non-small cell lung cancer
Conditions
Interventions
Add pegfilgrastim to docetaxel plus ramcirumab treatment as primary prophylaxis
Sponsors
Osaka City University Department of Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically and/or cytologically proven non-small cell lung cancer 2)Previously treated non-small cell lung cancer, with stage III of unsuitable for radiotherapy, stage IV and recurrent disease 3)Patients who have treated with at least one cytotoxic chemotherapy (In patients with driver mutations such as EGFR mutation or ALK rearrangement, tyrosine kinase inhibitor treatement is required before enrolling this study.) 4)Have measurable lesion 5)Must be 20 or more years old at the time of consent 6)Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 7)Have adequate organ function within two week before study entry 8)Estimated life expectancy of at least 12 weeks 9)Have signed an informed consent document
Exclusion criteria
Exclusion criteria: 1)Interstitial pneumonia , fibroid lung confirmed by CT. 2)History of serious drug allergy 3)Patient with much ascetic fluid, pleural effusion, cardiac effusion. 4)Obvious tumor invasion to main thoracic vessel 5)Have lung cavity 6)Histoly of hemoptysis within two months 7)History of thoracic radiation therapy 8)Tumor invasion to central airway 9)Uncontrolled coagulation disorder or receiving anticoagulant drugs 10)Have inflammatory bowel disease 11)History of thrombosis 12)Have active wounds 13)Uncontrollable hypertension 14)Proteinuria 15)Patient with active infection 16)Symptomatic brain metastases 17)Patient with active double cancers 18)Have active severe heart diseases 19)Patient with impaired mental status 20)Pregnancy 21)Other ineligible status judged by attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of febrile neutropenia during all cycles of ramucirumab plus docetaxel therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Overall survival Progression free survival Adverse events | — |
Countries
Japan
Contacts
Public ContactKenji Sawa
Osaka City University Department of Respiratory Medicine
Outcome results
None listed