NCT07473128招募中3 期
A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage 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
- 120
- 试验地点
- 1
- 主要终点
- To Compare trilaciclib to placebo on prevention of myelosuppression
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy and safety of trilaciclib versus placebo in subjects with limited stage small cell lung cancer. The main question it aims to answer is:
Does trilaciclib have a myeloprotective effect in subject with limited stage small cell lung cancer?
Participants will be randomised to receive either trilaciclib or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Confirmed diagnosis of Limited-Stage Small Cell Lung Cancer
- •Complete recovery from prior anti-tumor surgical procedures
- •Measurable and evaluable disease through tumor assessment
- •Willingness to participate and sign informed consent form
排除标准
- •Extensive Stage Small Cell Lung Cancer
- •Active cardiovascular disease
- •Known hypersensitivity to trilaciclib, etoposide, carboplatin, cisplatin or any component in their formulations
- •Pregnant or nursing women
研究组 & 干预措施
Trilaciclib
Experimental
Receives trilaciclib
干预措施: Trilaciclib (Drug)
Placebo
Placebo Comparator
Receives placebo
干预措施: Saline (0.9% NaCl) (Drug)
结局指标
主要结局
To Compare trilaciclib to placebo on prevention of myelosuppression
时间窗: From enrollment and 4 months after
Duration and occurrence of severe neutropenia
次要结局
- Number of all-cause chemotherapy dose reductions(From enrollment and 4 months after)
- Occurrence of granulocyte colony-stimulating factor (G-CSF) administration(From enrollment and 4 months after)
- Number of hospitalizations due to myelosuppression or sepsis(From enrollment and 4 months after)
- Number of febrile neutropenia(From enrollment and 4 months after)
- Occurrence of red blood cell (RBC) transfusions(From enrollment and 4 months after)
研究者
研究点 (1)
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