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.

Trial Details

NCT ID

NCT06764875

Phase

PHASE3

Sponsor

AstraZeneca

Status

RECRUITING

Cancer Type

Gastric Cancer

Interventions

Rilvegostomig
Trastuzumab deruxtecan
Trastuzumab
Pembrolizumab
5-fluorouracil
Capecitabine

Locations (sample)

Anchorage, Alaska, United States|61.21806,-149.90028
Phoenix, Arizona, United States|33.44838,-112.07404
Duarte, California, United States|34.13945,-117.97729
La Jolla, California, United States|32.84727,-117.2742
Los Alamitos, California, United States|33.80307,-118.07256

Key Eligibility Criteria

HER2 positive for gastric cancer on a tumor biopsy.
PD-L1 combined positive score (CPS) ≥ 1.
Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.
Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.

For full eligibility, visit ClinicalTrials.gov.

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