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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group 1.
- Who it may be relevant to
- Registry conditions: ALK, NSCLC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The CNS AE of Lorlatinib in Patients with ALK-positive Advanced NSCLC
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.
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.
Interventions
- Other Group 1
without Intervention
Primary outcome measures
- Incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib in real world study. [Time frame: 2 year]
Secondary outcome measures (3)
- To explore the optimized therapy management strategies for CNS AEs associated with lorlatinib in real-world study. [Time frame: 1 year]
- Analysis of factors associated with developing CNS AEs related to lorlatinib treatment. [Time frame: 1 year]
- Correlation analysis between CNS AEs occurrence and anti-tumor efficacy [Time frame: 24 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06652555 · 2024LY0856