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NCT Number: NCT05991193

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

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.

Recruiting

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression-free survival

    Time frame: 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 outcomes

  1. Central nervous system (CNS) progression-free survival

    Time frame: 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.

  2. Objective Response Rate

    Time frame: 2 years

    Defined as the number (%) of patients with response of Complete Response or Partial Response

Study contacts

Contact information is provided by the study sponsor or research team.

Nong Yang, MD

CONTACT

[email protected]

+8613873123436

Yongchang Zhang, MD

CONTACT

[email protected]

+8613873123436

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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