Non-small cell lung cancer
Conditions
Interventions
Afatinib (30 mg or 40 mg/day, day 1-21, orally) and Bevacizumab (15 mg/kg, day 1, intravenously) are administered every 3 weeks until progression. Histological and liquid rebiopsy are mandatory bef
Sponsors
Hanshin Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-small cell lung cancer (except squamous carcinoma) 2) EGFR-mutation positive 3) After Osimertinib failure, based on Jackman criteria 4) Receipt of histological rebiopsy after Osimertinib failure 5) After 4 weeks from completion of chest radiation 6) Aged older than 20 7) PS (ECOG) 0 or 1 8) Presence of measurable lesions by RECIST ver.1.1 9) Adequate organ functions 10) Life expectancy longer than 3 months 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Interstitial lung disease or pulmonary fibrosis 2) Symptomatic central nervous system metastases 3) History of severe allergic reaction to drugs 4) Severe infection or comorbidities 5) Massive or uncontrolled pleural, abdominal, or cardiac effusion 6) Clinically significant arythmia, angina, or heart failure 7) Uncontrolled hypertension 8) Uncntrolled diabetes 9) Active double cancers 10) Hitologically dominant of squanous carcinoma 11) Severe phycological disease 12) Massive hemoptysis 13) Gastrointestinal perfolation within 1 year 14) Incurable bone fracture 15) Planning major surgery during trial 16) Bleeding tendency 17) Uncontrolled thrombosis 18) Receipt of EGFR-TKIs other than Osimertinib or immunotherapy 19) Pregnancy 20) Patients whom doctos in charge judge unproper
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Disease control rate Overall survival Safety | — |
Countries
Japan
Contacts
Public ContactAkito Hata
Kobe City Mecical Center General Hospital Department of Medical Oncology
Outcome results
None listed