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.
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)..
Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.
Parallel
ZG006
Biological/VaccineZG006 will be administered as an intravenous (IV) infusion.
5-fluorouracil, Calcium folinate and Irinotecan
DrugIrinotecan 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.
Overall Survival（OS）
Duration from the date of initial treatment to the date of death due to any cause.
Progression-free Survival (PFS) (RECIST1.1)
A duration from the date of initial treatment to disease progression or death of any cause.
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This trial is not recruiting at the moment. You can still explore other options:
