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

A Non-interventional Study and Its Clinical Relevance With Central Nervous System Metastatic Epidermal Growth Factor Receptor Mutation Positive Non-small Cell Lung Cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05991193

Enrollment

100

Registered

2023-08-14

Start date

2023-12-29

Completion date

2025-12-31

Last updated

2024-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactYongchang Zhang, MD

zhangyongchang@csu.edu.cn+8613873123436

Backup ContactNong Yang, MD

yangnong0217@163.com+8613873123436

Outcome results