A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors
Phase 2
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000004822
- Lead Sponsor
- Kanagawa Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
Not provided
Exclusion Criteria
1)ECOG Perfomance Status 4 2)white blood cell count; less than 2,000/mm3 3)bsolute neutrophil count; less than 1,000/mm3 4)hemoglobin; less than 7.0 g/dL 5)platelet count; less than 75,000/mm3 6)serum total bilirubin; 1.5 mg/dL or over 7)AST/ALT; 100 IU/L or over 8)serum creatinine; 1.5 mg/dL or over 9)serious complications below I)uncontrollable angina pectoris, myocardial infarction within 6 months or heart failure II)serious heart dosease III)uncontrollable diabetes or hypertension IV)infection 10)pulmonary fibrosis or interstitial pneumonitis evident on chest X ray 11)now pregnant or lactation, or possible pregnancy or refusal of contraception 12)difficult to perform or continue of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method safety, progression-free survival, overall survival