A phase II study of erlotinib and bevacizumab in patients with locally advanced and/or metastatic (stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) who have not received prior chemotherapy.
- Conditions
- on-Small Cell Lung Cancer
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
1. Cytologically or histologically advanced non-squamous NSCLC. Patients with squamous cell histology are eligible only if their intrathoracic disease has been completely resected, they have no current evidence of intrathoracic disease (with the exception of isolated pleural effusion), and they have not had hemoptysis in the 28 days prior to randomization;
2. No prior chemotherapy or therapy with systemic anti-tumor therapy (e.g., monoclonal antibody therapy) or prior exposure to agents directed at the HER axis (e.g. EGFR TK inhibitors, Herceptin). Prior surgery and/or localized irradiation is permitted provided that the irradiated lesion is not the only measurable lesion;
1. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease);
2. Evidence of tumour invading major blood vessels;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of erlotinib and bevacizumab in first line treatment of NSCLC as determined by the rate of no progression at 6 weeks.
- Secondary Outcome Measures
Name Time Method Efficacy of erlotinib and bevacizumab as determined by<br>1. The objective response rate;<br /><br>2. Duration of response;<br /><br>3. Time to disease progression or death;<br /><br>4. Survival; <br /><br>5. Safety of erlotinib and bevacizumab.