Non-small cell lung cancer
Conditions
Interventions
Afatinib is prescribed at 30 mg/day everyday, and bevacizumab is injected at 15 mg/kg every 3 weeks until progressive disease. If possible, rebiopsy is performed to confirm T790M status. To eval
Sponsors
Foundation for Biomedical Research and Innovation
HANSHIN Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histological or cytological proven NSCLC (except squamous hislotogy) 2)EGFR mutation positive 3)After acquired resistance to EGFR-TKI (briefly, SD>6 months, defined by Jackman criteria) 4)Interval of radiation therapy: 4 weeks after thoracic RT and 1 week after non-thoracic RT 5)Age: over 20 6)ECOG PS: 0-2 7)Adequate organ functions judged by laboratory tests 8)Life expectancy: over 3 months 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Obvious interstitial pneumonia or pulmonary fibrosis by chest CT 2)History of severe allergic reaction 3)Complications such as severe infection or severe comobidities 4)Uncontrolled pleural or pericardial effusion 5)Clinically significant heart disease 6)Uncontrolled hypertension 7)Uncontrolled diabate 8)Active multiple cancer 9)Squamous histology 10)Aparent invasion of main vessels 11)Clinically significant phycological problem 12)History of significant hemoptysis or respiratory bleeding 13)History of GI perfolation 14)non-curable bone fracture or severe injury 15)Planning surgery 16)Significant lung cavitation 17)Bleeding tendency 18)Uncontrolled thromboembolism 19)Prior therapy of EGFR-TKI+bevacizumab 20)History of Afatinib administration 21)Pregnancy 22)Inadequate patients whom physitians considered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Disease control rate Overall survival Safety | — |
Countries
Japan
Contacts
Public ContactAkito Hata
Institute of Biomedical Research and Innovation Division of Integrated Oncology
Outcome results
None listed