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

StatusRecruiting
PhasePhase 3
Started2025-03-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status, Contacts/Locations v12
Trial sites expanded: 293 → 302 locations
2026-06-15
Study Status, Contacts/Locations v11
Trial sites expanded: 289 → 293 locations
2026-05-11
Study Status, Contacts/Locations v10
Trial sites expanded: 286 → 289 locations
2026-04-08
Study Status, Eligibility, Contacts/Locations v9
Study sites284→286
Eligibility criteria-36 characters
[...] on RECIST v1.1. Have adequate organ and bone marrow function within 14 days before randomization. LVEF ≥ 5550% within 28 days before randomization. Adequate treatment wa [...]
2026-03-06
Study Status, Contacts/Locations v8
Study sites279→284
Show 7 earlier versions
2026-01-30
Study Status, Contacts/Locations v7
Study sitesdetails revised at 15 of 279 sites
2025-12-09
Study Status, Contacts/Locations v6
Study sites277→279
2025-10-27
Study Status v5
Re-verified, no change to tracked fields
2025-09-11
Study Status, Contacts/Locations v4
Study sites265→277
2025-07-09
Study Status, Contacts/Locations v3
Primary completion date2029-04-02→2029-04-27
Completion date2030-11-12→2030-12-09
Study sites228→265
2025-04-25
Study Status, Contacts/Locations v2
Primary completion date2029-04-27→2029-04-02
Completion date2030-12-09→2030-11-12
Study sites205→228
2025-03-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03-28→confirmed 2025-03-01
Study sites150→205
2025-01-07
Original filing
AstraZeneca
725 trials monitored
See 68 trials at risk
Gastric Cancer
1,194 trials monitored
See 60 trials at risk
HER2-Positive Cancer
324 trials monitored
See 21 trials at risk
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.
Trial Details
NCT Number NCT06764875
Lead Sponsor AstraZeneca
Conditions HER2-positive Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Enrollment 840 participants
Start Date 2025-03-01
Primary Completion 2029-04-27 (estimated)
Study Completion 2030-12-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-11