Non-Small Cell Lung Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Historogically or cytologically proven stage.3b or 4 non-small cell lung cancer 2)No prior treatment with EGFR-TKIs 3)PS of 0,1 or 2 4)Adequate organ functions,evaluated within 2 weeks before enrollment,as; a)T.Bil<=1.5mg/dL b)sCr<=1.2mg/dL c)SpO2(Room air)>=94% or PaO2>=65mmHg d)AST/ALT<=upper limit of normal within twice 5)Life expaectancy of more than 2 weeks 6)witten informed consent from the patient
Exclusion criteria
Exclusion criteria: 1)Patients with superior vena caval syndrome 2)Patients with compressive spinal cord lesion 3)History of hypersensitivity for drugs 4)Patients with brain metastasis or anticonvulsant medication 5)Patients with severe skin disease or treated by steroid 6)Patients with idiopathic pulomary fibrosis,pneumoconiosis,other interstitial pneumonia,idiopathic pulmonary,drug induced pulmonary damage or lungs inflammation 7)Interval from precious treatment,of following,at enrollment a)Equal or more than 4 weeks after b)Equal or more than 2 weeks after 8)active fluid in the abdomen or pleural effusion 9)Other clinically significant complications 10)Clinically significant eye diseases 11)Patients with diverticulitis 12)History of perforation of the digestive tract within one years 13)Other clinically significant cardiac disease 14)Other clinically significant psychiatric disease 15)Pregnancy,breast feeding and suspecterd pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin toxicity(Grade2) rate on the face | — |
Secondary
| Measure | Time frame |
|---|---|
| resupanse rate progression free survival overall survival safety dose intensity compliance quality of life | — |
Countries
Japan
Contacts
Showa University Northern Yokohama Hospital pharmaceutical department