HER2-positive Gastric CancerPhase 3NCT06764875
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
A Phase 3 study testing Rilvegostomig, Trastuzumab deruxtecan and Trastuzumab in people with HER2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by AstraZeneca at 304 sites in 28 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Rilvegostomig, Trastuzumab deruxtecan and Trastuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 304 sitesin 28 countries
- Study dates
- 1 Mar 2025to 9 Dec 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Have adequate organ and bone marrow function.
- LVEF ≥ 50% within 28 days before randomization.
- Adequate treatment washout period before randomization.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
304 sites in 28 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
304 sites in 28 countries
United States59 sites, 44 recruiting
- Recruiting
Research Site
Albany, New York, 12206
- Recruiting
Research Site
Anchorage, Alaska, 99508
- Withdrawn
Research Site
Athens, Georgia, 30607
- Recruiting
Research Site
Aurora, Colorado, 80045
- Withdrawn
Research Site
Boston, Massachusetts, 02114
- Withdrawn
Research Site
Boston, Massachusetts, 02118
- Withdrawn
Research Site
Burnsville, Minnesota, 55337
- Recruiting
Research Site
Charleston, West Virginia, 25304
- Recruiting
Research Site
Charlottesville, Virginia, 22908
- Recruiting
Research Site
Chicago, Illinois, 60612
- Withdrawn
Research Site
Chicago, Illinois, 60637
- Recruiting
Research Site
Cincinnati, Ohio, 45220
- Withdrawn
Research Site
Clifton Park, New York, 12065
- Recruiting
Research Site
Columbus, Ohio, 43221
- Recruiting
Research Site
Dallas, Texas, 75246
- Recruiting
Research Site
Detroit, Michigan, 48202
- Recruiting
Research Site
Duarte, California, 91010
- Withdrawn
Research Site
Dyer, Indiana, 46311
- Recruiting
Research Site
Evanston, Illinois, 60201
- Recruiting
Research Site
Fairfax, Virginia, 22031
- Withdrawn
Research Site
Fairfax, Virginia, 22031
- Recruiting
Research Site
Grand Rapids, Michigan, 49503
- Recruiting
Research Site
Hinsdale, Illinois, 60521
- Recruiting
Research Site
Jacksonville, Florida, 32207
- Recruiting
Research Site
Jacksonville, Florida, 32224
- Withdrawn
Research Site
Kansas City, Missouri, 64111
- Recruiting
Research Site
Knoxville, Tennessee, 37909
- Recruiting
Research Site
La Jolla, California, 92037
- Not yet recruiting
Research Site
Lancaster, Pennsylvania, 17601
- Not yet recruiting
Research Site
Lexington, Kentucky, 40536
- Recruiting
Research Site
Los Alamitos, California, 90720
- Recruiting
Research Site
Los Angeles, California, 90017
- Recruiting
Research Site
Los Angeles, California, 90089
- Recruiting
Research Site
Louisville, Kentucky, 40217
- Withdrawn
Research Site
Madison, Wisconsin, 53792
- Recruiting
Research Site
Marietta, Georgia, 30060
- Withdrawn
Research Site
Nashville, Tennessee, 37232
- Withdrawn
Research Site
New Hyde Park, New York, 11042
- Recruiting
Research Site
New York, New York, 10021
- Not yet recruiting
Research Site
Newark, Delaware, 19718
- Recruiting
Research Site
Niles, Illinois, 60714
- Withdrawn
Research Site
Oklahoma City, Oklahoma, 73104
