JPRN-UMIN000007475
Completed
Phase 2
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 - Randomized phase II study of 2nd line Erlotinib with or without Bevacizumab (NJLCG1201)
orth Japan Lung Cancer Study Group0 sites64 target enrollmentMarch 9, 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- orth Japan Lung Cancer Study Group
- Enrollment
- 64
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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