A phase II study of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations(HSR1501)
- Conditions
- Advanced non-squamous non-small-cell lung cancer
- Registration Number
- JPRN-UMIN000016904
- Lead Sponsor
- Department of Internal medicine, second division, Hamamatsu Univ. School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 26
Not provided
Exclusion criteria are as follows 1: Squamous cell carcinoma 2: Active interstitial pneumonia identified by chest X-ray 3: Current or previous histoty of hemoptysis (2.5ml) due to NSCLC 4: Uncontrolled massive pleural effusion or cardiac effusion 5: Superior vena cava syndrome 6: Uncontrolled brain metastases 7: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 3 months 8: Severe infection 9: Pregnancy or lactation 10: Active concomitant malignancy 11: History of severe allergic reactions to drugs 12: Evidence of bleeding diathesis or hemoptysis 13: Current or previous history of cerebrovascular disease 14: Current or previous history of GI perforation 15: A history of chest irradaiation. 16: Exon T790M mutation detected by PCR 17: Severe and unstable medical comorbidities 18: Being unsuitable for receiving the study treatment, judged by attending physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Response rate, overall survival, safety