Clinical trial NCT06678555: A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer (NSCLC) Which Has Spread Out.
Official title: A Retrospective Study to Evaluate the Real-World Effectiveness of Lorlatinib Among ROS1-Positive NSCLC Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-11-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: Inclusion Criteria:

1. Patients are aged 18 years or older on index date
2. Patients have confirmed diagnosis of ROS1-positive NSCLC
3. Patients have received at least one dose of lorlatinib between 1st April, 2018, and 30th September, 2023

Exclusion Criteria:

1. Patients participated in any clinical trials using lorlatinib during the observation period.

Primary outcomes:
measure: real-world progression-free survival
timeFrame: 74 months from 1st April, 2018
measure: The overall survival (OS)
timeFrame: 74 months from 1st April, 2018
measure: The real world time to next treatment (rwTTNT)
timeFrame: 74 months from 1st April, 2018
measure: The real world intracranial progression free survival (rwICPFS)
timeFrame: 74 months from 1st April, 2018
Secondary outcomes:
measure: Number and proportion of patients receiving each regimen of systemic anti-cancer therapy
timeFrame: 74 months from 1st April, 2018
measure: Mean (SD), median (interquartile range, IQR), minimum and maximum value of duration of therapy (DoT) of lorlatinib
timeFrame: 74 months from 1st April, 2018
measure: Number and proportion of patients receiving concomitant antihyperlipidemic agents
timeFrame: 74 months from index date; index date is the date of the first dose of lorlatinib
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: