Advanced non-squamous NSCLC
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. aged 20 years or over 2. stageIV or recurrence of post operative patient 3. pathologically confirmed non- squamous NSCLC 4. Patients with life expectancy for more than 3 months 5. Performance Status 0-1 6. treated with radiotherapy or surgery to brain metastases 7. untreated patients without EGFR-TKI 8. measurable or nonmeasurable disease 9. Patients with adequate organ function as following Neutrophil count >= 1500/mm3 Platelet count >= 100,000/mm3 Hemoglobin >= 9.0 g/dL Aspartate aminotransferase and alanine aminotransferase < 2.5 times the upper limit of normal Total bilirubin <= 1.5mg/dL Serum creatinine <= 1.5mg/dL PT-INR<1.5 Ccr>=60mL/min(CDDP), 45mL/min(CBDCA) Urine protein<=+1 10. No Exploratory thoracotomy within 4 weeks No pleural drainage within 2 weeks 11. Written informed consent can be obtained.
Exclusion criteria
Exclusion criteria: 1. symptomatic brain metastasis 2. history or complication of hemoptysis. 3. history of severe drug allergy 4. uncontrolled ascites, pleural effusion, or pericardial effusion 5. history of gastrointestinal perforation within one year, or a complication 6. uncontrolled hypertension 7. active infection requiring systemic administration of antiviral agents, antifungal agents, or antibiotics 8. antipletet therapy for chronic disease 9. irradiation to the chest or more than 20% region of bones 10. multiple cancer within 5 years 11. serious complications 12. pregnancy or lactation 13. inappropriate for this study judged by the attending physician
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| any CNS adverse effects | — |
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Countries
Japan
Contacts
Yokohama Rosai Hospital Department of Pulmonary Medicine