Clinical trial NCT06876675: LORLATINIB-related HYPERLIPIDEMIA in ALK+ Non-Small Cell Lung Cancer
Official title: Multicenter Cohort Study of LORLATINIB-related HYPERLIPIDEMIA in ALK+ Advanced Non-Small Cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Non-Small Cell Lung Cancer
Hyperlipidemia
Keywords: NSCLC
Hyperlipidemia
Lorlatinib
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Alteration from baseline to 2 years after first dose of Lorlatinib: maximum carotid intima-media thickness and coronary CT calcification score.
timeFrame: From first dose of Lorlatinib to 2 years thereafter.
Secondary outcomes:
measure: Numbers and Time of Major adverse cardiovascular events in patients with Lorlatinib-related hyperlipidemia.
timeFrame: From first dose of Lorlatinib to at maximum of 10 years thereafter.
measure: Comparison of predictive effect on MACE between change in maximum carotid intima-media thickness and coronary artery calcium score.
timeFrame: From first dose of Lorlatinib to at maximum of 10 years thereafter.
Other outcomes:
measure: Blood lipid reduction among different lipid-lowering drugs in treating Lorlatinib-related hyperlipidemia.
timeFrame: From first dose of Lorlatinib to 2 years thereafter.
measure: Impact of lipid-lowering drugs on Lorlatinib efficacy.
timeFrame: From first dose of Lorlatinib to 2 years thereafter.
measure: Correlation between the duration of lorlatinib-related hyperlipidemia and maximum of carotid intima-media thickness.
timeFrame: From first dose of Lorlatinib to 2 years thereafter.
measure: Objective response rate (ORR)
timeFrame: From first dose of Lorlatinib to 2 years thereafter.
measure: Progression-free Survival (PFS)
timeFrame: From first dose of Lorlatinib to at maximum of 10 years thereafter.
measure: Overall Survival (OS)
timeFrame: From first dose of Lorlatinib to at maximum of 10 years thereafter.
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References: