Refractory or relapsed non-Squamous, non-small cell lung cancer
Conditions
Sponsors
Outpatient Oncology Unit, Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-squamous NSCLC 2) Refractory or relapsed to prior chemotherapy or chemoradiotherapy (< 3 regimes) 3) Age >= 20 years 4) P.S.(ECOG) 0-2 5) Measurable lesions (RECIST) 6) Sufficient organ functions within two weeks. Defined as: 1. neutrophil count >= 1000/mm3 2. platelet >= 75,000/mm3 3. hemoglobin >= 8.0 g/dl 4. AST and ALT <= 100IU/L 5. serum bilirubin level <= 2.0 mg/dl 6. serum creatinine level <= 2.0 mg/dl 7. SaO2 >= 90% (room air) 8. Urine protein <= 1+ 7) Expected survival over 3 months 8) No major operation within 28 days 9) Provided written informed consent
Exclusion criteria
Exclusion criteria: 1) History of using EGFR-TKI 2) Active infectious disease, active other severe diseases (uncontrollable hypertension, diabetes mellitus, cardiac disease, gastro-intestinal hemorrhage etc.) 3) Hemoptysis with 2.5mL or more bleeding tendency 4) Radiological findings of cavity lesion and/or central lesion and/or tumor invasion to major vessels 5) Cardiac and/or brain infarction within 6 months 6) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 7) Brain metastasis expected bleeding 8) Ineterstitial pneumonitis on Chest CT 9) Impossible oral ingestion 10) Pleural or pericardial effusion, or ascites requiring treatment 11) Inappropriate patients for this study judged by the physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, OS, Disease Control Rate, AE | — |
Countries
Japan
Contacts
Public ContactKazuhiro Yanagihara
Kyoto University Hospital Outpatient Oncology Unit
Outcome results
None listed