A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer (NSCLC) Which Has Spread Out.
A Retrospective Study to Evaluate the Real-World Effectiveness of Lorlatinib Among ROS1-Positive NSCLC Patients
2 other identifiers
observational
35
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2024
CompletedFirst Posted
Study publicly available on registry
November 7, 2024
CompletedStudy Start
First participant enrolled
July 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
February 5, 2026
February 1, 2026
12 months
November 5, 2024
February 3, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
74 months from 1st April, 2018
Secondary Outcomes (3)
Number and proportion of patients receiving each regimen of systemic anti-cancer therapy
74 months from 1st April, 2018
Mean (SD), median (interquartile range, IQR), minimum and maximum value of duration of therapy (DoT) of lorlatinib
74 months from 1st April, 2018
Number and proportion of patients receiving concomitant antihyperlipidemic agents
74 months from index date; index date is the date of the first dose of lorlatinib
Study Arms (1)
Lorlatinib
Patients with ROS1(+) advanced/metastatic NSCLC had been treated with lorlatinib.
Interventions
Lorlatinib is an ALK/ROS1 tyrosin kinase inhibitor.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- \. Patients participated in any clinical trials using lorlatinib during the observation period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Inc
Taipei, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2024
First Posted
November 7, 2024
Study Start
July 4, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.