drugset / Trial / NCT06764875
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2025-03-01
- Primary completion
- 2029-04-27
- Completion
- 2030-12-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | Oral |
| Comparator | Cisplatin | Other / unclassified | — | Intravenous |
| Comparator | Oxaliplatin | Small molecule | — | Intravenous |
| Comparator | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Subject | Rilvegostomig | Other / unclassified | — | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | — | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | — | Intravenous |
| Subject | fluorouracil | Small molecule | — | Intravenous |