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

Active:	Yes
Cancer Type:	Stomach/ Gastric Cancer Unknown Primary	NCT ID:	NCT06764875
Trial Phases:	Phase III	Protocol IDs:	D702AC00001 (primary) NCI-2025-03123 2024-512583-57-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	AstraZeneca Pharmaceuticals LP
NCI Full Details:	http://clinicaltrials.gov/show/NCT06764875

Summary

This is a Phase ?, 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.

Objectives

The purpose of this study is to assess 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.

This study will be conducted at up to 200-250 sites globally in approximately 25
countries.

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