New hope for stomach cancer: phase 3 trial tests rilvegostomig combo

NCT ID NCT06764875

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This Phase 3 trial is testing whether a new drug called rilvegostomig, combined with trastuzumab deruxtecan and chemotherapy, works better than the current standard treatment for HER2-positive stomach cancer that has spread. About 840 people whose tumors have a specific protein (PD-L1 CPS ≥ 1) will be randomly assigned to one of three treatment groups. The study aims to see if the new combo helps people live longer or keeps their cancer from growing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: rilvegostomig (AZD2936) combined with trastuzumab deruxtecan (T-DXd) and chemotherapy
What this could lead to: If successful, this could offer a new first-line treatment option for people with HER2-positive gastric cancer, potentially improving how long they live without their cancer growing.
What could go wrong: This is a large Phase 3 trial, but it is still experimental. The new drug combination may not work better than current treatments, and side effects from the multiple drugs could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 840 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. HER2 positive for gastric cancer on a tumor biopsy. 2. PD-L1 combined positive score (CPS) ≥ 1. 3. Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing. 4. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma. 5. WHO or Eastern Cooperative Oncology Group performance status of 0 or 1. 6. Have measurable target disease assessed by the Investigator based on RECIST v1.1. 7. Have adequate organ and bone marrow function. 8. LVEF ≥ 50% within 28 days before randomization. 9. Adequate treatment washout period before randomization. Exclusion Criteria: 1. Lack of physiological integrity of the upper gastrointestinal tract. 2. Known dihydropyrimidine dehydrogenase enzyme deficiency. 3. Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label. 4. 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. 5. Persistent toxicities caused by previous anti-cancer therapy. 6. 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. 7. Uncontrolled infection including tuberculosis and active hepatitis A infection. 8. Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals. 9. Recent receipt of live, attenuated vaccine. 10. Chronic/active HBV or HCV infection unless controlled. 11. Clinically significant cardiac or psychological conditions. 12. Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. 13. History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. 14. Lung-specific intercurrent clinically significant illnesses. 15. Any active non-infectious skin disease requiring systemic treatment. 16. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART). 17. History of any of the following: drug-induced severe cutaneous adverse reaction. 18. Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors. 19. 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. 20. Current or prior use of immunosuppressive medication within 14 days before study intervention.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroesophageal junction adenocarcinoma HER2-positive gastric cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

