Observational study on patients with advanced EGFR mutation positive 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
This study looks at patients with advanced lung cancer who have certain gene mutations to see if it can help predict their chances of developing brain tumors and understand their treatment outcomes better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hunan Province Tumor Hospital Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05991193 on ClinicalTrials.gov |
What this trial studies
This observational study collects data from patients with advanced non-small cell lung cancer (NSCLC) who have specific EGFR mutations. The research aims to utilize multi-omics approaches to predict the likelihood of these patients developing brain metastases and to assess the prognosis of their treatment. By identifying potential biomarkers, the study seeks to enhance understanding of the disease's progression without intervening in current medical practices.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with untreated advanced NSCLC and specific EGFR mutations.
Not a fit: Patients without EGFR mutations or those with treated NSCLC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction and management of brain metastases in patients with EGFR mutation positive NSCLC.
How similar studies have performed: While similar observational studies have been conducted, this specific approach using multi-omics in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Changsha, Hunan
- Hunan Cancer hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Yongchang Zhang, MD
- Email: zhangyongchang@csu.edu.cn
- Phone: +8613873123436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.