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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07595913

Enrollment

240

Registered

2026-05-19

Start date

2026-07-01

Completion date

2028-12-01

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Carcinoma

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.

Interventions

BIOLOGICALZG006

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

DRUG5-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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Progression-free Survival (PFS) (RECIST1.1)	up to approximately 4 years	A duration from the date of initial treatment to disease progression or death of any cause.

Countries

China

Contacts

CONTACTShangdi Ning

ningsd@zelgen.com+86-0512-57309965

STUDY_CHAIRJason Wu

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026