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NOT YET RECRUITING
NCT07833839
PHASE3

ZG005 Plus Etoposide and Cisplatin vs. Etoposide and Cisplatin as First-Line Treatment for Advanced Neuroendocrine Carcinoma

Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

ZG005 for Injection

Intravenous infusion

DRUG

Etoposide Injection

Intravenous infusion

DRUG

Cisplatin Injection

Intravenous infusion

DRUG

ZG005 placebo for injection

Intravenous infusion

Locations (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China