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Looking for participantsPhase3

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

Sponsor: AstraZeneca

NCT ID: NCT06764875

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Rilvegostomig (drug), Trastuzumab deruxtecan (drug), Trastuzumab (drug), Pembrolizumab (drug)
How long the study runs
Study runs about 69 months (dates as stated)
About the drug or intervention
Rilvegostomig — drug: Q3W, intravenous infusion · Trastuzumab deruxtecan — drug: Q3W, intravenous infusion · Trastuzumab — drug: Q3W, intravenous infusion · Pembrolizumab — drug: Q3W, intravenous infusion · 5-fluorouracil — drug: Q3W, intravenous infusion · Capecitabine — drug: BID, oral administration · Cisplatin — drug: Q3W, intravenous infusion · Oxaliplatin — drug: Q3W, intravenous infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
840
Started
2025-03-01
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for her2-positive gastric cancer
  • • Phase3 - 840 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with her2-positive gastric cancer

Where?

  • • Cambridge - Research Site
  • • Coventry - Research Site
  • • Dundee - Research Site
  • • London - Research Site
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

HER2-positive Gastric CancerGastroesophageal Junction Adenocarcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2HER2 positivePD-L1combined positive

What the study is looking for

  • ✓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, that has grown locally or that has spread gastric or GEJ adenocarcinoma.
  • ✓WHO or activity scale performance status of 0 or 1.

Who cannot take part

  • ✗Lack of physiological integrity of the upper gastrointestinal tract.
  • ✗Known dihydropyrimidine dehydrogenase enzyme deficiency.
  • ✗safety concern to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or...
  • ✗Persistent toxicities caused by previous anti-cancer therapy.
  • ✗Uncontrolled infection including tuberculosis and active hepatitis A infection.
See the full criteria
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.

Where Is This Study? (7 UK sites)

Research Site

Cambridge CB2 2QQ, United Kingdom

Recruiting

Research Site

Coventry CV2 2DX, United Kingdom

Recruiting

Research Site

Dundee DD1 9SY, United Kingdom

Recruiting

Research Site

London EC1A 7BE, United Kingdom

Recruiting

Research Site

London W1G 6AD, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

Research Site

Sutton SM2 5PT, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09