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

NCT06876675 | Enrolling By Invitation

• 1 other identifier: (2024)696-02
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer; Hyperlipidemia

Keywords

NSCLC; Hyperlipidemia; Lorlatinib

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• 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 Outcomes (6)

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

  From first dose of Lorlatinib to 2 years thereafter.

• Impact of lipid-lowering drugs on Lorlatinib efficacy.

  From first dose of Lorlatinib to 2 years thereafter.

• Correlation between the duration of lorlatinib-related hyperlipidemia and maximum of carotid intima-media thickness.

  From first dose of Lorlatinib to 2 years thereafter.

Interventions

Lorlatinib DRUG

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Treatment with other anti-cancer drugs during Lorlatinib treatment

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Hyperlipidemias

Interventions

lorlatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: March 14, 2025
• Study Start: October 15, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 14, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)