A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis

• Conditions: Leptomeningeal Metastasis; Non-small Cell Lung Cancer

• Registration Number: NCT02803619
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT) chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in selected NSCLC patients in some retrospective research. Our single-center prospective research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A multi-center prospective observational biomarker study will be started in 11 lung cancer center based on our single-center prospective research result. The aims of the study are to find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical assessment criteria for NSCLC-LM EGFR-TKIs treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Status Verified: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-16
• Last Update Submitted: 2016-06-16
• Study First Posted: 2016-06-17
• Last Update Posted: 2016-06-17
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. The cytological identification of malignant cells within cerebrospinal fluid (CSF).
2. Non-small cell lung cancer patients.
3. Tumor specimens or cytology specimens can be used for the EGFR gene mutation detection.
4. The entails examining cerebrospinal fluid could be obtained by lumbar puncture.
5. Expected survival time is greater than 1 month.

Exclusion Criteria

Patients with radiologic evidence of LM not confirmed by positive CSF cytology.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival after the diagnosis of leptomeningeal metastasis in NSCLC patients	1 year

Trial Locations

Locations (1)

Department of Respiratory Medicine, Peking Union Medical College Hospita; 🇨🇳 Beijing, Beijing, China