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Multicenter randomized phase II study of cisplatin+pemetrexed+bevacizmab followed by maintenance pemetrexied with or without bevacizmab in patients chemoterapy-naive advanced non-squamous non-small cell lung cancer with wild type EGFR(TORG1321)

Phase 2
Conditions
Chemotherapy-naive advanced non-squamous non-samll cell lung cancer with wild type EGFR
Registration Number
JPRN-UMIN000010681
Lead Sponsor
Thoracic Oncology Tesearch Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
108
Inclusion Criteria

Not provided

Exclusion Criteria

First step(induction) 1)Symptomatic brain metastasis 2)Current history of hemoptysis 3)With pulmonary cavity lesions 4)History of radical thoracic radiotherapy 5)Active infections diseases 6)Fever over 38 degrees centigrade 7)Serious complications 8)Massive pleural and cardiac effusion and ascites that need to be immediately treated 9)Active concomitant cancers 10)Severe drug allergy 11)Uncontrollable ulcer indigestive tract 12)Perforation of the digestive tract or history within the past one year 13)Receiving anticoagulant drug (325mg and less aspirin is possible) 14) Pregnancy, breastfeeding or suspected of being pregnant 15)Those judged to be not suitable by the attending physician Second step (maintenance) 1)Symptomatic brain metastasis 2)Accompanied by serious complication in induction therapy 3) Severe drug allergy for PEM or BEM or severe adverse effect in induction therapy

Study & Design

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