A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

May 11, 2026 updated by: AstraZeneca

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

840

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1264
    - Not yet recruiting
    - Research Site
  - Ciudad Autónoma Buenos Aires, Argentina, C1430EFA
    - Recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1280
    - Recruiting
    - Research Site
  - Rosario, Argentina, S2000DEJ
    - Recruiting
    - Research Site
  - Rosario, Argentina, 2123
    - Recruiting
    - Research Site
  - Viedma, Argentina, R8500ACE
    - Recruiting
    - Research Site
Australia
- - Darlinghurst, Australia, 2010
    - Recruiting
    - Research Site
  - Heidelberg, Australia, 3084
    - Recruiting
    - Research Site
  - Murdoch, Australia, 6150
    - Recruiting
    - Research Site
  - Westmead, Australia, 2145
    - Recruiting
    - Research Site
Austria
- - Linz, Austria, 4010
    - Recruiting
    - Research Site
  - Salzburg, Austria, 5020
    - Recruiting
    - Research Site
  - Vienna, Austria, 1090
    - Recruiting
    - Research Site
  - Wiener Neustadt, Austria, 2700
    - Not yet recruiting
    - Research Site
Belgium
- - Edegem, Belgium, 2650
    - Recruiting
    - Research Site
  - Ghent, Belgium, 9000
    - Recruiting
    - Research Site
  - Leuven, Belgium, 3000
    - Recruiting
    - Research Site
  - Liège, Belgium, 4000
    - Recruiting
    - Research Site
Brazil
- - Barretos, Brazil, 14784-057
    - Recruiting
    - Research Site
  - Brasília, Brazil, 71681-603
    - Recruiting
    - Research Site
  - Campo Grande, Brazil, 79020-180
    - Recruiting
    - Research Site
  - Natal, Brazil, 59075-740
    - Withdrawn
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Recruiting
    - Research Site
  - Recife, Brazil, 50040-000
    - Recruiting
    - Research Site
  - Salvador, Brazil, 40170-110
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 05652-9000
    - Recruiting
    - Research Site
  - Vitória, Brazil, 29043-272
    - Recruiting
    - Research Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 5G2
    - Recruiting
    - Research Site
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Recruiting
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - Withdrawn
    - Research Site
- Ontario
  - Barrie, Ontario, Canada, L4M 6M2
    - Recruiting
    - Research Site
  - Brampton, Ontario, Canada, L6R 3J9
    - Not yet recruiting
    - Research Site
  - Hamilton, Ontario, Canada, L8V 5C2
    - Withdrawn
    - Research Site
  - Toronto, Ontario, Canada, M5G 2M9
    - Recruiting
    - Research Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 5H6
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H3A 1A1
    - Recruiting
    - Research Site
Chile
- - Port Montt, Chile, 5480000
    - Recruiting
    - Research Site
  - Rancagua, Chile, 2852424
    - Not yet recruiting
    - Research Site
  - Santiago, Chile, 7500653
    - Recruiting
    - Research Site
  - Santiago, Chile, 8241479
    - Recruiting
    - Research Site
  - Santiago, Chile, 7620002
    - Recruiting
    - Research Site
  - Temuco, Chile, 4810218
    - Recruiting
    - Research Site
  - Viña del Mar, Chile, 2520598
    - Recruiting
    - Research Site
China
- - Anyang, China, 455000
    - Recruiting
    - Research Site
  - Beijing, China, 100050
    - Recruiting
    - Research Site
  - Beijing, China, CN-100730
    - Recruiting
    - Research Site
  - Bengbu, China, 233004
    - Recruiting
    - Research Site
  - Changchun, China, 130021
    - Suspended
    - Research Site
  - Changsha, China, 410013
    - Recruiting
    - Research Site
  - Chengdu, China, 610041
    - Recruiting
    - Research Site
  - Fuzhou, China, 350001
    - Recruiting
    - Research Site
  - Fuzhou, China, 350014
    - Recruiting
    - Research Site
  - Guangzhou, China, 510060
    - Recruiting
    - Research Site
  - Guangzhou, China, 510700
    - Recruiting
    - Research Site
  - Guangzhou, China, 510655
    - Recruiting
    - Research Site
