NCT04087473已完成不适用
Plasma Molecular Profiling in ALK Inhibitor Resistant Non-Small Cell Lung Cancer
National Cancer Centre, Singapore10 个研究点 分布在 5 个国家目标入组 50 人开始时间: 2019年8月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Molecular profiling of plasma
研究概览
简要总结
The investigators plan to understand a comprehensive molecular profiling via the plasma, with the primary aim of using this form on analysis to guide subsequent treatment selection. This study will provide a better understanding of ALK resistance in the treatment of Asian lung cancers and allow for improved clinical outcomes by 'matching' the secondary mutations to an ALK inhibitor which would allow for the greatest coverage ultimately leading to lasting duration of response.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced ALK fusion oncogene positive lung adenocarcinoma that have progressed after 1-2 ALK inhibitors, with at least one prior line of 2nd generation ALKi (i.e. Ceritinib, Alectinib, Brigatinib or Ensartinib)
- •The availability of sufficient plasma
- •Age ≥ 21 years
- •WHO performance status ≤ 2
- •Life expectancy of ≥ 21 weeks
- •Patients should have adequate organ function for potential consideration into clinical trials (routine blood tests are valid within 14 days before enrollment):
- •Adequate bone marrow function as shown by: ANC ≥ 1.0x10^9/L, Platelets ≥ 75x10^9/L, Hb ≥ 7.5 g/dL
- •Alanine aminotransferase (ALT) and aspirate aminotransferase (AST) normal range (or ≤ 3.0xULN if liver metastases are present)
- •Willing to provide signed informed consent
- •Patients whom do not fulfill the above criteria may be discussed on a case-by-case basis within the study team, for potential enrolment
排除标准
- •Received more than 2 prior ALK inhibitors (ALKi)
- •Symptomatic or uncontrolled brain metastases requiring concurrent treatment inclusive but not limited to surgery and radiation. Stable/ tailing doses of corticosteroids is permitted
结局指标
主要结局
Molecular profiling of plasma
时间窗: 2 to 4 weeks after collection of plasma
Profiling of the collected plasma samples at a molecular level to evaluate the molecular epidemiology of ALK fusion oncogene positive lung cancer
次要结局
- Clinical outcomes of the subsequent treatments the patients receive(After molecular profiling has been completed, every few months up to 2 years)
- Patient survival status(After molecular profiling has been completed, every few months up to 2 years)
- Subsequent patient treatment status(After molecular profiling has been completed, every few months up to 2 years)
研究者
研究点 (10)
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