- Recruiting
Research Site
Omaha, Nebraska, 68198-5885
- Recruiting
Research Site
Orlando, Florida, 32806
- Recruiting
Research Site
Phoenix, Arizona, 85054
- Recruiting
Research Site
Reno, Nevada, 89502
- Withdrawn
Research Site
Richmond, Virginia, 23235
- Not yet recruiting
Research Site
Round Rock, Texas, 78665
- Recruiting
Research Site
Santa Fe, New Mexico, 87505
- Recruiting
Research Site
Santa Monica, California, 90404
- Recruiting
Research Site
Silver Spring, Maryland, 20904
- Recruiting
Research Site
Solvang, California, 93463
- Recruiting
Research Site
St Louis, Missouri, 63108
- Recruiting
Research Site
Summit, New Jersey, 07901
- Recruiting
Research Site
Upland, California, 91786
- Recruiting
Research Site
Walnut Creek, California, 94598
- Not yet recruiting
Research Site
Waukee, Iowa, 50263
- Recruiting
Research Site
Webster, Texas, 77598
- Withdrawn
Research Site
Worcester, Massachusetts, 01655
China39 sites, 35 recruiting
- Recruiting
Research Site
Anyang, 455000
- Recruiting
Research Site
Beijing, 100050
- Recruiting
Research Site
Beijing, CN-100730
- Withdrawn
Research Site
Bengbu, 233004
- Terminated
Research Site
Changchun, 130021
- Recruiting
Research Site
Changsha, 410013
- Recruiting
Research Site
Chengdu, 610041
- Recruiting
Research Site
Fuzhou, 350001
- Recruiting
Research Site
Fuzhou, 350014
- Recruiting
Research Site
Guangzhou, 510060
- Recruiting
Research Site
Guangzhou, 510655
- Recruiting
Research Site
Guangzhou, 510700
- Terminated
Research Site
Hangzhou, 310016
- Recruiting
Research Site
Harbin, 150081
- Recruiting
Research Site
Hefei, 230022
- Recruiting
Research Site
Hefei, 230031
- Recruiting
Research Site
Jinan, 250021
- Withdrawn
Research Site
Kunming, 650118
- Recruiting
Research Site
Lanzhou, 730000
- Recruiting
Research Site
Linfen, 041099
- Recruiting
Research Site
Linyi, 276001
- Recruiting
Research Site
Nanchang, 330008
- Recruiting
Research Site
Nanjing, 210009
- Recruiting
Research Site
Nanjing, 210029
- Recruiting
Research Site
Shandong
- Recruiting
Research Site
Shanghai, 200025
- Recruiting
Research Site
Shanghai, 200032
- Recruiting
Research Site
Shanghai, 201114
- Recruiting
Research Site
Shenyang, 110004
- Recruiting
Research Site
Shenyang, 110042
- Recruiting
Research Site
Shijiazhuang, 050000
- Recruiting
Research Site
Tianjin, 300060
- Recruiting
Research Site
Wenzhou, 325000
- Recruiting
Research Site
Wuhan, 430030
- Recruiting
Research Site
Xi'an, 710061
- Recruiting
Research Site
Xi'an, 710068
- Recruiting
Research Site
Xining, 810001
- Recruiting
Research Site
Yinchuan, 750004
- Recruiting
Research Site
Zhengzhou, 450008
Japan25 sites, 25 recruiting
- Recruiting
Research Site
Akashi-shi, 673-8558
- Recruiting
Research Site
Bunkyō City, 113-8677
- Recruiting
Research Site
Chūōku, 104-0045
- Recruiting
Research Site
Fukuoka, 811-1395
- Recruiting
Research Site
Fukuoka, 812-8582
- Recruiting
Research Site
Hidaka-shi, 350-1298
- Recruiting
Research Site
Hirakata-shi, 573-1191
- Recruiting
Research Site
Hiroshima, 730-8518
- Recruiting
Research Site
Kasama-shi, 309-1793
- Recruiting
Research Site
Kita-gun, 761-0793
- Recruiting
Research Site
Kitaadachi-gun, 362-0806
- Recruiting
