EGFR mutation-positive non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adequate organ function 2) Histologically or cytologically confirmed EGFR mutation-positive non-small cell lung cancer 3) Afatinib has not been administered in the past 4) 20 years or older 5) Estimated life expectancy at least 3 months 6)Performance Status (ECOG) 0-2 7)With written informed consent
Exclusion criteria
Exclusion criteria: 1) over Grade 2 of diarrhea, a severe gastrointestinal disorder 2)over Grade 2 of skinl disorder 3)over Grade 2 of mucositis 4)Interstitial lung disease 5) aldosteronism 6) myopathy 7) hypokalemia 8) uncontrolled complications 9) No pregnancy, during nursing 10) infection of HBV, HCV, and HIV 11). History of sensitivity of Afatinb, Hangeshashin-to and tetracycline antibiotic 12)In addition, the primary doctor judging inappropriate for entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In 4 weeks time severe diarrhea(onset of Grade 3 or 48 hours or more of Grade 2 of diarrhea) expression rate by Afatinib | — |
Countries
Japan
Contacts
National Hospital Organization Kyushu Medical Center Department of Respiratory Medicine