Lung Cancer Clinical Trial
Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients
Summary
This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD 001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in combination with carboplatin, paclitaxel and bevacizumab
Full Description
This is a two-step, open-label, multi-center, dose escalation Phase 1 study in which RAD001 is administered in combination with carboplatin and paclitaxel (CP) in Step 1 as well as carboplatin, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced (unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced disease
Eligibility Criteria
Inclusion criteria:
Age over 18 years
Advanced Non Small Cell Lung Cancer (Stage IIIB/IV)
Ability to perform normal daily functions
Exclusion criteria:
Chronic steroid treatment
Prior treatment with chemotherapy for advanced lung cancer
Prior treatment with mTOR inhibitors
Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions
Known sensitivity to platinum compounds, taxanes or bevacizumab
Other cancers within the past 5 years
Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply
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There are 8 Locations for this study
Washington District of Columbia, 20007, United States
New Orleans Louisiana, 70115, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Adelaide South Australia, 5000, Australia
Heidelberg Victoria, 3084, Australia
Essen , 45122, Germany
Heidelberg , 69126, Germany
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