Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06282991
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2024-02-01
Brief Title:
A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Lorlatinib in Patients With Advanced Non-Small Cell Lung Cancer Who Progress on First- and Second- Generation Tyrosine Kinase Inhibitor A Real-world Evidence Among Taiwanese Population Non-Interventional Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 anaplastic lymphoma kinase 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 dacomitinib 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
This study is seeking participants who
have lung cancer that could not be controlled
have a type of gene called anaplastic lymphoma kinase 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 dacomitinib 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:
Non-small cell lung cancer NSCLC 80-85 of all lung cancers remains the most common cause of cancer-related mortality globally most often diagnosed in advanced stages Targeted drugs are currently the most often used therapies for advanced NSCLC patients that harbor molecular alterations including the echinoderm microtubule-associated protein like 4 EML4-anaplastic lymphoma kinase ALK translocation For ALK-positive NSCLC patients crizotinib ceritinib alectinib and brigatinib are the first- and second-generation tyrosine kinase inhibitors TKIs Although the benefit of them has been demonstrated in series of pivotal clinical trials most patients who initially derive the benefit latterly develop resistance due to secondary mutations Lorlatinib a third-generation inhibitor is a TKI of ALK and Receptor Tyrosine Kinase C-Ros Oncogene I ROS-1 It is also a potent TKI that is effectively against known resistant mutants that mediate resistance to first- and second-generation ALK-TKIs Despite the efficacy and safety data derived from the pivotal phase III clinical trial there are limited data describing the use of lorlatinib and its outcomes in real-world practice settings outside the highly controlled environs of clinical trials The objective of this study is therefore to evaluate real-world systemic treatment patterns clinical outcome therapeutic effect safety profile of Lorlatinib in advanced NSCLC patients and also factors associated with clinical outcome in those Lorlatinib treated patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None