Research Site
Kōtoku, 135-8550
- Recruiting
Research Site
Matsuyama, 791-0280
- Recruiting
Research Site
Niigata, 951-8566
- Recruiting
Research Site
Osaka, 541-8567
- Recruiting
Research Site
Osakasayama-shi, 589-8511
- Recruiting
Research Site
Ota-shi, 373-8550
- Recruiting
Research Site
Sakaishi, 591-8025
- Recruiting
Research Site
Sendai, 980-8574
- Recruiting
Research Site
Shiwa-gun, 028-3695
- Recruiting
Research Site
Suita-shi, 565-0871
- Recruiting
Research Site
Sunto-gun, 411-8777
- Recruiting
Research Site
Toyoake-shi, 470-1192
- Recruiting
Research Site
Yokohama, 232-0024
- Recruiting
Research Site
Yokohama, 241-8515
Germany21 sites, 19 recruiting
- Recruiting
Research Site
Augsburg, 86156
- Recruiting
Research Site
Bad Saarow, 15526
- Withdrawn
Research Site
Berlin, 10249
- Recruiting
Research Site
Berlin, 10707
- Recruiting
Research Site
Berlin, 13353
- Recruiting
Research Site
Braunschweig, 38114
- Recruiting
Research Site
Chemnitz, 9116
- Recruiting
Research Site
Düsseldorf, 40225
- Withdrawn
Research Site
Erlangen, 91054
- Recruiting
Research Site
Essen, 45122
- Recruiting
Research Site
Frankfurt, 60488
- Recruiting
Research Site
Göttingen, 37075
- Recruiting
Research Site
Hamburg, 20246
- Recruiting
Research Site
Leipzig, 04103
- Not yet recruiting
Research Site
Lübeck, 23538
- Recruiting
Research Site
Ludwigshafen, 67063
- Not yet recruiting
Research Site
Mainz, 55131
- Recruiting
Research Site
Mannheim, 68167
- Not yet recruiting
Research Site
Regensburg, 93053
- Not yet recruiting
Research Site
Tübingen, 72076
- Recruiting
Research Site
Ulm, 89081
France11 sites, 8 recruiting
- Recruiting
Research Site
Bordeaux, 33076
- Recruiting
Research Site
Caen, 14000
- Recruiting
Research Site
Clermont-Ferrand, 63003
- Withdrawn
Research Site
Dijon, 21079
- Recruiting
Research Site
Lyon, 69373
- Recruiting
Research Site
Marseille, 13273
- Withdrawn
Research Site
Poitiers, 86021
- Recruiting
Research Site
Rennes, 35000
- Withdrawn
Research Site
Toulouse, 31059
- Not yet recruiting
Research Site
Vandœuvre-lès-Nancy, 54511
- Recruiting
Research Site
Villejuif, 94805
Canada10 sites, 8 recruiting
- Recruiting
Research Site
Barrie, Ontario, L4M 6M2
- Not yet recruiting
Research Site
Brampton, Ontario, L6R 3J9
- Recruiting
Research Site
Calgary, Alberta, T2N 5G2
- Recruiting
Research Site
Chicoutimi, Quebec, G7H 5H6
- Recruiting
Research Site
Edmonton, Alberta, T6G 1Z2
- Withdrawn
Research Site
Hamilton, Ontario, L8V 5C2
- Not yet recruiting
Research Site
Lévis, Quebec, G6V 3Z1
- Recruiting
Research Site
Montreal, Quebec, H3A 1A1
- Recruiting
Research Site
Toronto, Ontario, M5G 2M9
- Withdrawn
Research Site
Winnipeg, Manitoba, R3E 0V9
South Korea10 sites, 9 recruiting
- Recruiting
Research Site
Daegu, 41404
- Recruiting
Research Site
Goyang-si, 410-769
- Recruiting
Research Site
Gyeonggi-do, 13620
- Withdrawn
Research Site
Jeonnam, 519-763
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 03181
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 06351
- Recruiting
Research Site
Seoul, 06591
- Recruiting
Research Site
Seoul, 5505
Brazil9 sites, 8 recruiting
- Recruiting
Research Site
Barretos, 14784-057
- Recruiting
