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

Shanghai Pulmonary Hospital, Shanghai, China

Status

Not yet enrolling

Conditions

ALK

NSCLC

Treatments

Other: Group 1

Study type

Observational

Funder types

Other

Identifiers

NCT06652555

2024LY0856

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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