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

NCT02803619 | Unknown

• 1 other identifier: ZS-595
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer; Leptomeningeal Metastasis

Keywords

Non-small cell lung cancer; leptomeningeal metastasis; EGFR sensitive mutations

Outcome Measures

Primary Outcomes (1)

• Overall survival after the diagnosis of leptomeningeal metastasis in NSCLC patients

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Leptomeningeal metastasis (LM) in patients with non-small cell lung cancer (NSCLC)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of Respiratory Medicine, Peking Union Medical College Hospita

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• Xu Y, Hu M, Zhang M, Zhong W, Yin X, Sun Y, Chen M, Zhao J, Si X, Wang H, Zhang X, Zhang L, Li J, Guan H, Yang Z, Wang M. Prospective study revealed prognostic significance of responses in leptomeningeal metastasis and clinical value of cerebrospinal fluid-based liquid biopsy. Lung Cancer. 2018 Nov;125:142-149. doi: 10.1016/j.lungcan.2018.08.017. Epub 2018 Sep 17.

  PMID: 30429013 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Meningeal Carcinomatosis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases

Central Study Contacts

Mengzhao Wang, MD

CONTACT

010-69155039; mengzhaowang@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

CN (1)