272 sites in 28 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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Anchorage, Alaska, 99508, United States
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Phoenix, Arizona, 85054, United States
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Duarte, California, 91010, United States
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La Jolla, California, 92037, United States
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Los Alamitos, California, 90720, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90089, United States
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Santa Monica, California, 90404, United States
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Solvang, California, 93463, United States
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Upland, California, 91786, United States
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Walnut Creek, California, 94598, United States
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Aurora, Colorado, 80045, United States
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Newark, Delaware, 19713, United States
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Jacksonville, Florida, 32207, United States
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Jacksonville, Florida, 32224, United States
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Orlando, Florida, 32806, United States
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Athens, Georgia, 30607, United States
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Marietta, Georgia, 30060, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Evanston, Illinois, 60201, United States
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Hinsdale, Illinois, 60521, United States
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Niles, Illinois, 60714, United States
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Dyer, Indiana, 46311, United States
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Waukee, Iowa, 50263, United States
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Lexington, Kentucky, 40536, United States
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Louisville, Kentucky, 40217, United States
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Silver Spring, Maryland, 20904, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02118, United States
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Worcester, Massachusetts, 01655, United States
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Detroit, Michigan, 48202, United States
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Grand Rapids, Michigan, 49503, United States
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Burnsville, Minnesota, 55337, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63108, United States
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Omaha, Nebraska, 68198-5885, United States
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Reno, Nevada, 89502, United States
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Summit, New Jersey, 07901, United States
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Santa Fe, New Mexico, 87505, United States
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Albany, New York, 12206, United States
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Clifton Park, New York, 12065, United States
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New Hyde Park, New York, 11042, United States
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New York, New York, 10021, United States
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Cincinnati, Ohio, 45220, United States
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Columbus, Ohio, 43221, United States
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Oklahoma City, Oklahoma, 73104, United States
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Lancaster, Pennsylvania, 17601, United States
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Knoxville, Tennessee, 37909, United States
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Nashville, Tennessee, 37232, United States
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Dallas, Texas, 75246, United States
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Round Rock, Texas, 78665, United States
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Webster, Texas, 77598, United States
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Charlottesville, Virginia, 22908, United States
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Fairfax, Virginia, 22031, United States
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Fairfax, Virginia, 22031, United States
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Richmond, Virginia, 23235, United States
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Charleston, West Virginia, 25304, United States
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Madison, Wisconsin, 53792, United States
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Buenos Aires, 1264, Argentina
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Ciudad Autónoma Buenos Aires, C1430EFA, Argentina
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Ciudad de Buenos Aires, 1280, Argentina
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Rosario, 2123, Argentina
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Rosario, S2000DEJ, Argentina
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Viedma, R8500ACE, Argentina
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Darlinghurst, 2010, Australia
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Heidelberg, 3084, Australia
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Murdoch, 6150, Australia
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Westmead, 2145, Australia
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Linz, 4010, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Wiener Neustadt, 2700, Austria
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Barretos, 14784-057, Brazil
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Brasília, 71681-603, Brazil
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Campo Grande, 79020-180, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 91350-200, Brazil
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Recife, 50040-000, Brazil
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Salvador, 40170-110, Brazil
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São Paulo, 05652-9000, Brazil
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Vitória, 29043-272, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Brampton, Ontario, L6R 3J9, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Lévis, Quebec, G6V 3Z1, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Port Montt, 5480000, Chile
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Rancagua, 2852424, Chile
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Santiago, 7500653, Chile
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Santiago, 7620002, Chile
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Santiago, 8241479, Chile
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Temuco, 4810218, Chile
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Viña del Mar, 2520598, Chile
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Anyang, 455000, China
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Beijing, 100050, China
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Beijing, CN-100730, China
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Bengbu, 233004, China
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Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Fuzhou, 350001, China
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Fuzhou, 350014, China
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Guangzhou, 510060, China
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Guangzhou, 510655, China
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Guangzhou, 510700, China
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Hangzhou, 310016, China
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Harbin, 150081, China
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Hefei, 230022, China
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Hefei, 230031, China
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Jinan, 250021, China
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Kunming, 650118, China
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Lanzhou, 730000, China
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Linfen, 041099, China
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Linyi, 276001, China
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Nanchang, 330008, China
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Nanjing, 210009, China
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Nanjing, 210029, China
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Shandong, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shanghai, 201114, China
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Shenyang, 110004, China
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Shenyang, 110042, China
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Shijiazhuang, 050000, China
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Tianjin, 300060, China
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Wenzhou, 325000, China
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Wuhan, 430030, China
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Xi'an, 710061, China
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Xi'an, 710068, China
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Xining, 810001, China
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Yinchuan, 750004, China
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Zhengzhou, 450008, China
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Bordeaux, 33076, France
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Caen, 14000, France
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Clermont-Ferrand, 63003, France
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Dijon, 21079, France
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Lyon, 69373, France
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Marseille, 13273, France
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Poitiers, 86021, France
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Rennes, 35000, France
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Toulouse, 31059, France
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Villejuif, 94805, France
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Augsburg, 86156, Germany
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Bad Saarow, 15526, Germany
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Berlin, 10249, Germany
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Berlin, 10707, Germany
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Berlin, 13353, Germany
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Braunschweig, 38114, Germany
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Chemnitz, 9116, Germany
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Düsseldorf, 40225, Germany
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Erlangen, 91054, Germany
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Essen, 45122, Germany
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Frankfurt, 60488, Germany
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Göttingen, 37075, Germany
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Hamburg, 20246, Germany
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Leipzig, 04103, Germany
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Ludwigshafen, 67063, Germany
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Lübeck, 23538, Germany
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Mainz, 55131, Germany
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Mannheim, 68167, Germany
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Regensburg, 93053, Germany
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Tübingen, 72076, Germany
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Ulm, 89081, Germany
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Hong Kong, 150001, Hong Kong
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Hong Kong, 999077, Hong Kong
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Hong Kong, Hong Kong
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Budapest, 1083, Hungary
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Gyöngyös, 3200, Hungary
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Győr, 9024, Hungary
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Gyula, 5700, Hungary
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Zalaegerszeg, 8900, Hungary
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Ansārinagar, 110 029, India
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Bangalore, 560027, India
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NOT_YET_RECRUITING

