Non-small-cell lung cancer
Conditions
Interventions
Oral osimertinib administration at a dose of 80 mg once daily, and plasma and CSF collections are planned at baseline before osimertinib treatment), 4months ( after osimertinib administration), progr
Sponsors
Wakayama Medical University Respiratory Medicine/ Medical Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A. Assay establishing phase 1. Patients who do not have any previous histories of NSCLC and who are planned lumber puncture for clinical purpose. 2. Patients who provides written informed consent. B. NSCLC patient sample collection phase 1. Patients with pathologically or cytologically confirmed NSCLC, who are planned osimertinib treatment. 2. Patients who have CNS metastasis. 3. Patients who do not need urgent treatment to improve symptoms such as surgery or radiation therapy to CNS metastasis. 4. Patients who have normal blood coagulation and platelet count should be over 100,000/mm3. Anticoagulants should be withheld for appropriate periods. 5. Performance status should be 0-2, and at least 12 week survival time should be expected. 6. Patients should be 20 years old or over. 7. Patients who understand the contents of this study and provide a written informed consent form.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To figure out the mechanism of resistance of CNS metastasis against osimertinib. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactNahomi Tokudome
Wakayama Medical University Respiratory Medicine/ Medical Oncology
Outcome results
None listed