  - Hangzhou, China, 310016
    - Recruiting
    - Research Site
  - Harbin, China, 150081
    - Recruiting
    - Research Site
  - Hefei, China, 230022
    - Recruiting
    - Research Site
  - Hefei, China, 230031
    - Recruiting
    - Research Site
  - Jinan, China, 250021
    - Recruiting
    - Research Site
  - Kunming, China, 650118
    - Recruiting
    - Research Site
  - Lanzhou, China, 730000
    - Recruiting
    - Research Site
  - Linfen, China, 041099
    - Recruiting
    - Research Site
  - Linyi, China, 276001
    - Recruiting
    - Research Site
  - Nanchang, China, 330008
    - Recruiting
    - Research Site
  - Nanjing, China, 210009
    - Recruiting
    - Research Site
  - Nanjing, China, 210029
    - Recruiting
    - Research Site
  - Shandong, China
    - Recruiting
    - Research Site
  - Shanghai, China, 200025
    - Recruiting
    - Research Site
  - Shanghai, China, 200032
    - Recruiting
    - Research Site
  - Shanghai, China, 201114
    - Recruiting
    - Research Site
  - Shenyang, China, 110042
    - Recruiting
    - Research Site
  - Shenyang, China, 110004
    - Recruiting
    - Research Site
  - Shijiazhuang, China, 050000
    - Recruiting
    - Research Site
  - Tianjin, China, 300060
    - Recruiting
    - Research Site
  - Wenzhou, China, 325000
    - Recruiting
    - Research Site
  - Wuhan, China, 430030
    - Recruiting
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Xi'an, China, 710068
    - Recruiting
    - Research Site
  - Xining, China, 810001
    - Recruiting
    - Research Site
  - Yinchuan, China, 750004
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450008
    - Recruiting
    - Research Site
France
- - Bordeaux, France, 33076
    - Not yet recruiting
    - Research Site
  - Caen, France, 14000
    - Recruiting
    - Research Site
  - Clermont-Ferrand, France, 63003
    - Recruiting
    - Research Site
  - Dijon, France, 21079
    - Withdrawn
    - Research Site
  - Lyon, France, 69373
    - Recruiting
    - Research Site
  - Marseille, France, 13273
    - Recruiting
    - Research Site
  - Poitiers, France, 86021
    - Withdrawn
    - Research Site
  - Rennes, France, 35000
    - Recruiting
    - Research Site
  - Toulouse, France, 31059
    - Withdrawn
    - Research Site
  - Villejuif, France, 94805
    - Recruiting
    - Research Site
Germany
- - Augsburg, Germany, 86156
    - Recruiting
    - Research Site
  - Bad Saarow, Germany, 15526
    - Recruiting
    - Research Site
  - Berlin, Germany, 13353
    - Recruiting
    - Research Site
  - Berlin, Germany, 10249
    - Withdrawn
    - Research Site
  - Berlin, Germany, 10707
    - Recruiting
    - Research Site
  - Braunschweig, Germany, 38114
    - Recruiting
    - Research Site
  - Chemnitz, Germany, 9116
    - Recruiting
    - Research Site
  - Düsseldorf, Germany, 40225
    - Recruiting
    - Research Site
  - Essen, Germany, 45122
    - Recruiting
    - Research Site
  - Frankfurt, Germany, 60488
    - Recruiting
    - Research Site
  - Göttingen, Germany, 37075
    - Recruiting
    - Research Site
  - Hamburg, Germany, 20246
    - Recruiting
    - Research Site
  - Leipzig, Germany, 04103
    - Recruiting
    - Research Site
  - Ludwigshafen, Germany, 67063
    - Recruiting
    - Research Site
  - Mannheim, Germany, 68167
    - Recruiting
    - Research Site
  - Ulm, Germany, 89081
    - Recruiting
    - Research Site
Hong Kong
- - Hong Kong, Hong Kong
    - Recruiting
    - Research Site
  - Hong Kong, Hong Kong
    - Not yet recruiting
    - Research Site
  - Hong Kong, Hong Kong, 150001
    - Recruiting
    - Research Site
  - Hong Kong, Hong Kong, 999077
    - Recruiting
    - Research Site
  - Shatin, Hong Kong, 00000
    - Not yet recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1083
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1122
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1145
    - Recruiting
    - Research Site
  - Gyula, Hungary, 5700
    - Recruiting
    - Research Site
  - Gyöngyös, Hungary, 3200
    - Withdrawn
