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)
2 other identifiers
interventional
840
27 countries
282
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2025
Longer than P75 for phase_3
282 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2024
CompletedFirst Posted
Study publicly available on registry
January 9, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 9, 2030
April 9, 2026
April 1, 2026
4.2 years
December 12, 2024
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Progression free survival (PFS)
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause.
Up to approximately 6 years
Overall Survival (OS)
OS is defined as time from randomization until the date of death due to any cause.
Up to approximately 6 years
Secondary Outcomes (13)
Objective Response Rate (ORR)
Up to approximately 6 years
Duration of Response (DoR)
Up to approximately 6 years
Proportion of all randomized participants alive and progression-free at 6 months (PFS6)
Up to 6 months
Proportion of all randomized participants alive and progression-free at 12 months (PFS12)
Up to 12 months
Time to second progression or death (PFS2)
Up to approximately 6 years
- +8 more secondary outcomes
Study Arms (3)
Arm A
EXPERIMENTALT-DXd + Rilvegostomig + Fluoropyrimidine (Capecitabine OR 5-FU)
Arm B
ACTIVE COMPARATORPembrolizumab + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)
Arm C
ACTIVE COMPARATORRilvegostomig + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- LVEF ≥ 50% within 28 days before randomization.
- Adequate treatment washout period before randomization.
You may not qualify if:
- Lack of physiological integrity of the upper gastrointestinal tract.
- Known dihydropyrimidine dehydrogenase enzyme deficiency.
- Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence.
- Persistent toxicities caused by previous anti-cancer therapy.
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
- Uncontrolled infection including tuberculosis and active hepatitis A infection.
- Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.
- Recent receipt of live, attenuated vaccine.
- Chronic/active HBV or HCV infection unless controlled.
- Clinically significant cardiac or psychological conditions.
- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
- History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Lung-specific intercurrent clinically significant illnesses.
- Any active non-infectious skin disease requiring systemic treatment.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (286)
Research Site
Anchorage, Alaska, 99508, United States
Research Site
Phoenix, Arizona, 85054, United States
Research Site
Duarte, California, 91010, United States
Research Site
La Jolla, California, 92037, United States
Research Site
Los Alamitos, California, 90720, United States
Research Site
Los Angeles, California, 90089, United States
Research Site
Santa Monica, California, 90404, United States
Research Site
Solvang, California, 93463, United States
Research Site
Upland, California, 91786, United States
Research Site
Walnut Creek, California, 94598, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Newark, Delaware, 19713, United States
Research Site
Jacksonville, Florida, 32207, United States
Research Site
Jacksonville, Florida, 32224, United States
Research Site
Orlando, Florida, 32806, United States
Research Site
Marietta, Georgia, 30060, United States
Research Site
Chicago, Illinois, 60612, United States
Research Site
Chicago, Illinois, 60637, United States
Research Site
Evanston, Illinois, 60201, United States
Research Site
Hinsdale, Illinois, 60521, United States
Research Site
Niles, Illinois, 60714, United States
Research Site
