Trials / Recruiting
RecruitingNCT06764875
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 840 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rilvegostomig | Q3W, intravenous infusion |
| DRUG | Trastuzumab deruxtecan | Q3W, intravenous infusion |
| DRUG | Trastuzumab | Q3W, intravenous infusion |
| DRUG | Pembrolizumab | Q3W, intravenous infusion |
| DRUG | 5-fluorouracil | Q3W, intravenous infusion |
| DRUG | Capecitabine | BID, oral administration |
| DRUG | Cisplatin | Q3W, intravenous infusion |
| DRUG | Oxaliplatin | Q3W, intravenous infusion |
Timeline
- Start date
- 2025-03-01
- Primary completion
- 2029-04-27
- Completion
- 2030-12-09
- First posted
- 2025-01-09
- Last updated
- 2026-04-09
Locations
286 sites across 28 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06764875. Inclusion in this directory is not an endorsement.