    - Research Site
  - Győr, Hungary, 9024
    - Recruiting
    - Research Site
  - Zalaegerszeg, Hungary, 8900
    - Recruiting
    - Research Site
India
- - Ansārinagar, India, 110 029
    - Not yet recruiting
    - Research Site
  - Bangalore, India, 560027
    - Not yet recruiting
    - Research Site
  - Delhi, India, 110029
    - Not yet recruiting
    - Research Site
  - Delhi, India, 110085
    - Recruiting
    - Research Site
  - Hyderabad, India, 500034
    - Recruiting
    - Research Site
  - Kolkata, India, 700094
    - Recruiting
    - Research Site
  - Mumbai, India, 400012
    - Recruiting
    - Research Site
  - Varanasi, India, 221005
    - Not yet recruiting
    - Research Site
Italy
- - Cagliari, Italy, 09124
    - Recruiting
    - Research Site
  - Florence, Italy, 50134
    - Recruiting
    - Research Site
  - Milan, Italy, 20162
    - Recruiting
    - Research Site
  - Naples, Italy, 80131
    - Recruiting
    - Research Site
  - Padova, Italy, 35128
    - Recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
  - Torino, Italy, 10126
    - Recruiting
    - Research Site
  - Tricase, Italy, 73039
    - Recruiting
    - Research Site
Japan
- - Akashi-shi, Japan, 673-8558
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 113-8677
    - Recruiting
    - Research Site
  - Chūōku, Japan, 104-0045
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 811-1395
    - Recruiting
    - Research Site
  - Hidaka-shi, Japan, 350-1298
    - Recruiting
    - Research Site
  - Hirakata-shi, Japan, 573-1191
    - Recruiting
    - Research Site
  - Hiroshima, Japan, 730-8518
    - Recruiting
    - Research Site
  - Kasama-shi, Japan, 309-1793
    - Recruiting
    - Research Site
  - Kita-gun, Japan, 761-0793
    - Recruiting
    - Research Site
  - Kitaadachi-gun, Japan, 362-0806
    - Recruiting
    - Research Site
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - Research Site
  - Matsuyama, Japan, 791-0280
    - Recruiting
    - Research Site
  - Niigata, Japan, 951-8566
    - Recruiting
    - Research Site
  - Osaka, Japan, 541-8567
    - Recruiting
    - Research Site
  - Osakasayama-shi, Japan, 589-8511
    - Recruiting
    - Research Site
  - Ota-shi, Japan, 373-8550
    - Recruiting
    - Research Site
  - Sakaishi, Japan, 591-8025
    - Recruiting
    - Research Site
  - Sendai, Japan, 980-8574
    - Recruiting
    - Research Site
  - Shiwa-gun, Japan, 028-3695
    - Recruiting
    - Research Site
  - Suita-shi, Japan, 565-0871
    - Recruiting
    - Research Site
  - Sunto-gun, Japan, 411-8777
    - Recruiting
    - Research Site
  - Toyoake-shi, Japan, 470-1192
    - Recruiting
    - Research Site
  - Yokohama, Japan, 241-8515
    - Recruiting
    - Research Site
  - Yokohama, Japan, 232-0024
    - Recruiting
    - Research Site
Malaysia
- - George Town, Malaysia, 10450
    - Recruiting
    - Research Site
  - Ipoh, Malaysia, 30450
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 50586
    - Recruiting
    - Research Site
  - Sabak Bernam, Malaysia, 88996
    - Recruiting
    - Research Site
Netherlands
- - Amsterdam, Netherlands, 1081 HV
    - Recruiting
    - Research Site
  - Arnhem, Netherlands, 6815 AD
    - Recruiting
    - Research Site
  - Leiden, Netherlands, 2333 ZA
    - Recruiting
    - Research Site
Peru
- - Arequipa, Peru, AREQUIPA54
    - Not yet recruiting
    - Research Site
  - Callao, Peru, CALLAO 02
    - Not yet recruiting
    - Research Site
  - Lima, Peru, LIMA 29
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15036
    - Not yet recruiting
    - Research Site
  - Lima, Peru, Lima 34
    - Not yet recruiting
    - Research Site
  - Lima, Peru, Lima39
    - Not yet recruiting
    - Research Site
  - San Isidro, Peru, 15073
    - Not yet recruiting
    - Research Site
Poland
- - Bialystok, Poland, 15-027
    - Withdrawn
    - Research Site
  - Gdansk, Poland, 80-219
    - Recruiting
    - Research Site
  - Koszalin, Poland, 75-581
    - Recruiting
    - Research Site
  - Olsztyn, Poland, 10-228
    - Recruiting
