Retrospective, Observational Study On The Efficacy And Safety Of Lorlatinib In ALK or ROS1 Metastatic Non-Small Cell Lung Cancer Patients Treated Within The Compassionate Use Program In Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 25
- 主要终点
- Progression-free survival
研究概览
简要总结
This is an observational, non-interventional, retrospective, multicentre and nationwide study. The information will be obtained retrospectively, in most cases when the treatment has already ended.
The primary objective of this study is determine the activity of lorlatinib (percentage of responses, duration of response, progression-free survival and time to treatment failure) of patients included in the compassionate use program in Spain.
详细描述
This is an observational, non-interventional, retrospective, multicentre and nationwide study. The information will be obtained retrospectively, in most cases when the treatment has already ended. In cases where the patient continues on the treatment, the researcher will not modify the clinical management of the patient by participating in the study.
Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration. According to the records of the Spanish centres participating in this program, approximately 145 patients have been included.
The primary objective of this study is determine the activity of lorlatinib (percentage of responses, duration of response, progression-free survival and time to treatment failure) of patients included in the compassionate use program in Spain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration.
- •Patients must have been treated with at least one cycle of lorlatinib within the compassionate use program.
- •Alive patients must have signed, dated the ethics committee approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.
排除标准
- •Alive patients who refuse to sign and date an ethics committee approved written informed consent form.
- •Patients who were accepted in the compassionate use program , but did not receive treatment.
研究组 & 干预措施
Experimental : Lorlatinib inn ALK Or ROS1 Metastatic NSCLC patient
Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration.
干预措施: Lorlatinib (Drug)
结局指标
主要结局
Progression-free survival
时间窗: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Progression-free survival defined as time from the first dose of lorlatinib to the first documentation of progression or death from any cause.
Duration of the response
时间窗: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Duration of the response defined from the first documentation of tumor response to the first documentation of tumor progression or death from any cause.
Time to treatment failure
时间窗: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Time to treatment failure defined as time from the first dose of lorlatinib to the moment of discontinuation of treatment for any cause, including tumor progression, toxicity or death
次要结局
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(From date of the first dose of lorlatinib treatment until the date of last follow up or death,assessed up to 60 months)
- Overall survival of ALK and ROS1 NSCLC patients(From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months)