A Study With Central Nervous System Metastatic EGFR Mutation Positive Non-small Cell Lung Cancer

Not yet recruiting

• Conditions: NSCLC

• Registration Number: NCT05991193
• Lead Sponsor: Hunan Province Tumor Hospital

Brief Summary

This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.

Detailed Description

This is a descriptive observational study, in which data are collected in an EGFR mutant NSCLC. Our research plan aims to use multi-omics approaches to predict the likelihood of patients developing brain metastases, assess the prognosis of brain metastasis treatment, and identify potential biomarkers.

Study Timeline

• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-06
• Study First Posted: 2023-08-14
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28
• Study Start: 2023-12-29
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients must be ≥18 years.
• Provision of fully informed consent prior to any study specific procedures.
• Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically. The mutations above may exist alone or together.
• Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC).
• According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	2 years	Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.

Secondary Outcome Measures

Name	Time	Method
Central nervous system (CNS) progression-free survival	2 years	CNS PFS is defined as the time from beginning of study treatment until the date of objective progression of central nervous system or death (by any cause in the absence of CNS progression), regardless of whether the patient withdraws from study treatment or receives another anti-cancer therapy prior to progression.
Objective Response Rate	2 years	Defined as the number (%) of patients with response of Complete Response or Partial Response

Trial Locations

Locations (1)

Hunan Cancer hospital; 🇨🇳 Changsha, Hunan, China