    - Research Site
  - Przemyśl, Poland, 37-700
    - Recruiting
    - Research Site
  - Warsaw, Poland, 02-034
    - Recruiting
    - Research Site
  - Wroclaw, Poland, 50-556
    - Not yet recruiting
    - Research Site
Puerto Rico
- - Rio Piedras, Puerto Rico, 00935
    - Recruiting
    - Research Site
South Korea
- - Daegu, South Korea, 41404
    - Recruiting
    - Research Site
  - Goyang-si, South Korea, 410-769
    - Recruiting
    - Research Site
  - Gyeonggi-do, South Korea, 13620
    - Recruiting
    - Research Site
  - Jeonnam, South Korea, 519-763
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 5505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06591
    - Recruiting
    - Research Site
Spain
- - Badalona, Spain, 08916
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08035
    - Recruiting
    - Research Site
  - Madrid, Spain, 28034
    - Recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Recruiting
    - Research Site
  - Ourense, Spain, 32005
    - Recruiting
    - Research Site
  - Santander, Spain, 39008
    - Recruiting
    - Research Site
  - Seville, Spain, 41013
    - Recruiting
    - Research Site
  - Valencia, Spain, 46010
    - Recruiting
    - Research Site
Taiwan
- - Kaohsiung City, Taiwan, 80756
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 824
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 704
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 736
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 100
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 112
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10400
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10330
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Banphaeo, Thailand, 74120
    - Recruiting
    - Research Site
  - Dusit, Thailand, 10300
    - Recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Research Site
  - Muang, Thailand, 22000
    - Not yet recruiting
    - Research Site
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06100
    - Recruiting
    - Research Site
  - Antalya, Turkey (Türkiye), 07100
    - Recruiting
    - Research Site
  - Diyarbakır, Turkey (Türkiye), 21280
    - Recruiting
    - Research Site
  - Erzurum, Turkey (Türkiye), 25240
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34010
    - Recruiting
    - Research Site
  - Izmir, Turkey (Türkiye), 35965
    - Recruiting
    - Research Site
  - Mezitli, Turkey (Türkiye), 33200
    - Recruiting
    - Research Site
United Kingdom
- - Cambridge, United Kingdom, CB2 2QQ
    - Recruiting
    - Research Site
  - Coventry, United Kingdom, CV2 2DX
    - Recruiting
    - Research Site
  - Dundee, United Kingdom, DD1 9SY
    - Recruiting
    - Research Site
  - London, United Kingdom, EC1A 7BE
    - Recruiting
    - Research Site
  - London, United Kingdom, W1G 6AD
    - Recruiting
    - Research Site
  - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - Research Site
  - Sutton, United Kingdom, SM2 5PT
    - Recruiting
    - Research Site
United States
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Recruiting
    - Research Site
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Recruiting
    - Research Site
- California
  - Duarte, California, United States, 91010
    - Recruiting
    - Research Site
  - La Jolla, California, United States, 92037
    - Recruiting
    - Research Site
  - Los Alamitos, California, United States, 90720
    - Not yet recruiting
    - Research Site
  - Los Angeles, California, United States, 90089
    - Recruiting
    - Research Site
  - Santa Monica, California, United States, 90404
    - Recruiting
    - Research Site
  - Solvang, California, United States, 93463
    - Recruiting
    - Research Site
  - Upland, California, United States, 91786
    - Recruiting
    - Research Site
  - Walnut Creek, California, United States, 94598
    - Recruiting
    - Research Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - Research Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Not yet recruiting
