NSCLC harboring EGFR mutation EGFR, non-small lung cancer, osimertinib
Conditions
Interventions
Take blood samples for pharmacokinetic analysis and ECG
Pharmacokinetics
Sponsors
Yamamoto Noboru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with histologically or cytologically diagnosed NSCLC harboring EGFR mutation 2. Patient with metastatic or advanced NSCLC 3. Patient who is planned to receive osimertinib therapy 4. Male and female with a registrable cohort 5. Aged > or =20 years 6. ECOG performance status or =2,000/mcL ANC > or =1,000/mcL Platelet count > or =75,000/mcL Total bilirubin < or =1.8 mg/dl AST/ALT < or =100 IU/L 8. Patient who provide written informed consent
Exclusion criteria
Exclusion criteria: 1. The prior history of osimertinib therapy 2. Concurrent anticancer therapy or immune therapy 3. Patient who receives anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before the study entry or who does not recover ( grade 1) related to prior irradiation or major surgery 6. Patient who concurrently participate in another clinical study 7. Known brain or central nerve system metastasis with unstable symptopm 8. Patient with Digestive system dysfunction or malabsorption 9. Patient with oral feeding difficulty 10. Patient with QTc prolongation (>450msec in male and >470msec in female) 11. Patient who receives CYP3A4/5 strong inhibitors or inducers 12. Serious disorders as follows Active infection Fluid retention such as pleural effusion, ascites, or pericardial effusion which requires drainage within 14 days Uncontrolled heart failure, coronary disease, arrhythmia, arterial or venous thrombosis, cerebral infarction, diabetic mellitus, autoimmune disease Evidence or past history of interstitial pneumonia or pulmonary fibrosis 13. Pregnancy or lactation 14. Known HIV infection 15. Patient whose attending physician consider as inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine RD of osimertinib in cohort based on renal function and body weight | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate PK profile of osimertinib in cohort based on renal function and body weight To evaluate toxicity of osimertinib in cohort based on renal function and body weight To evaluate response rate and disease control rate at 8 weeks | — |
Contacts
Public ContactEriko Satomi
National Cancer Center Hospital
Outcome results
None listed