NCT06758700招募中2 期
Phase II Clinical Study to Evaluate the Efficacy and Safety of Teniposide as a Post-Line Therapy for c-Myc-Driven Extensive-Stage Small Cell Lung Cancer
Shanghai Pulmonary Hospital, Shanghai, China1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年2月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The study is being conducted to investigate the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer who have failed standard treatment and with high expression of the c-Myc-driven FBXW2/MYC gene. Based on the results, the study will explore the correlation between the expression of FBXW2/MYC and the efficacy of teniposide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •extensive stage small cell lung cancer
- •Progression after receiving at least one chemotherapy drug treatment in the past;
- •ECOG score 0-1
- •c-Myc-driven
- •Expected survival period ≥3 months
- •Age: 18-75 years old;
- •The informed consent form complies with the ICH-GCP principles.
排除标准
- •No measurable lesions
- •Other severe and persistent diseases or organ system dysfunction;
- •Women planning pregnancy or men planning family planning;
- •Women who are pregnant or breastfeeding;
- •Those who cannot follow the research protocol provided by the investigator.
研究组 & 干预措施
Teniposide group
Other
Teniposide administration
干预措施: Teniposide administration (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, through study completion, an average of 1 year
次要结局
- Disease Control Rate(Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, through study completion, an average of 1 year)
- Progression Free Survial(Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, until progression or death, an average of 1 year)
- Adverse events(AEs), serious adverse events（SAEs）as assessed by CTCAE v5.0(From Baseline up to 30 days after the last dose)
- Duration of Response(Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, until progression or death, an average of 1 year)
研究者
Ren Shengxiang
Prof.
Shanghai Pulmonary Hospital, Shanghai, China
研究点 (1)
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