    - Research Site
- Florida
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Research Site
  - Jacksonville, Florida, United States, 32207
    - Not yet recruiting
    - Research Site
  - Orlando, Florida, United States, 32806
    - Recruiting
    - Research Site
- Georgia
  - Athens, Georgia, United States, 30607
    - Withdrawn
    - Research Site
  - Marietta, Georgia, United States, 30060
    - Recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - Not yet recruiting
    - Research Site
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - Research Site
  - Evanston, Illinois, United States, 60201
    - Not yet recruiting
    - Research Site
  - Hinsdale, Illinois, United States, 60521
    - Recruiting
    - Research Site
  - Niles, Illinois, United States, 60714
    - Recruiting
    - Research Site
- Indiana
  - Dyer, Indiana, United States, 46311
    - Withdrawn
    - Research Site
- Iowa
  - Waukee, Iowa, United States, 50263
    - Not yet recruiting
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40217
    - Recruiting
    - Research Site
- Maryland
  - Silver Spring, Maryland, United States, 20904
    - Recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Withdrawn
    - Research Site
  - Boston, Massachusetts, United States, 02114
    - Withdrawn
    - Research Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - Not yet recruiting
    - Research Site
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Research Site
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Recruiting
    - Research Site
- Missouri
  - Kansas City, Missouri, United States, 64111
    - Withdrawn
    - Research Site
  - St Louis, Missouri, United States, 63108
    - Recruiting
    - Research Site
- Nebraska
  - Omaha, Nebraska, United States, 68198-5885
    - Not yet recruiting
    - Research Site
- Nevada
  - Reno, Nevada, United States, 89502
    - Recruiting
    - Research Site
- New Jersey
  - Summit, New Jersey, United States, 07901
    - Not yet recruiting
    - Research Site
- New Mexico
  - Santa Fe, New Mexico, United States, 87505
    - Recruiting
    - Research Site
- New York
  - New Hyde Park, New York, United States, 11042
    - Withdrawn
    - Research Site
  - New York, New York, United States, 10021
    - Recruiting
    - Research Site
- Ohio
  - Cincinnati, Ohio, United States, 45220
    - Recruiting
    - Research Site
  - Columbus, Ohio, United States, 43210
    - Not yet recruiting
    - Research Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Not yet recruiting
    - Research Site
- Tennessee
  - Knoxville, Tennessee, United States, 37909
    - Recruiting
    - Research Site
  - Nashville, Tennessee, United States, 37232
    - Withdrawn
    - Research Site
- Texas
  - Dallas, Texas, United States, 75246
    - Recruiting
    - Research Site
  - Round Rock, Texas, United States, 78665
    - Not yet recruiting
    - Research Site
  - Webster, Texas, United States, 77598
    - Recruiting
    - Research Site
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - Recruiting
    - Research Site
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Research Site
  - Fairfax, Virginia, United States, 22031
    - Withdrawn
    - Research Site
  - Richmond, Virginia, United States, 23235
    - Withdrawn
    - Research Site
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - Recruiting
    - Research Site
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - Withdrawn
    - Research Site
Vietnam
- - Hanoi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - Research Site
  - Hồ Chí Minh, Vietnam, 700000
    - Recruiting
    - Research Site
  - Viet Tri, Vietnam, 35000
    - Recruiting
    - Research Site
  - Vinh, Vietnam, 460000
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.
A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).
History of any of the following: drug-induced severe cutaneous adverse reaction.
Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors.
Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.
