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NCT Number: NCT06652555

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1

Other

without Intervention

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Correlation analysis between CNS AEs occurrence and anti-tumor efficacy

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Li Wang, Doctor

CONTACT

[email protected]

18170211997

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

The CNS AE of Lorlatinib in Patients with ALK-positive Advanced NSCLC

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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