A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
Phase 2
- Conditions
- non-squamous non-small cell lung cancer
- Registration Number
- JPRN-UMIN000011986
- Lead Sponsor
- Itabashi central medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Not provided
Exclusion Criteria
1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 2)known EGFR-TKI resistance gene mutation(T790M) positive 3)history of erlotinib or gefitinib treatment 4)inable of oral drug administration 5)history of myocardial infarction and cerebral infarction within one year 6)planned surgery within study term 7)history of drug allergy 8)massive,pleural effusion or ascites 9)uncontrolled infection or serious medical complications 10)active concomitant malignancy 11)mental disorder 12)pregnant or or lactating women or those who declined contraception 13)those judged not suitable by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method