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

NCT ID: NCT06876675

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-15

Study Completion Date

2029-08-31

Brief Summary

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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

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Conditions

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Non-Small Cell Lung Cancer Hyperlipidemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Lorlatinib

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Li Liang

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Third Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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(2024)696-02

Identifier Type: -

Identifier Source: org_study_id

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