NCT07833839尚未招募3 期
A Randomized, Double-Blind, Controlled, Multicenter Phase III Clinical Trial of ZG005 in Combination With Etoposide and Cisplatin Versus Etoposide and Cisplatin as First-Line Treatment for 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
- 440
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This is a randomized, double-blind, controlled, multicenter Phase III study evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of ZG005 combined with the EP regimen (etoposide plus cisplatin) in participants with advanced NEC who are naive to 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Participant has fully understood the trial, agrees to comply with the study treatment regimen and visit schedule, and voluntarily signs the informed consent form (ICF).
- •Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF).
- •Life expectancy of more than 3 months.
- •Histologically confirmed recurrent or metastatic neuroendocrine carcinoma (NEC).
- •The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
排除标准
- •History, computed tomography (CT), or magnetic resonance imaging (MRI) findings suggestive of central nervous system (CNS) metastases or leptomeningeal metastases.
研究组 & 干预措施
ZG005 + Etoposide + Cisplatin
Experimental
Treatment arm
干预措施: ZG005 for Injection (Drug)
ZG005 Placebo + Etoposide + Cisplatin
Active Comparator
Control arm
干预措施: ZG005 placebo for injection (Drug)
ZG005 Placebo + Etoposide + Cisplatin
Active Comparator
Control arm
干预措施: Cisplatin Injection (Drug)
ZG005 + Etoposide + Cisplatin
Experimental
Treatment arm
干预措施: Etoposide Injection (Drug)
ZG005 + Etoposide + Cisplatin
Experimental
Treatment arm
干预措施: Cisplatin Injection (Drug)
ZG005 Placebo + Etoposide + Cisplatin
Active Comparator
Control arm
干预措施: Etoposide Injection (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 48 months
次要结局
- Progression-free survival (PFS)(Up to 48 months)
- Objective Response Rate (ORR)(Up to 48 months)
- Duration of response (DoR)(Up to 48 months)
- Occurrence of adverse event (AE) and serious adverse event (SAE)(Up to 48 months)
研究者
研究点 (1)
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