Delhi, 110029, India
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Delhi, 110085, India
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Hyderabad, 500034, India
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Kolkata, 700094, India
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Mumbai, 400012, India
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NOT_YET_RECRUITING

Varanasi, 221005, India
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Cagliari, 09124, Italy
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Florence, 50134, Italy
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Milan, 20162, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Rozzano, 20089, Italy
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Torino, 10126, Italy
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Tricase, 73039, Italy
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Akashi-shi, 673-8558, Japan
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Bunkyō City, 113-8677, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 811-1395, Japan
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Fukuoka, 812-8582, Japan
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Hidaka-shi, 350-1298, Japan
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Hirakata-shi, 573-1191, Japan
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Hiroshima, 730-8518, Japan
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Kasama-shi, 309-1793, Japan
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Kita-gun, 761-0793, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Matsuyama, 791-0280, Japan
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Niigata, 951-8566, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
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Ota-shi, 373-8550, Japan
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Sakaishi, 591-8025, Japan
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Sendai, 980-8574, Japan
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Shiwa-gun, 028-3695, Japan
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Suita-shi, 565-0871, Japan
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Sunto-gun, 411-8777, Japan
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Toyoake-shi, 470-1192, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 241-8515, Japan
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George Town, 10450, Malaysia
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Ipoh, 30450, Malaysia
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Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Sabak Bernam, 88996, Malaysia
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Amsterdam, 1081 HV, Netherlands
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Arnhem, 6815 AD, Netherlands
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Leiden, 2333 ZA, Netherlands
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Arequipa, AREQUIPA54, Peru
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Callao, CALLAO 02, Peru
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Lima, 15036, Peru
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Lima, LIMA 29, Peru
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Lima, Lima 34, Peru
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Lima, Lima39, Peru
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San Isidro, 15073, Peru
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Bialystok, 15-027, Poland
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Gdansk, 80-219, Poland
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Koszalin, 75-581, Poland
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Lodz, 93-513, Poland
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Olsztyn, 10-228, Poland
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Przemyśl, 37-700, Poland
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Warsaw, 02-034, Poland
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Wroclaw, 50-556, Poland
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Rio Piedras, 00935, Puerto Rico
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Daegu, 41404, South Korea
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Goyang-si, 410-769, South Korea
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Gyeonggi-do, 13620, South Korea
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Jeonnam, 519-763, South Korea
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Seoul, 03080, South Korea
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Seoul, 03181, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 5505, South Korea
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Badalona, 08916, Spain
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Barcelona, 08035, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Ourense, 32005, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Valencia, 46010, Spain
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 824, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Tainan, 736, Taiwan
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Taipei, 100, Taiwan
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Taipei, 112, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Banphaeo, 74120, Thailand
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Dusit, 10300, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 22000, Thailand
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Ankara, 06100, Turkey (Türkiye)
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Antalya, 07100, Turkey (Türkiye)
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Diyarbakır, 21280, Turkey (Türkiye)
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Erzurum, 25240, Turkey (Türkiye)
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Istanbul, 34010, Turkey (Türkiye)
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Izmir, 35965, Turkey (Türkiye)
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Mezitli, 33200, Turkey (Türkiye)
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Cambridge, CB2 2QQ, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, W1G 6AD, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Sutton, SM2 5PT, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 70 449, Vietnam
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NOT_YET_RECRUITING

Ho Chi Minh City, 700000, Vietnam
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Hồ Chí Minh, 700000, Vietnam
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Viet Tri, 35000, Vietnam
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Vinh, 460000, Vietnam

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