drugset / Trial / NCT07700979

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

NCT07700979

Phase 3 Not yet recruiting 900 enrolled Akeso
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2026-08-20
Primary completion
2029-08-18
Completion
2030-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Cadonilimab Monoclonal antibody
Comparator Nivolumab Monoclonal antibody
Background Capecitabine Small molecule
Background Oxaliplatin Small molecule