric or GEJ cancer.
  • Have recovered from the serious side effects of prior treatments before entering the study.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Yelena Janjigian at 646-888-4286.

Protocol

25-227

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06731478