Hyperlipidemia, Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC, Hyperlipidemia, Lorlatinib
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.
Interventions
DRUGLorlatinib
To study hyperlipidemia frequency, levels, impact on cardiovascular events after use of Lorlatinib in NSCLC patients.
Sponsors
Peking University Third Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 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. |
| Blood lipid reduction among different lipid-lowering drugs in treating Lorlatinib-related hyperlipidemia. | From first dose of Lorlatinib to 2 years thereafter. | — |
| Overall Survival (OS) | 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. |
| Progression-free Survival (PFS) | 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. |
| Impact of lipid-lowering drugs on Lorlatinib efficacy. | 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. |
| Correlation between the duration of lorlatinib-related hyperlipidemia and maximum of carotid intima-media thickness. | From first dose of Lorlatinib to 2 years thereafter. | — |
Countries
China
Outcome results
None listed