Real-world Effectiveness and Treatment Sequences in Patients With Extensive Stage SCLC Who Received Lurbinectedin as Part of the French Early Access Program (ATU).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- demographic and clinical characteristics of patients
研究概览
简要总结
LURBICLIN cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of ATU program. LURBICLIN will evaluate effectiveness and safety of lurbinectedin in real-world conditions.
详细描述
LURBICLIN cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of ATU program. LURBICLIN will evaluate overall survival, real world progression-free survival, best response and duration of treatment in patients with advanced, metastatic Small Cell Lung Cancer (SCLC) who received lurbinectedin as part of the French Early Access Program (ATU). Previous and subsequent treatments (treatment delivered immediately after treatment with lurbinectedin) will be recorded. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer
- •Patients who were informed about the study and accepted for their data to be collected
- •Patients who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program).
- •Selection period spans from June 2020 until March 2021 for initiation of treatment with lurbinectedin.
排除标准
- •Patients enrolled in a clinical trial assessing treatment with lurbinectedin
结局指标
主要结局
demographic and clinical characteristics of patients
时间窗: 8 months
prior therapy
次要结局
- Overall Survival (OS)(8 months)
- Adverse Drug Reaction(8 months)
- Real-world progression-free survival(8 months)
- Pattern of tumor progression(8 months)
- Duration of treatment with lurbinectedin beyond progression(8 months)
- Best response(8 months)
- Duration of treatment(8 months)