Non-small cell lung cancer
Conditions
Interventions
the combination therapy of afatinib with bevacizumab
Sponsors
Okayama Lung Cancer Study Group (OLCSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven non-squamous cell carcinoma NSCLC 2) EGFR mutation (exon19 deletion or L858R in exon 21) 3) Unresectable or impossible of radical radiotherapy 4) IIIB/IV or postoperative recurrence 5) Chemotherapy naive 6) No radiation therapy for tumor in lung 7) Measurable disease for RECIST ver.1.1 8) Age: over 20 9) PS(ECOG): 0-1 10)Adequate organ functions judged by laboratory tests 11)Life expectancy: over 3 months 12)Written informed consent
Exclusion criteria
Exclusion criteria: 1) EGFR mutation (exon20) 2) Symptomatic brain metastases 3) Leptomeningeal carcinomatosis 4) Active double cancer 5) Hemoptysis or hemosputum 6) Hemophilic arthritis 7) Antiplatelet drug or anticoagulant 8) Uncontrolled high tension 9) Invasion to major arteries or vessels 10) Cavity of lung tumor 11) Therapy needed effusion (pleural or pericardial or ascites) 12) SVC syndrome 13) Interstitial pneumonitis or pneumonia 14) Gastrointestinal disturbance 15) Severe allergic history 16) Pregnancy 17) Inadequate patients whom physitians considered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rates of dose limiting toxicity (DLT) in each therapy dose | — |
Countries
Japan
Contacts
Public ContactTakashi Ninomiya
Okayama University Hospital Department of Respiratory Medecine
Outcome results
None listed