Research Site
Brasília, 71681-603
- Recruiting
Research Site
Campo Grande, 79020-180
- Withdrawn
Research Site
Natal, 59075-740
- Recruiting
Research Site
Porto Alegre, 91350-200
- Recruiting
Research Site
Recife, 50040-000
- Recruiting
Research Site
Salvador, 40170-110
- Recruiting
Research Site
São Paulo, 05652-9000
- Recruiting
Research Site
Vitória, 29043-272
Poland9 sites, 7 recruiting
- Withdrawn
Research Site
Bialystok, 15-027
- Recruiting
Research Site
Gdansk, 80-219
- Recruiting
Research Site
Koszalin, 75-581
- Recruiting
Research Site
Lodz, 93-513
- Withdrawn
Research Site
Olsztyn, 10-228
- Recruiting
Research Site
Przemyśl, 37-700
- Recruiting
Research Site
Tomaszów Mazowiecki, 97-200
- Recruiting
Research Site
Warsaw, 02-034
- Recruiting
Research Site
Wroclaw, 50-556
Taiwan9 sites, 9 recruiting
- Recruiting
Research Site
Kaohsiung City, 80756
- Recruiting
Research Site
Kaohsiung City, 824
- Recruiting
Research Site
Taichung, 40447
- Recruiting
Research Site
Taichung, 40705
- Recruiting
Research Site
Tainan, 704
- Recruiting
Research Site
Tainan, 736
- Recruiting
Research Site
Taipei, 100
- Recruiting
Research Site
Taipei, 112
- Recruiting
Research Site
Taoyuan, 333
India8 sites, 7 recruiting
- Recruiting
Research Site
Ansārinagar, 110 029
- Withdrawn
Research Site
Bangalore, 560027
- Not yet recruiting
Research Site
Delhi, 110029
- Recruiting
Research Site
Delhi, 110085
- Recruiting
Research Site
Hyderabad, 500034
- Recruiting
Research Site
Kolkata, 700094
- Recruiting
Research Site
Mumbai, 400012
- Not yet recruiting
Research Site
Varanasi, 221005
Italy8 sites, 8 recruiting
- Recruiting
Research Site
Cagliari, 09124
- Recruiting
Research Site
Florence, 50134
- Recruiting
Research Site
Milan, 20162
- Recruiting
Research Site
Naples, 80131
- Recruiting
Research Site
Padova, 35128
- Recruiting
Research Site
Rozzano, 20089
- Recruiting
Research Site
Torino, 10126
- Recruiting
Research Site
Tricase, 73039
Spain8 sites, 8 recruiting
- Recruiting
Research Site
Badalona, 08916
- Recruiting
Research Site
Barcelona, 08035
- Recruiting
Research Site
Madrid, 28034
- Recruiting
Research Site
Madrid, 28041
- Recruiting
Research Site
Ourense, 32005
- Recruiting
Research Site
Santander, 39008
- Recruiting
Research Site
Seville, 41013
- Recruiting
Research Site
Valencia, 46010
Chile7 sites, 7 recruiting
- Recruiting
Research Site
Port Montt, 5480000
- Recruiting
Research Site
Rancagua, 2852424
- Recruiting
Research Site
Santiago, 7500653
- Recruiting
Research Site
Santiago, 7620002
- Recruiting
Research Site
Santiago, 8241479
- Recruiting
Research Site
Temuco, 4810218
- Recruiting
Research Site
Viña del Mar, 2520598
Hungary7 sites, 6 recruiting
- Recruiting
Research Site
Budapest, 1083
- Recruiting
Research Site
Budapest, 1122
- Recruiting
Research Site
Budapest, 1145
- Withdrawn
Research Site
Gyöngyös, 3200
- Recruiting
Research Site
Győr, 9024
- Recruiting
Research Site
Gyula, 5700
- Recruiting
Research Site
Zalaegerszeg, 8900
Peru7 sites, 7 recruiting
- Not yet recruiting
Research Site
Arequipa, AREQUIPA54
- Not yet recruiting
Research Site
Callao, CALLAO 02
- Recruiting
Research Site
Lima, 15036
- Recruiting
Research Site
