Non Small Cell Lung Cancer
Conditions
Keywords
Non Small Cell Lung Cancer, NSCLC, Advanced Lung Cancer, RAD, RAD001, chemotherapy, carboplatin, paclitaxel, bevacizumab
Brief 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
Detailed 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
Interventions
DRUGRAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
23 Years to 76 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate | Ever 3 months or once a critical DLT occurs |
Secondary
| Measure | Time frame |
|---|---|
| Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1) | End of step 1 |
| Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2) | End of Step 2 |
| PK parameters derived from PK profiles of treatment drugs alone and in combination | End of Step 1 and Step 2 |
| Best overall response - measured by CT/MRI scan every 6-8 week | Every 6-8 week |
Countries
Australia, Germany, United States
Outcome results
None listed