Clinical trial NCT06282991: A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Carcinoma
Keywords: ALK
TKI
Lorlatinib
RWE
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects will be enrolled from Lorlatinib Compassionate Use Program (CUP) and should be entered into this observational study at the physician's discretion.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The treatment pattern from initial diagnosis to current lorlatinib treatment.
timeFrame: 1 year prior to lorlatinib treatment started
Secondary outcomes:
measure: objective response rate (ORR)
timeFrame: From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months.
measure: overall survival
timeFrame: From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months.
measure: progression-free survival
timeFrame: 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.
measure: 1-year OS rate
timeFrame: from first dose of lorlatinib to 12 months later
measure: time-to-treatment failure for all NSCLC
timeFrame: From first dose of lorlatinib until 30 Sep 2020 or death from any cause, whichever occurred first, assessed up to 30 months.
measure: time-to-treatment failure of lorlatinib
timeFrame: From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months.
measure: The clinical nature, incidence, duration, and severity of lorlatinib-related safety profile
timeFrame: From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months.
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou Branch
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: