NCT04291937Approved For Marketing不适用
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin (PM01183) in Previously Treated Small Cell Lung Cancer in the USA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
研究概览
简要总结
This is an expanded access program in the USA to enable eligible patients with previously treated small cell lung cancer to access lurbinectedin treatment prior to FDA approval. Sites must apply to participate in the program. A medical doctor must assess whether the potential benefit outweighs the risk of the investigational therapy considering the program eligibility criteria and the individual patient's medical history.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Legally competent adult
- •Confirmed and unresectable Small Cell Lung Cancer (SCLC)
- •Patients must have received one prior chemotherapy containing line
- •Adequate organ, hematological, kidney, metabolic and liver function
- •Recovery from toxicities related to previous treatment(s)
- •Pregnancy must be excluded, medically acceptable contraception method
排除标准
- •Prior treatment with lurbinectedin
- •Certain concomitant diseases/conditions
- •Symptomatic, steroid-requiring or progressive CNS involvement.
- •Pregnant or breast-feeding women.
研究者
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