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

Study Summary

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.

Conditions

HER2-positive Gastric Cancer Gastroesophageal Junction Adenocarcinoma

Interventions / Drugs

Rilvegostomig Trastuzumab deruxtecan Trastuzumab Pembrolizumab 5-fluorouracil Capecitabine Cisplatin Oxaliplatin

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment840 participants

Primary Completion—

Lead SponsorAstraZeneca

Data Retrieved2026-04-11 02:55:19.909920+00:00

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