Current or prior use of immunosuppressive medication within 14 days before study intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A T-DXd + Rilvegostomig + Fluoropyrimidine (Capecitabine OR 5-FU)	Drug: Rilvegostomig Q3W, intravenous infusion Other Names: AZD2936 Drug: Trastuzumab deruxtecan Q3W, intravenous infusion Other Names: T-DXd, DS-8201 Drug: 5-fluorouracil Q3W, intravenous infusion Other Names: 5-FU Drug: Capecitabine BID, oral administration
Active Comparator: Arm B Pembrolizumab + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)	Drug: 5-fluorouracil Q3W, intravenous infusion Other Names: 5-FU Drug: Capecitabine BID, oral administration Drug: Trastuzumab Q3W, intravenous infusion Drug: Pembrolizumab Q3W, intravenous infusion Drug: Cisplatin Q3W, intravenous infusion Drug: Oxaliplatin Q3W, intravenous infusion
Active Comparator: Arm C Rilvegostomig + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)	Drug: Rilvegostomig Q3W, intravenous infusion Other Names: AZD2936 Drug: 5-fluorouracil Q3W, intravenous infusion Other Names: 5-FU Drug: Capecitabine BID, oral administration Drug: Trastuzumab Q3W, intravenous infusion Drug: Cisplatin Q3W, intravenous infusion Drug: Oxaliplatin Q3W, intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS) Time Frame: Up to approximately 6 years	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) Time Frame: Up to approximately 6 years	OS is defined as time from randomization until the date of death due to any cause.	Up to approximately 6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) Time Frame: Up to approximately 6 years	ORR according to RECIST v1.1. ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR).	Up to approximately 6 years
Duration of Response (DoR) Time Frame: Up to approximately 6 years	DoR according to RECIST v1.1. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1 or death due to any cause.	Up to approximately 6 years
Proportion of all randomized participants alive and progression-free at 6 months (PFS6) Time Frame: Up to 6 months	Proportion of all randomized participants alive and progression-free at 6 months calculated for progression.	Up to 6 months
Proportion of all randomized participants alive and progression-free at 12 months (PFS12) Time Frame: Up to 12 months	Proportion of all randomized participants alive and progression-free at 12 months calculated for progression.	Up to 12 months
Time to second progression or death (PFS2) Time Frame: Up to approximately 6 years	PFS2 is defined as the time from randomization to the earliest of the progression event (following the initial progression), after the first subsequent therapy, or death, where the first objective progression includes progression occurring after 2 missed visits.	Up to approximately 6 years
Occurrence of adverse events (AEs) and serious adverse events (SAEs) Time Frame: Up to approximately 6 years	Occurrence of AEs and SAEs will be graded according to the revised NCI CTCAE v5.0.	Up to approximately 6 years
Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum Time Frame: Up to approximately 6 years	Concentration of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, fluoropyrimidine, and capecitabine in serum or plasma.	Up to approximately 6 years
Immunogenicity of rilvegostomig and T-DXd assessed by the presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd Time Frame: Up to approximately 6 years	Presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).	Up to approximately 6 years
Increase in enteral feeding assistance and eating difficulties Time Frame: Up to approximately 6 years	Time to first-confirmed worsening of eating symptoms or initiation of feeding assistance among all participants, as randomized.	Up to approximately 6 years
Proportion of time on study intervention with high side-effect bother Time Frame: Up to approximately 6 years	Proportion of time on study intervention with high side-effect bother relative to low side-effect burden as measured by the Patient Global Impression of Treatment Tolerability (PGI-TT).	Up to approximately 6 years
Overall Survival at 12 months (OS12) Time Frame: Up to 12 months	Proportion of all randomized participants alive at 12 months.	Up to 12 months
Overall Survival at 24 months (OS24) Time Frame: Up to 24 months	Proportion of all randomized participants alive at 24 months.	Up to 24 months
Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum Time Frame: Up to approximately 6 years	PK parameters (peak and trough concentrations).	Up to approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

April 27, 2029

Study Completion (Estimated)

December 9, 2030

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D702AC00001
2024-512583-57-00 (Other Identifier: EU Clinical Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

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Studies a U.S. FDA-regulated device product

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