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Recruiting NCT05991193

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

Observational NSCLC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: NSCLC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Primary outcome measures

  • Progression-free survival [Time frame: 2 years]
Secondary outcome measures (2)
  • Central nervous system (CNS) progression-free survival [Time frame: 2 years]
  • Objective Response Rate [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Hunan Cancer hospital — Changsha

Identifiers

NCT: NCT05991193 · FORCE RWS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