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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
ZG006 will be administered as an intravenous (IV) infusion.
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.
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Overall Survival（OS）
Duration from the date of initial treatment to the date of death due to any cause.
Time frame: up to approximately 4 years
Progression-free Survival (PFS) (RECIST1.1)
A duration from the date of initial treatment to disease progression or death of any cause.
Time frame: up to approximately 4 years
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