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A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
Sponsor: AstraZeneca
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
840
Start Date
2025-03-01
Completion Date
2030-12-09
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
Rilvegostomig
Q3W, intravenous infusion
Trastuzumab deruxtecan
Q3W, intravenous infusion
Trastuzumab
Q3W, intravenous infusion
Pembrolizumab
Q3W, intravenous infusion
5-fluorouracil
Q3W, intravenous infusion
Capecitabine
BID, oral administration
Cisplatin
Q3W, intravenous infusion
Oxaliplatin
Q3W, intravenous infusion
Locations (286)
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Anchorage, Alaska, United States
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Phoenix, Arizona, United States
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Duarte, California, United States
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La Jolla, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Santa Monica, California, United States
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Solvang, California, United States
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Upland, California, United States
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Walnut Creek, California, United States
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Aurora, Colorado, United States
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Newark, Delaware, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Hinsdale, Illinois, United States
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Niles, Illinois, United States
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Dyer, Indiana, United States
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Louisville, Kentucky, United States
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Silver Spring, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Burnsville, Minnesota, United States
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Kansas City, Missouri, United States
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Reno, Nevada, United States
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Buenos Aires, Argentina
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Darlinghurst, Australia
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Edegem, Belgium
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Barretos, Brazil
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand
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Bangkok, Thailand
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Banphaeo, Thailand
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Dusit, Thailand
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Khon Kaen, Thailand
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Muang, Thailand
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Ankara, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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Erzurum, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Mezitli, Turkey (Türkiye)
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Cambridge, United Kingdom
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Coventry, United Kingdom
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Dundee, United Kingdom
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Hanoi, Vietnam
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Vinh, Vietnam