A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled
- Registration Number
- NCT06282991
- 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 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 I/II 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- Age ≥ 20 years old
- Patients who were approved to join Lorlatinib CUP on or before 31 Jul 2019 while initiate Lorlatinib treatment before 30 Sep 2019,
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Patient treated Lorlatinib other than CUP.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lorlatinib Lorlatinib Patients received lorlatinib treatment under EAP
- Primary Outcome Measures
Name Time Method The treatment pattern from initial diagnosis to current lorlatinib treatment. 1 year prior to lorlatinib treatment started To describe the treatment from initial diagnosis of NSCLC and the line setting of lorlatinib for their metastatic NSCLC with ALK or ROS1 rearrangement
- Secondary Outcome Measures
Name Time Method progression-free survival From first dose of lorlatinib until 30 Sep 2020, or first documented progression or date of death from any cause, whichever came first, assessed upto 30 months. duration (month) between first dose of lorlatinib and disease progression or death or end of study
objective response rate (ORR) From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months. Percentage of the best response recorded for each participants during lorlatinib treatment.
1-year OS rate from first dose of lorlatinib to 12 months later percentage of survival in first year
time-to-treatment failure for all NSCLC From first dose of lorlatinib until 30 Sep 2020 or death from any cause, whichever occurred first, assessed up to 30 months. duration of treatment of all NSCLC treatment captured from medical records
The clinical nature, incidence, duration, and severity of lorlatinib-related safety profile From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months. The clinical nature, incidence, duration, and severity of Lorlatinib related adverse drug reaction; outcome and possible causality will be recorded.
overall survival From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months. duration (month) between first dose of lorlatinib and death or end of study
time-to-treatment failure of lorlatinib From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months. duration (month) between lorlatinib start and disease progression by investigator's final assessment
Trial Locations
- Locations (6)
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch
🇨🇳Kaohsiung City, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
🇨🇳Taoyuan City, Taiwan