NCT07595913尚未招募3 期
A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Overall Survival（OS）
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)..
排除标准
- •Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.
研究组 & 干预措施
Control Group
Active Comparator
Investigator-selected chemotherapy (such as FOLFIRI regimen)
干预措施: 5-fluorouracil, Calcium folinate and Irinotecan (Drug)
Test Group
Experimental
ZG006 Q2W
干预措施: ZG006 (Biological)
结局指标
主要结局
Overall Survival（OS）
时间窗: up to approximately 4 years
Duration from the date of initial treatment to the date of death due to any cause.
次要结局
- Progression-free Survival (PFS) (RECIST1.1)(up to approximately 4 years)
研究者
研究点 (1)
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