Phase I/II Trial of RAD001 Plus Docetaxel in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer
This is an open-label, single-arm, Phase I/II trial to determine the safety of RAD001 in
combination with docetaxel and compare the efficacy of RAD001 plus docetaxel versus
published Phase II and III reports of docetaxel alone in patients with recurrent NSCLC.
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 58 patients will participate at Emory Winship Cancer Institute and Emory
Crawford W. Long Hospital in Atlanta, Georgia.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Subjects Showing Partial Response and Stable Disease With the Combination of RAD001 and Docetaxel.
Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as reference the smallest sum Longest diameter(LD) since treatment started.
Suresh Ramalingam, MD
Emory University Winship Cancer Institute
United States: Institutional Review Board
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|