A phase II study of Erlotinib and Bevacizumab combination therapy for previously treated III B / IV Stage non-squamous non-small cell lung cancer: IMSLC-001
- Conditions
- non-squamous non-small cell lung cancer
- Registration Number
- JPRN-UMIN000011791
- Lead Sponsor
- Itabashi Chuo Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 16
Not provided
1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 2)known EGFR-TKI resistance gene mutation positive 3)known ALK gene translocation positive 4)history of erlotinib or gefitinib treatment 5)inable of oral drug administration 6)current or previous histoty of hemoptysis(2.5ml)due to NSCLC 7)Risk of hemoptysis patients after thoracic radiation therapy is expected 8)With great vessel invasion 9)1cm or longer cavity in tumor 10)current or previous (within the last 1 year)history of GI perforation 11)history of myocardial infarction and cerebral infarction 12)planned surgery within study term 13)uncontrolled heypertension 14)symptomatic brain metastasis 15)history of drug allergy 16)massive,pleural effusion or ascites 17)uncontrolled infection or serious medical complications 18)active concomitant malignancy 19)mental disorder 20)pregnant or or lactating women or those who declined contraception 21)those judged not suitable by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS at 3months after randomized
- Secondary Outcome Measures
Name Time Method Response rate, Disease Control Rate, Progression-free survival, Overall survival, Safety, Biomarker