A Real-world Study on the Treatment of Non-small Cell Lung Cancer With Leptomeningeal Metastasis in China

Recruiting

• Conditions: Meningeal Metastasis; Non-Small Cell Lung Cancer

• Registration Number: NCT06718972
• Lead Sponsor: Guangzhou Medical University

Brief Summary

This is a retrospective and prospective study planned to include NSCLC patients with Leptomeningeal metastasis (LM) and treated with antitumor therapy after 2018, from multiple centers such as the First Affiliated Hospital of Guangzhou Medical University, Guangdong Sanjiu Brain Hospital, etc., aiming to establish a database related to the treatment strategies of LM patients, and to evaluate the efficacy (eg. Overall Survival/Time to Failure) and safety of different treatment strategies of LM patients, etc., as well as the significance of concomitant testing in LM patients.

Detailed Description

retrospective and prospective study

Study Timeline

• Study Start: 2024-09-01
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• non-small cell lung cancer patients with Leptomeningeal metastases diagnosed after January 2018;
• Patients who underwent antitumor therapy after diagnosis of LM.

Exclusion Criteria

• Patients with small cell lung cancer components;
• complicated with tumors other than non-small cell lung cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival(OS)	6 years

Secondary Outcome Measures

Name	Time	Method
Time to failure(TTF)	6 years
Change in cerebrospinal fluid and metabolic markers during treatment	6 years
Safety during actual clinical treatment	6 years

Trial Locations

Locations (2)

Guangdong Sanjiu Brain Hospital; 🇨🇳 Guangzhou, Guangdong, China

the First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China