Dyer, Indiana, 46311, United States
Research Site
Louisville, Kentucky, 40217, United States
Research Site
Silver Spring, Maryland, 20904, United States
Research Site
Boston, Massachusetts, 02114, United States
Research Site
Boston, Massachusetts, 02118, United States
Research Site
Detroit, Michigan, 48202, United States
Research Site
Grand Rapids, Michigan, 49503, United States
Research Site
Burnsville, Minnesota, 55337, United States
Research Site
Kansas City, Missouri, 64111, United States
Research Site
St Louis, Missouri, 63108, United States
Research Site
Omaha, Nebraska, 68198-5885, United States
Research Site
Reno, Nevada, 89502, United States
Research Site
Summit, New Jersey, 07901, United States
Research Site
Santa Fe, New Mexico, 87505, United States
Research Site
New Hyde Park, New York, 11042, United States
Research Site
New York, New York, 10021, United States
Research Site
Cincinnati, Ohio, 45220, United States
Research Site
Columbus, Ohio, 43210, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Knoxville, Tennessee, 37909, United States
Research Site
Nashville, Tennessee, 37232, United States
Research Site
Dallas, Texas, 75246, United States
Research Site
Webster, Texas, 77598, United States
Research Site
Charlottesville, Virginia, 22908, United States
Research Site
Fairfax, Virginia, 22031, United States
Research Site
Fairfax, Virginia, 22031, United States
Research Site
Richmond, Virginia, 23235, United States
Research Site
Charleston, West Virginia, 25304, United States
Research Site
Madison, Wisconsin, 53792, United States
Research Site
Buenos Aires, 1264, Argentina
Research Site
Ciudad Autónoma Buenos Aires, C1430EFA, Argentina
Research Site
Ciudad de Buenos Aires, 1280, Argentina
Research Site
Rosario, 2123, Argentina
Research Site
Rosario, S2000DEJ, Argentina
Research Site
Viedma, R8500ACE, Argentina
Research Site
Darlinghurst, 2010, Australia
Research Site
Heidelberg, 3084, Australia
Research Site
Murdoch, 6150, Australia
Research Site
Westmead, 2145, Australia
Research Site
Linz, 4010, Austria
Research Site
Salzburg, 5020, Austria
Research Site
Vienna, 1090, Austria
Research Site
Wiener Neustadt, 2700, Austria
Research Site
Edegem, 2650, Belgium
Research Site
Ghent, 9000, Belgium
Research Site
Leuven, 3000, Belgium
Research Site
Liège, 4000, Belgium
Research Site
Barretos, 14784-057, Brazil
Research Site
Brasília, 71681-603, Brazil
Research Site
Campo Grande, 79020-180, Brazil
Research Site
Natal, 59075-740, Brazil
Research Site
Porto Alegre, 91350-200, Brazil
Research Site
Recife, 50040-000, Brazil
Research Site
Salvador, 40170-110, Brazil
Research Site
São Paulo, 05652-9000, Brazil
Research Site
Vitória, 29043-272, Brazil
Research Site
Calgary, Alberta, T2N 5G2, Canada
Research Site
Edmonton, Alberta, T6G 1Z2, Canada
Research Site
Winnipeg, Manitoba, R3E 0V9, Canada
Research Site
Barrie, Ontario, L4M 6M2, Canada
Research Site
Brampton, Ontario, L6R 3J9, Canada
Research Site
Hamilton, Ontario, L8V 5C2, Canada
Research Site
Toronto, Ontario, M5G 2M9, Canada
Research Site
Chicoutimi, Quebec, G7H 5H6, Canada
Research Site
Montreal, Quebec, H3A 1A1, Canada
Research Site
Port Montt, 5480000, Chile
Research Site
Rancagua, 2852424, Chile
Research Site
Santiago, 7500653, Chile
Research Site
Santiago, 7620002, Chile
Research Site
Santiago, 8241479, Chile
Research Site
Temuco, 4810218, Chile
Research Site
Viña del Mar, 2520598, Chile
Research Site
Anyang, 455000, China
Research Site
Beijing, 100050, China
Research Site
Beijing, CN-100730, China
Research Site
Bengbu, 233004, China
Research Site
Changchun, 130021, China
Research Site
Changsha, 410013, China
Research Site
Chengdu, 610041, China
Research Site
Fuzhou, 350001, China
