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

N/ANot Yet RecruitingNCT06652555

Shanghai Pulmonary Hospital, Shanghai, China100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

ALK NSCLC

Interventions

Group 1OTHER

without Intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib in real world study.

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.

Time frame: 2 year

Secondary Outcomes

To explore the optimized therapy management strategies for CNS AEs associated with lorlatinib in real-world study.

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.

Time frame: 1 year

Analysis of factors associated with developing CNS AEs related to lorlatinib treatment.

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.

Time frame: 1 year

Correlation analysis between CNS AEs occurrence and anti-tumor efficacy

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).

Time frame: 24 weeks

Central Contacts

Li Wang, Doctor

CONTACT

18170211997 leewang8023@163.com

Data from ClinicalTrials.gov

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