Conditions: Lung Cancer
Keywords: Lung Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 28
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: RAD001 in combination with Docetaxel.

Interventions: intervention 1: RAD001 intervention 2: Docetaxel
Intervention descriptions: intervention 1: RAD001 will be given at a dose of 5mg/day in combination with docetaxel intervention 2: In combination with RAD001

Protocol document: