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Enrolling by Invitation

NCT Number: NCT06876675

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Dyslipidemias Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Lung Diseases Lung Neoplasms Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lorlatinib

Drug

To study hyperlipidemia frequency, levels, impact on cardiovascular events after use of Lorlatinib in NSCLC patients.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Blood lipid reduction among different lipid-lowering drugs in treating Lorlatinib-related hyperlipidemia.

    Time frame: From first dose of Lorlatinib to 2 years thereafter.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2029
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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