Research Site
Fuzhou, 350014, China
Research Site
Guangzhou, 510060, China
Research Site
Guangzhou, 510655, China
Research Site
Guangzhou, 510700, China
Research Site
Hangzhou, 310016, China
Research Site
Harbin, 150081, China
Research Site
Hefei, 230022, China
Research Site
Hefei, 230031, China
Research Site
Jinan, 250021, China
Research Site
Kunming, 650118, China
Research Site
Lanzhou, 730000, China
Research Site
Linfen, 041099, China
Research Site
Linyi, 276001, China
Research Site
Nanchang, 330008, China
Research Site
Nanjing, 210009, China
Research Site
Nanjing, 210029, China
Research Site
Shandong, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 201114, China
Research Site
Shenyang, 110004, China
Research Site
Shenyang, 110042, China
Research Site
Shijiazhuang, 050000, China
Research Site
Tianjin, 300060, China
Research Site
Wenzhou, 325000, China
Research Site
Wuhan, 430030, China
Research Site
Xi'an, 710061, China
Research Site
Xi'an, 710068, China
Research Site
Xining, 810001, China
Research Site
Yinchuan, 750004, China
Research Site
Zhengzhou, 450008, China
Research Site
Bordeaux, 33076, France
Research Site
Caen, 14000, France
Research Site
Clermont-Ferrand, 63003, France
Research Site
Dijon, 21079, France
Research Site
Lyon, 69373, France
Research Site
Marseille, 13273, France
Research Site
Poitiers, 86021, France
Research Site
Rennes, 35000, France
Research Site
Toulouse, 31059, France
Research Site
Villejuif, 94805, France
Research Site
Augsburg, 86156, Germany
Research Site
Bad Saarow, 15526, Germany
Research Site
Berlin, 10249, Germany
Research Site
Berlin, 10707, Germany
Research Site
Berlin, 13353, Germany
Research Site
Braunschweig, 38114, Germany
Research Site
Chemnitz, 9116, Germany
Research Site
Düsseldorf, 40225, Germany
Research Site
Essen, 45122, Germany
Research Site
Frankfurt, 60488, Germany
Research Site
Göttingen, 37075, Germany
Research Site
Hamburg, 20246, Germany
Research Site
Leipzig, 04103, Germany
Research Site
Ludwigshafen, 67063, Germany
Research Site
Mannheim, 68167, Germany
Research Site
Ulm, 89081, Germany
Research Site
Hong Kong, 150001, Hong Kong
Research Site
Hong Kong, 999077, Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Shatin, 00000, Hong Kong
Research Site
Budapest, 1083, Hungary
Research Site
Budapest, 1122, Hungary
Research Site
Budapest, 1145, Hungary
Research Site
Gyöngyös, 3200, Hungary
Research Site
Győr, 9024, Hungary
Research Site
Gyula, 5700, Hungary
Research Site
Zalaegerszeg, 8900, Hungary
Research Site
Ansārinagar, 110 029, India
Research Site
Bangalore, 560027, India
Research Site
Delhi, 110029, India
Research Site
Delhi, 110085, India
Research Site
Hyderabad, 500034, India
Research Site
Kolkata, 700094, India
Research Site
Mumbai, 400012, India
Research Site
Varanasi, 221005, India
Research Site
Cagliari, 09124, Italy
Research Site
Florence, 50134, Italy
Research Site
Milan, 20162, Italy
Research Site
Naples, 80131, Italy
Research Site
Padova, 35128, Italy
Research Site
Rozzano, 20089, Italy
Research Site
Torino, 10126, Italy
Research Site
Tricase, 73039, Italy
Research Site
Akashi-shi, 673-8558, Japan
Research Site
Bunkyō City, 113-8677, Japan
Research Site
Chūōku, 104-0045, Japan
Research Site
Fukuoka, 811-1395, Japan
Research Site
Fukuoka, 812-8582, Japan
Research Site
Hidaka-shi, 350-1298, Japan
Research Site
Hirakata-shi, 573-1191, Japan
Research Site
Hiroshima, 730-8518, Japan
Research Site
Kasama-shi, 309-1793, Japan
Research Site
Kita-gun, 761-0793, Japan
Research Site
Kitaadachi-gun, 362-0806, Japan
Research Site
Kōtoku, 135-8550, Japan
Research Site
Matsuyama, 791-0280, Japan
Research Site
Niigata, 951-8566, Japan
Research Site
Osaka, 541-8567, Japan
