A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis
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About
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.
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Inclusion criteria
- The cytological identification of malignant cells within cerebrospinal fluid (CSF).
- Non-small cell lung cancer patients.
- Tumor specimens or cytology specimens can be used for the EGFR gene mutation detection.
- The entails examining cerebrospinal fluid could be obtained by lumbar puncture.
- Expected survival time is greater than 1 month.
Exclusion criteria
Patients with radiologic evidence of LM not confirmed by positive CSF cytology.
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Central trial contact
Mengzhao Wang, MD
Data sourced from clinicaltrials.gov
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