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

NCT06652555 | Not Yet Recruiting

• 1 other identifier: 2024LY0856
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ALK; NSCLC

Keywords

ALK; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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.

  2 year

Secondary Outcomes (3)

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

  1 year

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

  1 year

• Correlation analysis between CNS AEs occurrence and anti-tumor efficacy

  24 weeks

Study Arms (1)

group 1

Baseline characteristics and information during loratinib treatment were collected

Other: Group 1

Interventions

Group 1 OTHER

without Intervention

group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALK-positive NSCLC

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Officials

• Chunxia Su, Doctor

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY CHAIR

Central Study Contacts

Li Wang, Doctor

CONTACT

18170211997; leewang8023@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research Center, Shanghai Pulmonary Hospital

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 22, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): September 29, 2027
• Last Updated: October 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: up to 36 month
• Access Criteria: Send an email requesting research