Lima, LIMA 29
- Not yet recruiting
Research Site
Lima, Lima 34
- Recruiting
Research Site
Lima, Lima39
- Recruiting
Research Site
San Isidro, 15073
Thailand7 sites, 7 recruiting
- Recruiting
Research Site
Bangkok, 10330
- Recruiting
Research Site
Bangkok, 10400
- Recruiting
Research Site
Bangkok, 10700
- Recruiting
Research Site
Banphaeo, 74120
- Recruiting
Research Site
Dusit, 10300
- Recruiting
Research Site
Khon Kaen, 40002
- Recruiting
Research Site
Muang, 22000
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Research Site
Ankara, 06100
- Recruiting
Research Site
Antalya, 07100
- Recruiting
Research Site
Diyarbakır, 21280
- Recruiting
Research Site
Erzurum, 25240
- Recruiting
Research Site
Istanbul, 34010
- Recruiting
Research Site
Izmir, 35965
- Recruiting
Research Site
Mezitli, 33200
United Kingdom7 sites, 7 recruiting
- Recruiting
Research Site
Cambridge, CB2 2QQ
- Recruiting
Research Site
Coventry, CV2 2DX
- Recruiting
Research Site
Dundee, DD1 9SY
- Recruiting
Research Site
London, EC1A 7BE
- Recruiting
Research Site
London, W1G 6AD
- Recruiting
Research Site
Manchester, M20 4BX
- Recruiting
Research Site
Sutton, SM2 5PT
Argentina6 sites, 6 recruiting
- Not yet recruiting
Research Site
Buenos Aires, 1264
- Recruiting
Research Site
Ciudad Autónoma Buenos Aires, C1430EFA
- Recruiting
Research Site
Ciudad de Buenos Aires, 1280
- Recruiting
Research Site
Rosario, 2123
- Recruiting
Research Site
Rosario, S2000DEJ
- Recruiting
Research Site
Viedma, R8500ACE
Vietnam6 sites, 6 recruiting
- Recruiting
Research Site
Hanoi, 100000
- Recruiting
Research Site
Hồ Chí Minh, 700000
- Recruiting
Research Site
Ho Chi Minh City, 70 449
- Not yet recruiting
Research Site
Ho Chi Minh City, 700000
- Recruiting
Research Site
Viet Tri, 35000
- Recruiting
Research Site
Vinh, 460000
Malaysia5 sites, 5 recruiting
- Recruiting
Research Site
George Town, 10450
- Recruiting
Research Site
Ipoh, 30450
- Recruiting
Research Site
Kuala Lumpur, 50586
- Recruiting
Research Site
Kuala Lumpur, 59100
- Recruiting
Research Site
Sabak Bernam, 88996
Australia4 sites, 4 recruiting
- Recruiting
Research Site
Darlinghurst, 2010
- Recruiting
Research Site
Heidelberg, 3084
- Recruiting
Research Site
Murdoch, 6150
- Recruiting
Research Site
Westmead, 2145
Austria4 sites, 4 recruiting
- Recruiting
Research Site
Linz, 4010
- Recruiting
Research Site
Salzburg, 5020
- Recruiting
Research Site
Vienna, 1090
- Recruiting
Research Site
Wiener Neustadt, 2700
Belgium4 sites, 4 recruiting
- Recruiting
Research Site
Edegem, 2650
- Recruiting
Research Site
Ghent, 9000
- Recruiting
Research Site
Leuven, 3000
- Recruiting
Research Site
Liège, 4000
Hong Kong3 sites, 3 recruiting
- Recruiting
Research Site
Hong Kong, 150001
- Recruiting
Research Site
Hong Kong, 999077
- Recruiting
Research Site
Hong Kong
Netherlands3 sites, 3 recruiting
- Recruiting
Research Site
Amsterdam, 1081 HV
- Recruiting
Research Site
Arnhem, 6815 AD
- Recruiting
Research Site
Leiden, 2333 ZA
Puerto Rico1 site, 1 recruiting
- Recruiting
Research Site
Rio Piedras, 00935
About this study
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)
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.
