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
Location: See all (277) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
• WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.
• Have measurable target disease assessed by the Investigator based on RECIST v1.1.
• Have adequate organ and bone marrow function within 14 days before randomization.
• LVEF ≥ 55% within 28 days before randomization.
• Adequate treatment washout period before randomization.
Locations
United States
Alaska
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Anchorage
Arizona
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Phoenix
California
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Duarte
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La Jolla
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Los Alamitos
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Los Angeles
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Santa Barbara
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Santa Monica
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Upland
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Walnut Creek
Colorado
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Aurora
Florida
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Jacksonville
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Orlando
Georgia
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Marietta
Illinois
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Arlington Heights
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Chicago
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Chicago
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Hinsdale
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Skokie
Indiana
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Dyer
Kentucky
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Louisville
Massachusetts
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Boston
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Boston
Maryland
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Silver Spring
Michigan
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Detroit
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Grand Rapids
Minnesota
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Burnsville
Missouri
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Kansas City
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St Louis
Nebraska
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Omaha
New Mexico
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Santa Fe
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Reno
New York
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New Hyde Park
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New York
Ohio
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Cincinnati
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Columbus
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Knoxville
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Nashville
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Dallas
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Webster
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Charlottesville
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Fairfax
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Fairfax
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Richmond
Wisconsin
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Madison
West Virginia
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Charleston
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Argentina
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Buenos Aires
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Ciudad De Buenos Aires
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Rosario
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Rosario
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Viedma
Australia
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Darlinghurst
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Heidelberg
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Westmead
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Linz
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Vienna
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Wiener Neustadt
Belgium
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Edegem
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Ghent
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Leuven
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Liège
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Barretos
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Barrie
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Calgary
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Chicoutimi
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Edmonton
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Hamilton
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Montreal
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Toronto
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Winnipeg
Chile
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Port Montt
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Rancagua
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Santiago
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Santiago
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Temuco
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Viña Del Mar
China
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Anyang
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Beijing
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Beijing
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Fuzhou
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Guangzhou
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Guangzhou
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Guangzhou
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Hangzhou
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Harbin
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Marseille
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Augsburg
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Berlin
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Berlin
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Berlin
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Braunschweig
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Chemnitz
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Italy
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Cagliari
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Florence
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Milan
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Fukuoka
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Hiroshima
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Yokohama
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George Town
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Ipoh
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Kuala Lumpur
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Sabak Bernam
Netherlands
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Amsterdam
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Arnhem
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Leiden
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Arequipa
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Callao
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Lima
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Lima
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Lima
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San Isidro
Poland
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Bialystok
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Olsztyn
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Przemyśl
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Daegu
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Seoul
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Madrid
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Valencia
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Kaohsiung City
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Kaohsiung City
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Taichung
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Taichung
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Tainan City
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Tainan City
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Taipei
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Taipei
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Taoyuan District
Thailand
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Bangkok
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Bangkok
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Banphaeo
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Dusit
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Khon Kaen
Turkey
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Ankara
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Antalya
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Diyarbakır
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Erzurum
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Istanbul
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Izmir
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Mezitli
United Kingdom
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Cambridge
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Coventry
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Dundee
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London
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London
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Manchester
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Sutton
Viet Nam
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Hanoi
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Hồ Chí Minh
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Ho Chi Minh City
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Việt Trì
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Vinh
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2030-12-09
Participants
Target number of participants: 840
Treatments
Experimental: Arm A
T-DXd + Rilvegostomig + Fluoropyrimidine (Capecitabine OR 5-FU)
Active_comparator: Arm B
Pembrolizumab + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)
Active_comparator: Arm C
Rilvegostomig + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca