Non-small cell lung cancer
Conditions
Interventions
Osimertinib 80 or 40 mg/day
Sponsors
North East Japan Study Group (NEJSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically or cytologically diagnosedadvanced non-small-cell lung cancer 2) Harboring EGFR active mutaion 3) Radiological progression was confirmed after 1st or 2nd generation EGFR-TKI 4) T790M mutation was confirmed 5) 5th or more days from the last dosage of EGFR-TKI 6) Age over 20 years old 7) ECOG PS 2-4 8) With evaluable lesion 9) Major organ function is satisfaction on registration in date from 14 days 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with active double cancer for 5years 2) Interstitial pneumonia 3) Poor oral intake 4) History of using immunocheckpoint therapy 5) History of taking osimertinib medication 6) The infection requiring systemic treatment 7) Patients with psychosis or psychotic symptoms is determined to be difficult to participants in a clinical trial 8) Patients with symptomatic brain metastases 9) Uncontrolled diabetes 10) Serious complications 11) Patients during systemic administration steroids therapy over 4weeks 12) Poor PS due to complication 13) A pregnant woman, a woman in breast-feeding 14-15) Patients with severe heart disease 16) Prior radiotherapy for primary or metastasis evaluable lesion 17) Patients with severe hypersensitivity 18) Patients with corneal ulcer 19) An inappropriate case judged by doctor in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Countries
Japan
Contacts
Public ContactYukari Tsubata
Shimane University Faculty of Medicine Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Outcome results
None listed