A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZG006, 5-fluorouracil, Calcium folinate and Irinotecan.
- Who it may be relevant to
- Registry conditions: Neuroendocrine Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma
Overview
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
- Biological ZG006
ZG006 will be administered as an intravenous (IV) infusion. - Drug 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.
Primary outcome measures
- Overall Survival（OS） [Time frame: up to approximately 4 years]
Secondary outcome measures (1)
- Progression-free Survival (PFS) (RECIST1.1) [Time frame: up to approximately 4 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
Identifiers
NCT: NCT07595913 · ZG006-009