Phase II study evaluating Erlotinib/Bevacizumab therapy as a second line therapy for advanced relapsed EGFR mutation positive non-squamous NSCLC patients who received first line combination therapy including platinum and Bevacizumab
- Conditions
- non-squamous non-small-cell lung cancer
- Registration Number
- JPRN-UMIN000009603
- Lead Sponsor
- Respiratory Center, Showa University Northern Yokohama Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 13
Not provided
1. Patients treated with EGFR-TKI 2. Patients with T790M mutation 3. Patients with history or combination of interstitial lung disease (interstitial pneumonia, pneumonitis, radiation pneumonia, BOOP, pulmonary fibrosis, ARDS, pulmorary infiltration, alveolitis, etc), and lung infection 4. Patients complicated with corneal disease, which is a problem in the clinical 5. Patients with intestinal diverticulitis 6. Patients with symptomatic brain metastases 7. Patients with history or complication of hemoptysis *Definition of hemoptysis is determined as the following. A history of continuous hemoptysis over one week, or hemoptysis receiving oral or intravenous hemostatic medicine 8. Patients with a history of severe drug allergy 9. Patients with uncontrolled ascites, pleural effusion, or pericardial effusion 10. Patients with a history of gastrointestinal perforation within an year, or a complication of uncontrollable peptic ulcer 11. Patients with uncontrolled hypertension 12. Patients with infectious disease requiring systemic administration of antiviral agents, antifungal agents, or antibiotics 13. Patients receiving antiplatelet therapy *Patients receiving aspirin therapy up to 325mg are allowed to be registered 14. Patients with a history of radiation to the chest, or more than 20% region of bones with hematopoietic ability 15. Patients with multiple cancers within 5 years prior to initiation of the study, except for carcinoma in situ, mucosal cancer appropriately treated non-melanoma, cervical cancer, thyroid cancer, early gastric cancer, early colorectal cancer 16. Patients with serious complications (such as heart disease, active infection, interstitial pneumonia, diabetes) 17. Pregnant woman or those with suspected pregnancy, nursing woman and those who plan to become pregnant during the study period 18. Other patients whom the investigator considers to be unsuitable for participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Disease control rate, Progression free survival, Overall survival, Safety, Search for predictive factors