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

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 Overview

• Status: Not yet recruiting
• Conditions: NSCLC; ALK
• Intervention / Treatment: Other: Group 1

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Li Wang, Doctor; Phone Number: 18170211997; Email: leewang8023@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ALK-positive NSCLC

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1; Baseline characteristics and information during loratinib treatment were collected	Other: Group 1; without Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	24 weeks

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Study Chair: Chunxia Su, Doctor, Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2024
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): September 29, 2027

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: October 19, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: NSCLC; ALK
• Other Study ID Numbers: 2024LY0856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: research article
• IPD Sharing Time Frame: up to 36 month
• IPD Sharing Access Criteria: Send an email requesting research
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No