Carcinoma, Non-Small-Cell LungNCT06678555
A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer (NSCLC) Which Has Spread Out.
An observational study of Carcinoma, Non-Small-Cell Lung, run by Pfizer at 1 site 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 a ROS proto-oncogene 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Lorlatinib
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Jul 2025to 14 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a retrospective, observational study to investigate effectiveness, treatment patterns, and gene mutation profile of ROS1-positive NSCLC patients who had received lorlatinib after any TKI treatment failure in Taiwan using an EMR database, NTUH-iMD. Study population consists of patients who were diagnosed with ROS1-positive NSCLC and received at least one dose of lorlatinib between 1st April, 2018, and 30th September, 2023 after any TKI treatment failure.
Who may be able to join
- Patients are aged 18 years or older on index date
- Patients have confirmed diagnosis of ROS1-positive NSCLC
- Patients have received at least one dose of lorlatinib between 1st April, 2018, and 30th September, 2023
Who cannot join
- 1. Patients participated in any clinical trials using lorlatinib during the observation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RETROSPECTIVE STUDY TO EVALUATE THE REAL-WORLD EFFECTIVENESS OF LORLATINIB AMONG ROS1-POSITIVE NSCLC PATIENTS
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 a ROS proto-oncogene 1. 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 lorlatinib 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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Lorlatinib
- 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
Lorlatinib is an ALK/ROS1 tyrosin kinase inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Lorlatinib | Patients with ROS1(+) advanced/metastatic NSCLC had been treated with lorlatinib. Receives: Drug: Lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
real-world progression-free survival
Time to real-world disease progression or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI.
Index date is the date of the first dose of lorlatinib.
Measured: 74 months from 1st April, 2018
The overall survival (OS)
Time to death during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI.
Index date is the date of the first dose of lorlatinib.
Measured: 74 months from 1st April, 2018
The real world time to next treatment (rwTTNT)
Time to subsequent treatment or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI.
Index date is the date of the first dose of lorlatinib.
Measured: 74 months from 1st April, 2018
The real world intracranial progression free survival (rwICPFS)
Time to real-world intracranial disease progression or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI.
Index date is the date of the first dose of lorlatinib.
Measured: 74 months from 1st April, 2018
Secondary outcomes (3)
Number and proportion of patients receiving each regimen of systemic anti-cancer therapy
The percentage of patients with each systemic anticancer therapy for lung cancer.
Measured: 74 months from 1st April, 2018
Mean (SD), median (interquartile range, IQR), minimum and maximum value of duration of therapy (DoT) of lorlatinib
Time to real-world discontinuation of lorlatinib or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI.
Index date is the date of the first dose of lorlatinib.
Measured: 74 months from 1st April, 2018
Number and proportion of patients receiving concomitant antihyperlipidemic agents
The number and percentage of patients receiving antihyperlipidemic agents received along with lorlatinib during the same treatment period
Measured: 74 months from index date; index date is the date of the first dose of lorlatinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start4 Jul 2025
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 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
- NCT06678555
- Sponsor's protocol ID
- B7461048
- Other IDs
- NCT06678555
- Status last verified
- Jul 2026
- First submitted
- 5 Nov 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RETROSPECTIVE STUDY TO EVALUATE THE REAL-WORLD EFFECTIVENESS OF LORLATINIB AMONG ROS1-POSITIVE NSCLC PATIENTS
- ClinicalTrials.gov ID
- NCT06678555
- Acronym / sponsor ID
- B7461048
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
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 a ROS proto-oncogene 1. 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 lorlatinib 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lorlatinib | – | Drug: LorlatinibPatients with ROS1(+) advanced/metastatic NSCLC had been treated with lorlatinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective, observational study to investigate effectiveness, treatment patterns, and gene mutation profile of ROS1-positive NSCLC patients who had received lorlatinib after any TKI treatment failure in Taiwan using an EMR database, NTUH-iMD. Study population consists of patients who were diagnosed with ROS1-positive NSCLC and received at least one dose of lorlatinib between 1st April, 2018, and 30th September, 2023 after any TKI treatment failure.
Key inclusion criteria (3 listed)
- Patients are aged 18 years or older on index date
- Patients have confirmed diagnosis of ROS1-positive NSCLC
- Patients have received at least one dose of lorlatinib between 1st April, 2018, and 30th September, 2023
Key exclusion criteria (1 listed)
- 1. Patients participated in any clinical trials using lorlatinib during the observation period.
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-6463992Lorlatinib is an ALK/ROS1 tyrosin kinase inhibitor. | Drug | Lorlatinib |
Primary outcome
real-world progression-free survival
Time frame: 74 months from 1st April, 2018
Time to real-world disease progression or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib.
The overall survival (OS)
Time frame: 74 months from 1st April, 2018
Time to death during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib.
The real world time to next treatment (rwTTNT)
Time frame: 74 months from 1st April, 2018
Time to subsequent treatment or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib.
The real world intracranial progression free survival (rwICPFS)
Time frame: 74 months from 1st April, 2018
Time to real-world intracranial disease progression or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib.
3 secondary outcomes
Number and proportion of patients receiving each regimen of systemic anti-cancer therapy
Time frame: 74 months from 1st April, 2018
Mean (SD), median (interquartile range, IQR), minimum and maximum value of duration of therapy (DoT) of lorlatinib
Time frame: 74 months from 1st April, 2018
Number and proportion of patients receiving concomitant antihyperlipidemic agents
Time frame: 74 months from index date; index date is the date of the first dose of lorlatinib
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Pfizer at 1 site 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 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
real-world progression-free survival (time frame: 74 months from 1st April, 2018). The study lists 4 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 Jul 2026.