A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled

Non-Small Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06282991
• Other study ID #: B7461028
• Status: Completed
• Start date: July 22, 2020
• Est. completion date: January 18, 2021

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 18, 2021
• Est. primary completion date: January 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patient treated Lorlatinib other than CUP.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Carcinoma

Intervention

Drug:
• Lorlatinib
ALK/ROS1 tyrosine kinase inhibitor

Locations

Country	Name	City	State
Taiwan	CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch	Kaohsiung City
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital - Linkou Branch	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The treatment pattern from initial diagnosis to current lorlatinib treatment.	To describe the treatment from initial diagnosis of NSCLC and the line setting of lorlatinib for their metastatic NSCLC with ALK or ROS1 rearrangement	1 year prior to lorlatinib treatment started
Secondary	objective response rate (ORR)	Percentage of the best response recorded for each participants during lorlatinib treatment.	From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months.
Secondary	overall survival	duration (month) between first dose of lorlatinib and death or end of study	From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months.
Secondary	progression-free survival	duration (month) between first dose of lorlatinib and disease progression or death or end of study	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.
Secondary	1-year OS rate	percentage of survival in first year	from first dose of lorlatinib to 12 months later
Secondary	time-to-treatment failure for all NSCLC	duration of treatment of all NSCLC treatment captured from medical records	From first dose of lorlatinib until 30 Sep 2020 or death from any cause, whichever occurred first, assessed up to 30 months.
Secondary	time-to-treatment failure of lorlatinib	duration (month) between lorlatinib start and disease progression by investigator's final assessment	From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months.
Secondary	The clinical nature, incidence, duration, and severity of lorlatinib-related safety profile	The clinical nature, incidence, duration, and severity of Lorlatinib related adverse drug reaction; outcome and possible causality will be recorded.	From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months.

External Links

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