The Incidence and Risk Factors of Central Nervous System Adverse Events of Lorlatinib in Patients with ALK-positive Advanced Non-small Cell Lung Cancer: a Real-world Study

Not yet recruiting

• Conditions: ALK; NSCLC

• Registration Number: NCT06652555
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.

Detailed Description

The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-29
• Study First Submitted QC: 2024-10-19
• Last Update Submitted: 2024-10-19
• Study First Posted: 2024-10-22
• Last Update Posted: 2024-10-22
• Study Start: 2024-10-30
• Primary Completion: 2026-09-29
• Study Completion: 2027-09-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
• ALK-positive and the test results were based on RT-PCR /FISH /IHC /NGS methods in the laboratory department or testing institution of the hospital
• receiving targeted therapy with Lorlatinib
• age ≥18 years old
• follow-up after receipt of Lorlatinib
• voluntarily participate in the study and sign informed consent

Exclusion Criteria

• evidence of any severe or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, active infections including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
• combined with other malignant tumors and received other anti-tumor therapy during the treatment of Lorlatinib

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib in real world study.	2 year	The incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib will be reported, such as cognitive effects, mood effects, speech effects and psychotic effects.

Secondary Outcome Measures

Name	Time	Method
To explore the optimized therapy management strategies for CNS AEs associated with lorlatinib in real-world study.	1 year	According to the data from CROWN study, management strategies such as to dose interruption, dose reduction or concurrent medication would minimize the impact of CNS AEs effects. However, the optimized therapy management strategies for CNS AEs associated with lorlatinib in real-world study of China needs to be further clarified.
Analysis of factors associated with developing CNS AEs related to lorlatinib treatment.	1 year	The association between baseline characteristics and CNS adverse effects will be evaluated. Baseline characteristics include age, gender, medical history, brain metastases at baseline, previous brain radiation, and lorlatinib treatment lines, among others.
Correlation analysis between CNS AEs occurrence and anti-tumor efficacy	24 weeks	Landmark analysis will be used to investigate the possible association between development of CNS AEs within 24 weeks of initiating lorlatinib and progression-free survival (PFS) as well as the objective response rate (ORR).