Investigational study for the management of central nervous system metastasis in non-small-cell lung cancer

Not Applicable

• Conditions: on-small-cell lung cancer

• Registration Number: JPRN-UMIN000033006
• Lead Sponsor: Wakayama Medical University Respiratory Medicine/ Medical Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-01
• Study Completion: 2021-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

B. NSCLC patient sample collection phase 1. Patients who have been treated with following treatments. Cytotoxic chemotherapy within 14 days prior to osimertinib administration. The third generation EGFR-TKIs. 2. Patients who have any symptoms due to high intracranial pressure. 3. Patients who need urgent treatment such as surgery or radiation therapy to CNS metastasis. 4. Patients who have obvious infection at lumber puncture site. 5. Patients who have interstitial lung disease. 6. Patients who have uncontrolled systematic disease. 7. Patients who have difficulties in taking osimertinib tablets, or who have previous history of stomach or bowel surgeries which might affect drug absorption. 8. Patients who have hypersensitivity to osimertinib. 9. Patients who have previous history of malignant diseases. 10. Patients who have abnormal blood coagulation and whose platelet count is less than 100,000/mm3. 11. Patients who want to withdraw from this study. 12. Patients who cannot understand the contents of this study and cannot give their consent. 13. Patients who cannot follow the protocol contents of this study, or patients who are inappropriate for this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To figure out the mechanism of resistance of CNS metastasis against osimertinib.

Secondary Outcome Measures

Name	Time	Method
1. Establishment of detection assays of cell-free DNA (cfDNA) in CSF. 2. Estimation of penetration property of osimertinib by serial quantification of osimertinib concentration in plasma as well as CSF. 3. Elucidation of sequential interaction among cfDNA in plasma/CSF, circulating tumor cells, and alteration of osimertinib concentration.