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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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)..

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ZG006
  • 5-fluorouracil, Calcium folinate and Irinotecan

Treatment groups

240 Participants
are divided into 2 treatment groups