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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (7 UK sites)
Research Site
Cambridge CB2 2QQ, United Kingdom
Research Site
Coventry CV2 2DX, United Kingdom
Research Site
Dundee DD1 9SY, United Kingdom
Research Site
London EC1A 7BE, United Kingdom
Research Site
London W1G 6AD, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
Research Site
Sutton SM2 5PT, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
