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Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric/GEJ Adenocarcinoma

Study acronym: G/GEJ
StatusRecruiting
PhasePhase 3
SponsorAkeso
Started2026-09-24
View on ClinicalTrials.gov ↗

Amendment history

2026-09-30
notable
Recruitment opened
96 trials monitored
See 1 trial at risk
The goal of this randomized, double-blind, multi-regional phase 3 study of cadonilimab combined with chemotherapy versus chemotherapy in combination with or without nivolumab for the first-line treatment of participants with HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma trial is to compare OS between cadonilimab combined with chemotherapy and chemotherapy in combination with or without nivolumab in the ITT population.
Trial Details
NCT Number NCT07700979
Lead Sponsor Akeso
Conditions Gastric / Gastroesophageal Junction Adenocarcinoma
Enrollment 900 participants
Start Date 2026-09-24
Primary Completion 2029-08-18 (estimated)
Study Completion 2030-08-18 (estimated)
Updated on ClinicalTrials.gov 2026-09-29