A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

NCT Number	NCT06764875
Lead Sponsor	AstraZeneca
Conditions	HER2-positive Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Enrollment	840 participants
Start Date	2025-03-01
Primary Completion	2029-04-27 (estimated)
Study Completion	2030-12-09 (estimated)
Updated on ClinicalTrials.gov	2026-06-16