Non-small cell lung cancer harboring EGFR mutation
Conditions
Interventions
Osimertinib is continued until disease progression or unless severe adverse events.
Sponsors
Showa University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Non-small cell lung cancer confirmed by histology or cytology. 2. Positive for EGFR mutation that is sensitive to osimertinib. 3. Unresectable advanced or recurrent disease. 4. Patient who is twenty-years old or more at the time of starting osimertinib therapy. 5. Performance status (ECOG criteria) is 0 to 2. 6. Patient who has measurable lesion or evaluable lesion. 7. Patient whose life time is expected 3 months or more. 8. Patient who has no severe organ function disorders, and whose laboratory test is satisfied following next criteria. 1) Neutrophil counts are 1,500/mm3 or more. 2) Platelet counts are 100,000/mm3 or more. 3) Hemoglobin value is 8.0g/dl or more. 4) AST, ALT values are until 2.5 times of upper limit of normal. 5) Total bilirubin value is until 2 mg/dl. 6) QTc interval is under 450 msec at electrocardiogram. 7) HbA1c is until 7.9%. 9. Patient who has given sufficient informed consent prior to enrollment in this study, and have obtained a consent document with a signature and date.
Exclusion criteria
Exclusion criteria: 1. Patient who has symptomatic CNS metastasis. 2. Patient who has active synchronous cancer. 3. Patient who received osimertinib therapy before. 4. Patient who has interstitial lung disease. 5. Patient who has severe infection. 6. Positive for HBs antigen and/or HCV antibody. 7. Patient who has cardiovascular diseases, for example unstable angina, myocardial infarction, that have been developed within 3 months. 8. Patient who has cerebrovascular disease, for example cerebral infarction, that have been developed within 3 months. 9. Patient who has severe uncontrolled comorbidity. 10. Patient who is unable to participate in study due to psychological disorder. 11. Patient who has severe drug sensitivity or allergy. 12. Patient who takes medicine that affect CYP3A4 such as phenytoin, carbamazepine, rifampicin, phenobarbital, itraconazole, and macrolides. 13. Patient who has contraindication to osimertinib. 14. Pregnant, lactating women or women who may become pregnant, or men who wish to have children. 15. Patient who is inappropriate for conducting study safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The relationship between amount of change for QT intervals after osimertinib administration and pharmacological factors | — |
Countries
Japan
Contacts
Public ContactHiroo Ishida
Showa University Northern Yokohama Hospital Division of Medical Oncology
Outcome results
None listed