Lung cancer
Conditions
Interventions
Afatinib at the dose of 40 mg is orally administered once daily and the administration is continued until progression disease or unacceptable toxicity
Sponsors
Iwate medical university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Non-small cell lung cancer (NSCLC) 2. EGFR activating mutation (exon 19 deletion or exon 21 L858R) 3. Detected T790M mutation before treatment with osimertinib 4. Stage IIIB, IV, or recurrent NSCLC 5. Have a history of first or second generation EGFR-TKI treatment 6. Progression disease after treatment with osimertinib 7. Have measurable lesion by RECIST version 1.1 8. ECOG performance status 0-1 9. Estimated life expectancy at least 4 months 10. Adequate organ function for treatment with afatinib 11. Written informed consent
Exclusion criteria
Exclusion criteria: 1. ILD or pulmonary fibrosis complication on chest X-ray 2. Other cancers 3. With severe complication 1). Uncontrollable pericardial effusion, pleural effusion, or ascites 2). Uncontrollable diabetes 3). Uncontrollable hypertension, angina pectoris, or heart failure 4). SVC syndrome or spinal cord pressure symptom 5). Severe infectious disease 4. Impossible to take drugs orally 5. History of serious drug allergies 6. Pregnancy, breast feeding, or hesitation in contraception 7. Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Response rate, Duration of response, Overall survival, safety | — |
Countries
Japan
Contacts
Public ContactHeisuke Saito
Iwate medical university Division of pulmonary medicine, allergy, and rheumatology, Department of internal medicine
Outcome results
None listed