Non-Small Cell Lung CarcinomaNCT06282991
A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled
An observational study of Non-Small Cell Lung Carcinoma, run by Pfizer at 6 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-Small Cell Lung Carcinoma
- What is being tested?
- Lorlatinib
- How many people
- 73 participants
- Where
- 6 sitesTaiwan
- Study dates
- 22 Jul 2020to 18 Jan 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient treated Lorlatinib other than CUP.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch
Kaohsiung City, 83301
Chung Shan Medical University Hospital
Taichung, 402
Taichung Veterans General Hospital
Taichung, 407219
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan City, 333
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Non-Small Cell Lung Carcinoma
- Being tested
- Lorlatinib
- Keywords
- ALK, TKI, Lorlatinib, RWE
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorlatinibDrug
Also called PF-6463992
ALK/ROS1 tyrosine kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Lorlatinib | Patients received lorlatinib treatment under EAP Receives: Drug: Lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants According to First Line Therapy Treatment Pattern From Initial Diagnosis to Current Lorlatinib Treatment
Number of participants according to first line therapy treatment pattern was reported in this outcome measure.
Measured: 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
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 .
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
TTF was defined as duration of first dose of lorlatinib treatment to treatment failure (any discontinuation, including cancer progression, adverse events, or death).
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start22 Jul 2020
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282991
- Sponsor's protocol ID
- B7461028
- Other IDs
- NCT06282991
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2024
- Last updated
- 10 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06282991
- Acronym / sponsor ID
- B7461028
- Conditions
- Non-Small Cell Lung Carcinoma
- Keywords
- ALK, TKI, Lorlatinib, RWE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Posted 10 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lorlatinib | – | Drug: LorlatinibPatients received lorlatinib treatment under EAP |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient treated Lorlatinib other than CUP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LorlatinibAlso: PF-6463992ALK/ROS1 tyrosine kinase inhibitor | Drug | Lorlatinib |
Primary outcome
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.
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 .
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.
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.
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.
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).
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).
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Carcinoma, run by Pfizer at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.