Carcinoma, Non-Small-Cell Lung
Conditions
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.
Interventions
DRUGLorlatinib
Lorlatinib is an ALK/ROS1 tyrosin kinase inhibitor.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients are aged 18 years or older on index date 2. Patients have confirmed diagnosis of ROS1-positive NSCLC 3. Patients have received at least one dose of lorlatinib between 1st April, 2018, and 30th September, 2023
Exclusion criteria
1\. Patients participated in any clinical trials using lorlatinib during the observation period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed