A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma

NCT07595913 · tracked via the Priya Life Science China tracker

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase

Phase 3

Started

2026-07

Last updated

2026-05-19

Condition(s) studied

Neuroendocrine Carcinoma

Investigational drug(s) / intervention(s)

ZG0065-fluorouracil, Calcium folinate and Irinotecan

ZG006: ZG006 will be administered as an intravenous (IV) infusion.

5-fluorouracil, Calcium folinate and Irinotecan: Irinotecan 180 mg/m\^2, Calcium folinate 400 mg/m\^2, 5-Fluorouracil: 400 mg/m\^2 by intravenous infusion on Day 1; 5-Fluorouracil: 2400 mg/m\^2 by continuous intravenous infusion over 46 to 48 hours， once two weeks.

Study summary

This Phase III, multicenter, randomized, open-label, controlled study is designed to assess the efficacy and safety of ZG006 versus investigator-selected chemotherapy in participants with DLL3-positive advanced neuroendocrine carcinoma who have received prior systemic therapy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Has provided written informed consent voluntarily after being fully informed about the study. * Male or female, aged 18 to 75 years (inclusive) at the time of informed consent signing. * Histologically or cytologically confirmed advanced neuroendocrine carcinoma (NEC); small cell lung cancer (SCLC) and combined SCLC are excluded. Additionally, the Participants with DLL3-positive NEC who have received prior systemic therapy (second-line and above).. Exclusion Criteria: * Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.

Primary outcome measure(s)

Overall Survival（OS） — up to approximately 4 years
Duration from the date of initial treatment to the date of death due to any cause.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

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ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular Starting soon

Other trials for the same condition

ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma Recruiting

Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma Recruiting

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A Single-arm, Open-label, Clinical Trial of Surufatinib/Serplulimab/Platinum/Etoposide in Neuroendocrine Carcinoma. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07595913 on ClinicalTrials.gov ↗ ← All trials in China