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A randomized phase II study of Erlotinib with or without Bevacizumab in NSCLC patients previouly treated with platinum-based chemotherapy containing bevacizumab. North Japan Lung Cancer Study Group Trial 1201

Phase 2
Conditions
non-squamous non-small cell lung cancer
Registration Number
JPRN-UMIN000007475
Lead Sponsor
orth Japan Lung Cancer Study Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
64
Inclusion Criteria

Not provided

Exclusion Criteria

1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 2)known active EGFR gene mutation 3)history of erlotinib or gefitinib treatment 4)inable of oral drug administration 5)current or previous histoty of hemoptysis(2.5ml)due to NSCLC 6)Risk of hemoptysis patients after thoracic radiation therapy is expected 7)With great vessel invasion 8)1cm or longer cavity in tumor 9)current or previous (within the last 1 year)history of GI perforation 10)history of myocardial infarction and cerebral infarction 11)planned surgery within study term 12)uncontrolled heypertension 13)symptomatic brain metastasis 14)history of drug allergy 15)massive,pleural effusion or ascites 16)uncontrolled infection or serious medical complications 17)active concomitant malignancy 18)mental disorder 19)pregnant or or lactating women or those who declined contraception 20)those judged not suitable by the attending physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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