NCT06021483招募中不适用
Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection (Lurbinectedin) in Patients With Metastatic Small Cell Lung Cancer (SCLC) in Real-World Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- ORR (Overall Response Rate)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Zepzelca™ inj. in real-world practice and to investigate important identified risks and gaps in information related to risk management plans.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who voluntarily provide written consent for personal information collection and utilization after receiving an explanation about the objective and methods of the study
- •Patients who have received or are scheduled to receive Zepzelca™ inj., according to domestic approval indications
- •Patients with metastatic SCLC who have failed first-line platinum-based chemotherapy
排除标准
- •Patients with no prior history of platinum-based anticancer chemotherapy for cancer treatment
- •Patients with a history of hypersensitivity reactions to this drug or its components
- •Pregnant, potentially pregnant, or lactating women
- •Patients currently participating in another clinical trial (drug or medical device) or planning to participate in another clinical trial during the study period (except for non-interventional clinical studies or cases where the clinical trial drug administration has ended and only follow-up is remaining)
- •Patients who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.
结局指标
主要结局
ORR (Overall Response Rate)
时间窗: 6 months after the start of administration
Percentage of subjects who reached complete remission (CR) and partial remission (PR)
次要结局
未报告次要终点
研究者
研究点 (1)
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