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

• Conditions: Non-Small Cell Lung Cancer; Hyperlipidemia

• Registration Number: NCT06876675
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-15
• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-09
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 167

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alteration from baseline to 2 years after first dose of Lorlatinib: maximum carotid intima-media thickness and coronary CT calcification score.	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.

Secondary Outcome Measures

Name	Time	Method
Numbers and Time of Major adverse cardiovascular events in patients with Lorlatinib-related hyperlipidemia.	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.	From first dose of Lorlatinib to at maximum of 10 years thereafter.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China