LORLATINIB-related HYPERLIPIDEMIA in ALK+ Non-Small Cell Lung Cancer

March 13, 2025 updated by: Li Liang, Peking University Third Hospital

Multicenter Cohort Study of LORLATINIB-related HYPERLIPIDEMIA in ALK+ Advanced Non-Small Cell Lung Cancer Patients

The goal of this observational study is to learn about the long-term effects of Lorlatinib related hyperlipidemia in NSCLC patients who take Lorlatinib for at least 21 days. The main question it aims to answer is:

  • Whether blood lipids have been lowered down to an anticipated level within recommended range after the initial revealed Lorlatinib related hyperlipidemia?
  • Will it be harmful to the cardiovascular system when blood lipids were not lowered down to normal levels in these cancer patients treated with Lorlatinib, i.e. major adverse cardiac events (MACE), or instead, carotid artery intima-media thickness.

Participants already taking Lorlatinib as part of their regular medical care for NSCLC will answer online survey questions.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

167

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Advanced NSCLC patients with ALK fusion positive who were treated with Lorlatinib as first- or later- line therapy will be enrolled from 10 tertiary hospitals in China.

Description

Inclusion Criteria:

  • Advanced ALK+ NSCLC diagnosed by patholgy and/or cytology
  • ECOG 0-2
  • Age 18-80 years
  • Taken Lorlatinib for at least 20 days
  • Signed informed consent.

Exclusion Criteria:

  • Treatment with other anti-cancer drugs during Lorlatinib treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alteration from baseline to 2 years after first dose of Lorlatinib: maximum carotid intima-media thickness and coronary CT calcification score.
Time Frame: From first dose of Lorlatinib to 2 years thereafter.

Maximum carotid intima-media thickness: the higher the worse. It is a value directly determined under carotid ultrasound.

CT: Computed Tomography Coronary CT calcification score: the higher the worse. It is a value directly determined by coronary calcium scan.
From first dose of Lorlatinib to 2 years thereafter.

Secondary Outcome Measures

Outcome Measure
Time Frame
Numbers and Time of Major adverse cardiovascular events in patients with Lorlatinib-related hyperlipidemia.
Time Frame: From first dose of Lorlatinib to at maximum of 10 years thereafter.
From first dose of Lorlatinib to at maximum of 10 years thereafter.
Comparison of predictive effect on MACE between change in maximum carotid intima-media thickness and coronary artery calcium score.
Time Frame: From first dose of Lorlatinib to at maximum of 10 years thereafter.
From first dose of Lorlatinib to at maximum of 10 years thereafter.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood lipid reduction among different lipid-lowering drugs in treating Lorlatinib-related hyperlipidemia.
Time Frame: From first dose of Lorlatinib to 2 years thereafter.
From first dose of Lorlatinib to 2 years thereafter.
Impact of lipid-lowering drugs on Lorlatinib efficacy.
Time Frame: From first dose of Lorlatinib to 2 years thereafter.

The Lorlatinib efficacy is clinically measured as per RECIST1.1. Normally patients receiving Lorlatinib will undergo clinical routine CT scans every 1-2 months. Since this study is an observational study, we do not request the time interval for each round of CT scans-just as good as clinical routine.

In this study, the Lorlatinib efficacy mainly refers to objective response rate(ORR), progression-free survival(PFS) and overall survival(OS). We aim to compare whether different lipid-lowering drugs may have different Lorlatinib efficacy in this prospective cohort.
From first dose of Lorlatinib to 2 years thereafter.
Correlation between the duration of lorlatinib-related hyperlipidemia and maximum of carotid intima-media thickness.
Time Frame: From first dose of Lorlatinib to 2 years thereafter.
From first dose of Lorlatinib to 2 years thereafter.
Objective response rate (ORR)
Time Frame: From first dose of Lorlatinib to 2 years thereafter.
The Lorlatinib efficacy is clinically measured as per RECIST1.1. Normally patients receiving Lorlatinib will undergo clinical routine CT scans every 1-2 months. Since this study is an observational study, we do not request the time interval for each round of CT scans-just as good as clinical routine.
From first dose of Lorlatinib to 2 years thereafter.
Progression-free Survival (PFS)
Time Frame: From first dose of Lorlatinib to at maximum of 10 years thereafter.

The Lorlatinib efficacy is clinically measured as per RECIST1.1. PFS is defined as the time from the first dose of Lorlatinib to disease progression.

Normally patients receiving Lorlatinib will undergo clinical routine CT scans every 1-2 months. Since this study is an observational study, we do not request the time interval for each round of CT scans-just as good as clinical routine.
From first dose of Lorlatinib to at maximum of 10 years thereafter.
Overall Survival (OS)
Time Frame: From first dose of Lorlatinib to at maximum of 10 years thereafter.

The Lorlatinib efficacy is clinically measured as per RECIST1.1. OS is defined as the time from the first dose of Lorlatinib to the date of death.

Normally patients receiving Lorlatinib will undergo clinical routine CT scans every 1-2 months. Since this study is an observational study, we do not request the time interval for each round of CT scans-just as good as clinical routine.
From first dose of Lorlatinib to at maximum of 10 years thereafter.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (2024)696-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will only be acquired by contacting investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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