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

NCT ID: NCT06678555

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-04

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Lorlatinib

Patients with ROS1(+) advanced/metastatic NSCLC had been treated with lorlatinib.

Lorlatinib

Intervention Type DRUG

Lorlatinib is an ALK/ROS1 tyrosin kinase inhibitor.

Interventions

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Lorlatinib

Lorlatinib is an ALK/ROS1 tyrosin kinase inhibitor.

Intervention Type DRUG

Other Intervention Names

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PF-6463992

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Inc

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7461048

To obtain contact information for a study center near you, click here.

Other Identifiers

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NCT06678555

Identifier Type: REGISTRY

Identifier Source: secondary_id

B7461048

Identifier Type: -

Identifier Source: org_study_id

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