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

February 17, 2026 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Chang Gung Memorial Hospital Kaohsiung Branch
      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital
      • Taichung, Taiwan, 407219
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital - Linkou Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Lorlatinib
Patients received lorlatinib treatment under EAP
Drug: Lorlatinib
ALK/ROS1 tyrosine kinase inhibitor
Other Names:
  • PF-6463992

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants According to First Line Therapy Treatment Pattern From Initial Diagnosis to Current Lorlatinib Treatment
Time Frame: Baseline; data retrieved from medical records and observed in this study for approximately 5 months and 28 days
Number of participants according to first line therapy treatment pattern was reported in this outcome measure.
Baseline; data retrieved from medical records and observed in this study for approximately 5 months and 28 days
Objective Response Rate (ORR) During Lorlatinib Treatment
Time Frame: From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
ORR was defined as the percentage of participants in whom complete response (CR), or partial response (PR) was observed. According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: 1) CR is defined as disappearance of all target lesions or partial response (PR) defined as >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD .
From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
Overall Survival
Time Frame: From first dose of lorlatinib until date of death or censoring date (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
Overall survival was defined as the time from the date of first dose of lorlatinib to the date of death, censored at the participant's last contact date or the data cutoff date, whichever was earlier. Overall survival was evaluated using Kaplan-Meier method.
From first dose of lorlatinib until date of death or censoring date (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
Progression Free Survival (PFS) For Lorlatinib Treatment
Time Frame: From first dose of lorlatinib until date of death or censoring date (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
PFS refers to the duration from the first study treatment of Lorlatinib to the first documentation of disease progression or death or censored date. According to RECIST, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression. PFS was evaluated using the Kaplan-Meier method.
From first dose of lorlatinib until date of death or censoring date (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
1-year OS Rate on Lorlatinib
Time Frame: 1 year; data retrieved from medical records and observed in this study for approximately 5 months and 28 days
OS was defined as the time from the date of first dose of lorlatinib to the date of death, censored at the participant's last contact date or the data cutoff date, whichever was earlier. In this outcome measure percentage of participants who survived for 1 year are reported.
1 year; data retrieved from medical records and observed in this study for approximately 5 months and 28 days
Time to Treatment Failure (TTF) for All NSCLC Treatment
Time Frame: From date of first dose of NSCLC treatment until treatment failure (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
TTF was defined as duration of first dose of any NSCLC treatment to treatment failure (defined as any discontinuation, including cancer progression, adverse events, or death).
From date of first dose of NSCLC treatment until treatment failure (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
TTF for Lorlatinib Treatment Failure
Time Frame: From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
TTF was defined as duration of first dose of lorlatinib treatment to treatment failure (any discontinuation, including cancer progression, adverse events, or death).
From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
Number of Participants With Common Adverse Drug Reaction (ADRs)
Time Frame: From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Common ADRs were hyperlipidemia, hyperglycemia, rash & itch, mental disorder, edema, body weight gain, transaminase level escalation, peripheral neuropathy, thrombocytopenia, gastrointestinal disorder, creatine kinase increased, dizziness and pneumonitis. Lorlatinib related ADR was recorded from first dose of Lorlatinib until end of study.
From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
Duration of Common ADRs
Time Frame: From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Common ADRs were hyperlipidemia, hyperglycemia, rash & itch, mental disorder, edema, body weight gain, transaminase level escalation, peripheral neuropathy and others (thrombocytopenia, gastrointestinal disorder, creatine kinase increased, dizziness, pneumonitis). Lorlatinib related ADR was recorded from first dose of Lorlatinib until end of study. Duration of common ADR is reported in this outcome measure.
From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
Number of Participants According to Severity of Common ADRs
Time Frame: From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Number of participants with Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening) and Unknown were presented in this outcome measure. Severity grades were assessed upon investigator's discretion, wherein grade 1 was minimum severity and grade 4 was maximum severity.
From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
Number of Participants According to Type of Outcome of Common ADRs
Time Frame: From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Participants were categorized as per their ADRs outcome as: recovered, recovered with sequelae (Sequelae refer to any complication or condition that results from a pre-existing illness, injury, or medical intervention), recovering, not recovered, and unknown.
From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
objective response rate (ORR)
Time Frame: 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.
From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months.
overall survival
Time Frame: 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
From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months.
progression-free survival
Time Frame: 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
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.
1-year OS rate
Time Frame: from first dose of lorlatinib to 12 months later
percentage of survival in first year
from first dose of lorlatinib to 12 months later
time-to-treatment failure for all NSCLC
Time Frame: 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
From first dose of lorlatinib until 30 Sep 2020 or death from any cause, whichever occurred first, assessed up to 30 months.
time-to-treatment failure of lorlatinib
Time Frame: 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
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 safety profile
Time Frame: 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.
From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first, assessed upto 30 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B7461028
  • NCT06282991 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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