Non-small cell lung cancer
Conditions
Interventions
Osimertinib 80mg day1~ + Afatinib day1~each dose cohort Cohort1 Afatinib 20mg Cohort2 Afatinib 30mg Cohort3 Afatinib 40mg until disease progression
Sponsors
Niigata Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Non-small cell lung cancer proven by histology and / or cytology with EGFR active mutation 2) Stage IIIB, IIIC, IV or postoperative / post chmoradiation therapy recurrence 3) prior osimertinib failure 4) patients who could treat with a 80mg dose of osimertinib 5) 20 years or older 6) performance status 0 or 1 7) Adequate organ function 8) At least one or more measurable lesion by RECIST 9) Written informed consent for translational research 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who are difficult to treat enrolled doses due to toxicity of afatinib 2) History of drug-induced pneumonitis, Interstitial pneumonia 3) Symptomatic brain metastasis, leptomeningitis 4) Bone metastasis to treat by operation or radiation therapy 5) Uncontrollable pleural, peritoneal or pericardial effusion 6) Prior thoracic palliative radiotherapy within 2wks 7) SCLC transformation 8) History of active double cancer 9) Severe infection 10) Active HBV infection 11) No intention to birth control 12) Unstable psychic disorder 13) Under treatment of steroid therapy or immunosuppressive therapy 14) History of allergic reaction 15) Decision of ineligibility by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine of dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD) | — |
Countries
Japan
Contacts
Public ContactSatoru Miura
Niigata Cancer Center Hospital Department of Internal Medicine
Outcome results
None listed