Phase 1b Trial of RAD001 in Patients With Operable Non-Small Cell Lung Cancer (NSCLC)
This is a Phase 1b randomized, pre-operative lung cancer trial wherein patients with
operable lung cancer will be treated with RAD001 for 3-4 weeks to study the effects of the
novel agent in relevant molecular pathways. The study will also assess the FDG uptake of the
tumor at baseline and upon completion of therapy (before surgery) with a PET scan . The
safety profile of RAD001 will also be evaluated.
New agents and regimens are urgently needed for lung cancer treatment. With the development
of novel agents and small molecules designed to curtail the aggressive aspects of this
disease, some progress has been realized. However, much more effort and insight will be
required for further real gains to be made. We propose that studying the mTOR axis, known
to be abnormal in non-small cell lung cancer (NSCLC), and translating that knowledge into
therapeutic adjustments can lead to meaningful advances in lung cancer treatment.
Approximately 35 patients will participate at Winship Cancer Institute of Emory University
in Atlanta, Georgia.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine clinical response as assessed metabolically by changes in PET scan between baseline and immediately prior to surgery.
Suresh Ramalingam, MD
Emory University Winship Cancer Institute
United States: Institutional Review Board
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|