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ZG005 Plus Etoposide and Cisplatin vs. Etoposide and Cisplatin as First-Line Treatment for Advanced Neuroendocrine Carcinoma
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Summary
This is a randomized, double-blind, controlled, multicenter Phase III study evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of ZG005 combined with the EP regimen (etoposide plus cisplatin) in participants with advanced NEC who are naive to systemic therapy.
Official title: A Randomized, Double-Blind, Controlled, Multicenter Phase III Clinical Trial of ZG005 in Combination With Etoposide and Cisplatin Versus Etoposide and Cisplatin as First-Line Treatment for Advanced Neuroendocrine Carcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2026-10
Completion Date
2031-12
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
ZG005 for Injection
Intravenous infusion
Etoposide Injection
Intravenous infusion
Cisplatin Injection
Intravenous infusion
ZG005 placebo for injection
Intravenous infusion
Locations (1)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China