Non small cell lung cancer
Conditions
Interventions
Amurubicin 35mg/m2 day1-3 Bevacizumab 15mg/kg day1 q3w
Sponsors
Gunma University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically and/or cytologically proven nonsquamous NSCLC 2.Unresectable clinical stage IV 3.Patients who have previously treated with chemotherapy (within 2 rejimens included bevacizumab. Prior EGFR TKI and ALK inhibitor treatment are not counted for 1 rejimen.) 4. Measurable or evaluable disease for RECIST 1.1.
Exclusion criteria
Exclusion criteria: 1. Symptomatic brain metastases 2. History of bleeding 3. Patient with active infection 4. Fever over 38 5. Patient with serious disease condition (severe heart disease, interstitial pneumonia, uncontrollable hypertension, diabetes mellitus, etc) 6. Obvious interstitial pneumonia , fibroid lung confirmed by CT. 7.Patient with much ascetic fluid, pleural effusion, cardiac effusion. 8. Patient with active double cancer. (Exclude disease free interval over 5 years and carcinoma in situ) 9. History of severe drug allergy 10.Patient with gastrointestinal perforation within 1 year. 11. Patient thought as of high risk of bleeding (Obvious tumor invasion to main thoracic vessel and cavity) and of thromboembolizm. 12. Receiving anticoagulant therapy. (Aspirin 325mg or less to allow) 13. History of amurubicin treatment, or other anthracycline treatment within upper limit cardiac toloreated dose(daunorubicin: 25mg/kgdoxorubicin: 500mg/m2, Epilbicine: 900mg/m2: pirarubicin: 900mg/m2, etc) 14. Considered as unfit to study drug administration by attending doctor according to clinical symptoms or laboratory abnormalities. 15. Considered to be interfere to the agreement or understanding the protocol by attening doctor. 16. Patient with impaired mental status. 17. Pregnancy 18. Other ineligible status judged by attending doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate Disease Control Rate Overall Survival Safety, Toxicity | — |
Countries
Japan
Contacts
Public ContactKyouichi Kaira
Gunma University Graduate School of Medicine Oncology Clinical Development
Outcome results
None listed