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NCT06764875 · ClinicalTrials.gov registry record · Phase 3
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 of Gastroesophageal Junction Adenocarcinoma and HER2-positive Gastric Cancer, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 840
- Enrollment target
- 20
- Study locations
NCT06764875: Recruiting Phase 3 study of Gastroesophageal Junction Adenocarcinoma and HER2-positive Gastric Cancer, sponsored by AstraZeneca.
NCT06764875 is a Phase 3 study of Gastroesophageal Junction Adenocarcinoma and HER2-positive Gastric Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 840 participants, above the 383-participant average among 40 other Gastroesophageal Junction Adenocarcinoma trials with a reported enrollment target (119% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06764875, a Phase 3 study of Gastroesophageal Junction Adenocarcinoma and HER2-positive Gastric Cancer, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 840 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Trastuzumab
- DRUG Trastuzumab deruxtecan
- DRUG Rilvegostomig
- DRUG 5-fluorouracil
Study Locations (20)
California
- Research Site - Duarte
- Research Site - La Jolla
- Research Site - Los Alamitos
- Research Site - Los Angeles
- Research Site - Santa Monica
- Research Site - Solvang
- Research Site - Upland
- Research Site - Walnut Creek
Illinois
- Research Site - Chicago
- Research Site - Chicago
- Research Site - Evanston
- Research Site - Hinsdale
- Research Site - Niles
Florida
- Research Site - Jacksonville
- Research Site - Orlando
Alaska
- Research Site - Anchorage
Arizona
- Research Site - Phoenix
Colorado
- Research Site - Aurora
Georgia
- Research Site - Marietta
Indiana
- Research Site - Dyer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 840 participants |
| Start Date | 2025-03-01 |
| Est. Completion | 2030-12-09 |
| Phase | Phase 3 |
What NCT06764875 shows while recruiting
NCT06764875 is an interventional study that assigns participants to a tested intervention. The registered 840 participants enrollment target is mid-sized for trials with a published cap, above the 383-participant average among 40 other Gastroesophageal Junction Adenocarcinoma trials with a reported enrollment target (119% higher).
The record links to 2 conditions, with Gastroesophageal Junction Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06764875 names 20 study sites across 8 states, led by California, Illinois, Florida.
Frequently Asked Questions
What is clinical trial NCT06764875 about?
NCT06764875 is a clinical study titled "A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer". 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...
What is the current status of trial NCT06764875?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 840 participants. The study started on 2025-03-01. Estimated completion is 2030-12-09.
What conditions does trial NCT06764875 study?
This clinical trial studies the following conditions: Gastroesophageal Junction Adenocarcinoma, HER2-positive Gastric Cancer.
What interventions are being tested in trial NCT06764875?
The interventions under investigation include: Pembrolizumab (DRUG), Trastuzumab (DRUG), Trastuzumab deruxtecan (DRUG), Rilvegostomig (DRUG), 5-fluorouracil (DRUG).
Who is sponsoring clinical trial NCT06764875?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06764875 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06764875's enrollment target sits among peer trials
840 8th of 40 higher than 33 of 40 other Gastroesophageal Junction Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Junction Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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