Read the 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.
- Being tested
- Rilvegostomig, Trastuzumab deruxtecan, Trastuzumab, Pembrolizumab, 5-fluorouracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilvegostomigDrug
Also called AZD2936
Q3W, intravenous infusion
Trastuzumab deruxtecanDrug
Also called T-DXd, DS-8201
Q3W, intravenous infusion
TrastuzumabDrug
Q3W, intravenous infusion
PembrolizumabDrug
Q3W, intravenous infusion
5-fluorouracilDrug
Also called 5-FU
Q3W, intravenous infusion
CapecitabineDrug
BID, oral administration
CisplatinDrug
Q3W, intravenous infusion
OxaliplatinDrug
Q3W, intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | T-DXd + Rilvegostomig + Fluoropyrimidine (Capecitabine OR 5-FU) Receives: Drug: Rilvegostomig; Drug: Trastuzumab deruxtecan; Drug: 5-fluorouracil; Drug: Capecitabine |
| Arm B | Active comparator | Pembrolizumab + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin) Receives: Drug: Trastuzumab; Drug: Pembrolizumab; Drug: 5-fluorouracil; Drug: Capecitabine; Drug: Cisplatin; Drug: Oxaliplatin |
| Arm C | Active comparator | Rilvegostomig + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin) Receives: Drug: Rilvegostomig; Drug: Trastuzumab; Drug: 5-fluorouracil; Drug: Capecitabine; Drug: Cisplatin; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause.
Measured: Up to approximately 6 years
Overall Survival (OS)
OS is defined as time from randomization until the date of death due to any cause.
Measured: Up to approximately 6 years
Secondary outcomes (13)
Objective Response Rate (ORR)
ORR according to RECIST v1.1. ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR).
Measured: Up to approximately 6 years
Duration of Response (DoR)
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.
Measured: Up to approximately 6 years
Proportion of all randomized participants alive and progression-free at 6 months (PFS6)
Proportion of all randomized participants alive and progression-free at 6 months calculated for progression.
Measured: Up to 6 months
Proportion of all randomized participants alive and progression-free at 12 months (PFS12)
Proportion of all randomized participants alive and progression-free at 12 months calculated for progression.
Measured: Up to 12 months
Time to second progression or death (PFS2)
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.
Measured: Up to approximately 6 years
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Occurrence of AEs and SAEs will be graded according to the revised NCI CTCAE v5.0.
Measured: Up to approximately 6 years
Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum
Concentration of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, fluoropyrimidine, and capecitabine in serum or plasma.
Measured: Up to approximately 6 years
Immunogenicity of rilvegostomig and T-DXd assessed by the presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd
Presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
Measured: Up to approximately 6 years
Increase in enteral feeding assistance and eating difficulties
Time to first-confirmed worsening of eating symptoms or initiation of feeding assistance among all participants, as randomized.
Measured: Up to approximately 6 years
Proportion of time on study intervention with high side-effect bother
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).
Measured: Up to approximately 6 years
Overall Survival at 12 months (OS12)
Proportion of all randomized participants alive at 12 months.
Measured: Up to 12 months
Overall Survival at 24 months (OS24)
Proportion of all randomized participants alive at 24 months.
Measured: Up to 24 months
Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum
PK parameters (peak and trough concentrations).
Measured: Up to approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Mar 2025
- Primary completion27 Apr 2029 (estimated)
- Study completion9 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Gastric CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764875
- Sponsor's protocol ID
- D702AC00001
- Other IDs
- 2024-512583-57-00
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.