advanced relapsed non-squamous NSCLC
Conditions
Interventions
If the disease is stable after four courses of CBDCA+PEM+BEV as induction therapy, patients will be treated with DTX+BEV as maintenance therapy until progression disease.
Sponsors
Respiratory Center, Showa University Northern Yokohama Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients at the age of 20 to 80 2. Confirmed as Stage3B(unsuitable for definitive radiotherapy), Stage4, or recurrent patient 3. non-squamous NSCLC 4. Patients with life expectancy for more than 3 months 5. During induction chemotherapy, Eastern Cooperative Oncology Group performance status of 0-1 During maintenance chemotherapy, Eastern Cooperative Oncology Group performance status of 0-2 6. Patients with measurable disease based on Response Evaluation Criteria in Solid Tumors(RECIST)ver.1.1. * radiation sites are not counted as measurable lesions 7. Patients with adequate organ function as following Neutrocyte 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 * Confirmed by test results within 2 weeks before registration date. The same day of the week 2 weeks before enrollment cannot be included 8. At the time of the expected date of the beginning of treatment, patients with the following period has elapsed since prior treatments No radiotherapy except for thoracic radiation within a week (exclude chest) No Exploratory thoracotomy within 4 weeks No pleural drainage within a week 9. Written informed consent can be obtained.
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic brain metastases. 2. Patients with history or complication of hemoptysis. *Definition of hemoptysis is determined by the following. A history of continuous hemoptysis over one week, or hemoptysis receiving oral or intravenous hemostatic medicine. 3. Patients with a history of severe drug allergy. 4. Patients with uncontrolled ascites, pleural effusion, or pericardial effusion 5. Patients with a history of gastrointestinal perforation within an year, or a complication of uncontrollable peptic ulcer. 6. Patients with uncontrolled hypertension 7. Patients with infectious disease requiring systemic administration of antiviral agents, antifungal agents, or antibiotics. 8. Patients receiving anticoagulant therapy 9. Patients receiving antiplatelet therapy *Patients receiving aspirin therapy up to 325mg are allowed to be registered. 10. Patients with a history of radiation to the chest, or more than 20% region of bones with hematopoietic ability 11. Patients with multiple cancers within 5years prior to initiation of the study, except for carcinoma in situ, mucosal cancer appropriately treated non-melanoma, cervical cancer, thyroid cancer, early gastric cancer, early colorectal cancer. 12. Patients with serious complications (such as heart disease, active infection, interstitial pneumonia, diabetes) 13. Pregnant woman or those with suspected pregnancy, nursing woman and those who plan to become pregnant during the study period. 14. Other patients whom the investigation considers to be unsuitable for participation in the study. 15. Patients treated with EGFR-TKI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Time to response, Disease control rate, Overall survival, Compare PFS with the change in tumor size from baseline in PFS, Compare SMT with CMT in PFS, Safety | — |
Countries
Japan
Contacts
Public ContactKyoko Fujisaki
Showa University Northern Yokohama Hospital Respiratory Center
Outcome results
None listed