Research Site
Osakasayama-shi, 589-8511, Japan
Research Site
Ota-shi, 373-8550, Japan
Research Site
Sakaishi, 591-8025, Japan
Research Site
Sendai, 980-8574, Japan
Research Site
Shiwa-gun, 028-3695, Japan
Research Site
Suita-shi, 565-0871, Japan
Research Site
Sunto-gun, 411-8777, Japan
Research Site
Toyoake-shi, 470-1192, Japan
Research Site
Yokohama, 232-0024, Japan
Research Site
Yokohama, 241-8515, Japan
Research Site
George Town, 10450, Malaysia
Research Site
Ipoh, 30450, Malaysia
Research Site
Kuala Lumpur, 50586, Malaysia
Research Site
Kuala Lumpur, 59100, Malaysia
Research Site
Sabak Bernam, 88996, Malaysia
Research Site
Amsterdam, 1081 HV, Netherlands
Research Site
Arnhem, 6815 AD, Netherlands
Research Site
Leiden, 2333 ZA, Netherlands
Research Site
Arequipa, AREQUIPA54, Peru
Research Site
Callao, CALLAO 02, Peru
Research Site
Lima, 15036, Peru
Research Site
Lima, LIMA 29, Peru
Research Site
Lima, Lima 34, Peru
Research Site
Lima, Lima39, Peru
Research Site
San Isidro, 15073, Peru
Research Site
Bialystok, 15-027, Poland
Research Site
Gdansk, 80-219, Poland
Research Site
Koszalin, 75-581, Poland
Research Site
Olsztyn, 10-228, Poland
Research Site
Przemyśl, 37-700, Poland
Research Site
Warsaw, 02-034, Poland
Research Site
Wroclaw, 50-556, Poland
Research Site
Rio Piedras, 00935, Puerto Rico
Research Site
Daegu, 41404, South Korea
Research Site
Goyang-si, 410-769, South Korea
Research Site
Gyeonggi-do, 13620, South Korea
Research Site
Jeonnam, 519-763, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 5505, South Korea
Research Site
Badalona, 08916, Spain
Research Site
Barcelona, 08035, Spain
Research Site
Madrid, 28034, Spain
Research Site
Madrid, 28041, Spain
Research Site
Ourense, 32005, Spain
Research Site
Santander, 39008, Spain
Research Site
Seville, 41013, Spain
Research Site
Valencia, 46010, Spain
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
Kaohsiung City, 824, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Tainan, 704, Taiwan
Research Site
Tainan, 736, Taiwan
Research Site
Taipei, 100, Taiwan
Research Site
Taipei, 112, Taiwan
Research Site
Taoyuan District, 333, Taiwan
Research Site
Bangkok, 10330, Thailand
Research Site
Bangkok, 10400, Thailand
Research Site
Bangkok, 10700, Thailand
Research Site
Banphaeo, 74120, Thailand
Research Site
Dusit, 10300, Thailand
Research Site
Khon Kaen, 40002, Thailand
Research Site
Muang, 22000, Thailand
Research Site
Ankara, 06100, Turkey (Türkiye)
Research Site
Antalya, 07100, Turkey (Türkiye)
Research Site
Diyarbakır, 21280, Turkey (Türkiye)
Research Site
Erzurum, 25240, Turkey (Türkiye)
Research Site
Istanbul, 34010, Turkey (Türkiye)
Research Site
Izmir, 35965, Turkey (Türkiye)
Research Site
Mezitli, 33200, Turkey (Türkiye)
Research Site
Cambridge, CB2 2QQ, United Kingdom
Research Site
Coventry, CV2 2DX, United Kingdom
Research Site
Dundee, DD1 9SY, United Kingdom
Research Site
London, EC1A 7BE, United Kingdom
Research Site
London, W1G 6AD, United Kingdom
Research Site
Manchester, M20 4BX, United Kingdom
Research Site
Sutton, SM2 5PT, United Kingdom
Research Site
Hanoi, 100000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Hồ Chí Minh, 700000, Vietnam
Research Site
Việt Trì, 35000, Vietnam
Research Site
Vinh, 460000, Vietnam
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The study will be conducted "Sponsor-blinded", such that intervention arm allocation is not known to Sponsor personnel.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2024
First Posted
January 9, 2025
Study Start
March 1, 2025
Primary Completion (Estimated)
April 27, 2029
Study Completion (Estimated)
December 9, 2030
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.