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NCT Number: NCT07595913

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

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.

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Key information

Conditions

Neuroendocrine Carcinoma Adenocarcinoma Carcinoma Carcinoma, Neuroendocrine Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location contact

Lijie Song

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZG006

Biological

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

5-fluorouracil, Calcium folinate and Irinotecan

Drug

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.

Other names: FOLFIRI

Primary outcomes

  1. Overall Survival（OS）

    Time frame: up to approximately 4 years

    Duration from the date of initial treatment to the date of death due to any cause.

Secondary outcomes

  1. Progression-free Survival (PFS) (RECIST1.1)

    Time frame: up to approximately 4 years

    A duration from the date of initial treatment to disease progression or death of any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Shangdi Ning

CONTACT

[email protected]

+86-0512-57309965

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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