NCT07189455招募中3 期
A Multicenter, Randomized, Controlled, Open-Label Phase III Study Evaluating the Efficacy and Safety of ZG006 for Injection Compared With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS).
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
- •Fully understand the study and voluntarily sign the informed consent form;
- •Male or female 18~75 years of age;
- •Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
- •Life expectancy ≥ 3 months;
- •Histologically or cytologically confirmed Small Cell Lung Cancer.
排除标准
- •Participants were deemed unsuitable for participating in the study by the investigator for any reason.
研究组 & 干预措施
ZG006
Experimental
ZG006 10 mg Q2W
干预措施: ZG006 (Drug)
Investigator-Selected Chemotherapy
Active Comparator
Investigator-selected chemotherapy, such as topotecan.
干预措施: Topotecan (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 3 years
次要结局
- Serum Concentrations of ZG006(Up to approximately 3 years)
- Number of participants with adverse events (AEs)(Up to approximately 3 years)
研究者
研究点 (1)
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