A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
NCT06764875 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 840
Last updated 2026-05-12
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
- DRUG
-
Q3W, intravenous infusion
- DRUG
-
Q3W, intravenous infusion
- DRUG
-
Q3W, intravenous infusion
- DRUG
-
Q3W, intravenous infusion
- DRUG
-
Q3W, intravenous infusion
- DRUG
-
BID, oral administration
- DRUG
-
Q3W, intravenous infusion
- DRUG
-
Q3W, intravenous infusion
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-01
- Primary Completion
- 2029-04-27
- Completion
- 2030-12-09
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- Chile
- China
- France
- Germany
- Hong Kong
- Hungary
- India
- Italy
- Japan
- Malaysia
- Netherlands
- Peru
- Poland
- Puerto Rico
- South Korea
- Spain
- Taiwan
- Thailand
- Turkey (Türkiye)
- United Kingdom
- Vietnam
Study Locations
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