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Completed

NCT Number: NCT06678555

A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer (NSCLC) Which Has Spread Out.

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Lorlatinib

Drug

Lorlatinib is an ALK/ROS1 tyrosin kinase inhibitor.

Other names: PF-6463992

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Number and proportion of patients receiving each regimen of systemic anti-cancer therapy

    Time frame: 74 months from 1st April, 2018

    The percentage of patients with each systemic anticancer therapy for lung cancer.

  2. 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

    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.

  3. 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

    The number and percentage of patients receiving antihyperlipidemic agents received along with lorlatinib during the same treatment period

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A RETROSPECTIVE STUDY TO EVALUATE THE REAL-WORLD EFFECTIVENESS OF LORLATINIB AMONG ROS1-POSITIVE NSCLC PATIENTS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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