patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations
Conditions
Interventions
afatinib 40mg/1x
Sponsors
Non Profit Organization North East Japan Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytological confirmed stage III/IV non-small cell lung cancer 2. Patients having EGFR mutation (exon 19 deletion or L858R) 3. No prior chemotherapy and no prior treatment with EGFR targeting small molecules or antibodies. 4. Measurable lesion for RECIST(ver 1.1) 5. Patients aged 75 years or older 6. ECOG performance status 0 to1 7. Adequate organ function 8. Life expectancy more than three months 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Chemotherapy, biological therapy or investigational agents for other carcinomas within four weeks prior to the start of study treatment. Hormonal treatment within 2 weeks prior to start of study treatment 2. Previous radiotherapy to the primary tumor or mesurable lesion 3. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study 4. Patients with active lung disease such as interstitial pneumonia, active radiation pneumonitis, or drug-induced pneumonitis 5. Massive pleural or pericardial effusion, or ascites 6. Symptomatic brain metastases 7. Any history or presence of poorly controlled diseases that could affect the absorption of the study drug 8. Active infection, active hepatitis B infection, active hepatitis C infection and/or known HIV carrier. 9. Other concurrent active malignancy 10. Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug 11. Pregnancy 12. Clinically significant phycological problem 13. Patients with uncontrollable complications 14. Known hypersensitivity to afatinib or the excipients of any of the trial drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival Time to Treatment Failure Overall Survival Disease Control Rate 1 and 2 Year Survival Rate Adverse Event | — |
Countries
Japan
Contacts
Public ContactYuji Minegishi
Graduate school of medicine, Nippon medical school Department of pulmonary medicine and oncology
Outcome results
None listed