A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer (NSCLC) Which Has Spread Out.
- Registration Number
- NCT06678555
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1
- 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
- Patients participated in any clinical trials using lorlatinib during the observation period.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lorlatinib Lorlatinib Patients with ROS1(+) advanced/metastatic NSCLC had been treated with lorlatinib.
- Primary Outcome Measures
Name Time Method real-world progression-free survival 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) 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) 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) 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.
- Secondary Outcome Measures
Name Time Method Number and proportion of patients receiving each regimen of systemic anti-cancer therapy 74 months from 1st April, 2018 The percentage of patients with each systemic anticancer therapy for lung cancer.
Mean (SD), median (interquartile range, IQR), minimum and maximum value of duration of therapy (DoT) of lorlatinib 74 months from 1st April, 2018 Time to real-world discontinuation of lorlatinib 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.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 The number and percentage of patients receiving antihyperlipidemic agents received along with lorlatinib during the same treatment period
Trial Locations
- Locations (1)
Pfizer
🇨🇳Taipei, Taiwan