NCT06764875 A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
| NCT ID | NCT06764875 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AstraZeneca |
| Condition | HER2-positive Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 840 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2029-04-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 840 participants in total. It began in 2025-03-01 with a primary completion date of 2029-04-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06764875 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HER2-positive Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06764875 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 840 participants.
Is NCT06764875 currently recruiting?
Yes, NCT06764875 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06764875 trial being conducted?
This trial is being conducted at Anchorage, United States, Phoenix, United States, Duarte, United States, Glendale, United States and 11 additional locations.
Who is sponsoring the NCT06764875 clinical trial?
NCT06764875 is sponsored by AstraZeneca. The trial plans to enroll 840 participants.
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