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

NCT07595913 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: ZG006-009
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroendocrine Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival（OS）

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

  up to approximately 4 years

Secondary Outcomes (1)

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

  up to approximately 4 years

Study Arms (2)

Test Group

EXPERIMENTAL

ZG006 Q2W

Biological: ZG006

Control Group

ACTIVE COMPARATOR

Investigator-selected chemotherapy (such as FOLFIRI regimen)

Drug: 5-fluorouracil, Calcium folinate and Irinotecan

Interventions

ZG006 BIOLOGICAL

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

Test Group

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.

Also known as: FOLFIRI

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)..

You may not qualify if:

• Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

Fluorouracil; Leucovorin; Irinotecan; IFL protocol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Shangdi Ning

CONTACT

+86-0512-57309965; ningsd@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

CN (1)