Study of Rilvegostomig for HER2-positive Gastric Cancer

This study is looking at new ways to treat HER2-positive gastric cancer (stomach cancer) or gastroesophageal junction adenocarcinoma (cancer where the esophagus meets the stomach). You might be able to join if your cancer is HER2-positive and has a PD-L1 combined positive score (CPS) of 1 or higher, and you haven't received treatment for it yet. The study is comparing different combinations of medicines: rilvegostomig with fluoropyrimidine and trastuzumab deruxtecan, against trastuzumab with chemotherapy and pembrolizumab. There's also a group looking at rilvegostomig with trastuzumab and chemotherapy. The main goals are to see how long people live without their cancer getting worse (progression-free survival) and how long people live overall (overall survival), both measured for up to about 6 years. This study is currently recruiting 840 participants.

Study design
This is a Phase 3, randomized, open-label, Sponsor-blinded study with three groups, involving 840 participants globally.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 6 years to measure how long they live without their cancer getting worse and how long they live overall.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06764875

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~840 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:RilvegostomigTrastuzumab deruxtecanTrastuzumabPembrolizumab5-fluorouracilCapecitabine

At a glance

Recruiting sites
243 of 293 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over Up to approximately 6 years
+1 more outcome measured
HER2-positive Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
293 sites across 59 states
China39
Japan25
Germany18
France10
California9
Brazil9
South Korea9
Taiwan9
AstraZeneca Clinical Study Information Center
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  • Progression free survival (PFS)Up to approximately 6 years

    PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause.

  • Overall Survival (OS)Up to approximately 6 years

    OS is defined as time from randomization until the date of death due to any cause.