A RETROSPECTIVE STUDY TO EVALUATE THE REAL-WORLD EFFECTIVENESS OF LORLATINIB AMONG ROS1-POSITIVE NSCLC PATIENTS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- real-world progression-free survival
研究概览
简要总结
The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled.
This study is seeking participants who:
- have lung cancer that could not be controlled.
- have a type of gene called a ROS proto-oncogene 1. A gene is a part of your DNA that has instructions for making things your body needs to work.
- have received at least 1 treatment before.
All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take lorlatinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 are aged 18 years or older on index date
- •Patients have confirmed diagnosis of ROS1-positive NSCLC
- •Patients have received at least one dose of lorlatinib between 1st April, 2018, and 30th September, 2023
排除标准
- •1. Patients participated in any clinical trials using lorlatinib during the observation period.
研究组 & 干预措施
Lorlatinib
Patients with ROS1(+) advanced/metastatic NSCLC had been treated with lorlatinib.
干预措施: Lorlatinib (Drug)
结局指标
主要结局
real-world progression-free survival
时间窗: 74 months from 1st April, 2018
Time to real-world disease progression or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib.
The overall survival (OS)
时间窗: 74 months from 1st April, 2018
Time to death during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib.
The real world time to next treatment (rwTTNT)
时间窗: 74 months from 1st April, 2018
Time to subsequent treatment or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib.
The real world intracranial progression free survival (rwICPFS)
时间窗: 74 months from 1st April, 2018
Time to real-world intracranial disease progression or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib.
次要结局
- Number and proportion of patients receiving each regimen of systemic anti-cancer therapy(74 months from 1st April, 2018)
- Mean (SD), median (interquartile range, IQR), minimum and maximum value of duration of therapy (DoT) of lorlatinib(74 months from 1st April, 2018)
- Number and proportion of patients receiving concomitant antihyperlipidemic agents(74 months from index date; index date is the date of the first dose of lorlatinib)