Advanced stage IIIB/IV non-squamous non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-squamous, non-small cell lung cancer 2) Stage IIIB or stage IV without any indications for radiotherapy 3) No prior chemotherapy 4) Non active EGFR and ALK mutations 5) Have measurable lesions 6) Aged >=20 at the time of registration 7) ECOG performance status 0-1 8) Adequate organ function 9) Estimated life expectancy at least 12 weeks 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Symptomatic brain metastasis. 2) Current history of hemoptysis. 3) History of hypersensitivity for therapeutic agent or albumin products 4) With grade2 or more neuropathy 5) Uncontrolled ascites, pleural effusion or cardiac effusion. 6) Within 2 weeks after palliative radiotherapy 7) Within 4 weeks after operation 8) Active double malignancies 9) Fever over 38C 10) serious medical complications 11) Receiving anticoagulant drug (325mg and less aspirin is possible) 12) Pregnancy, breastfeeding or suspected of being pregnant 13) HBs positive patient 14) Others judged by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1:Decision of recommend dose and schedule Phase 2: Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival(OS) Progression-free survival(PFS) Safety | — |
Countries
Japan
Contacts
National Hospital Organization Shikoku Cancer Center Department of thoracic oncology