Dose Escalation Study of RAD001 in Combination w/Chemotherapy & Radiation in Patients With NSCLC — RAD001  

Non-Small Cell Lung Cancer Clinical Trial

Official title: A Phase I Dose Escalation Study of RAD001 in Combination With Chemotherapy and Radiation in Patients With NSCLC

Status Terminated

Clinical Trial Summary

The purpose of this study is to understand the effects (good and/or bad) of the addition of RAD001 to standard radiation and chemotherapy (cisplatin and pemetrexed) for patients with non-small cell lung cancer.

Clinical Trial Description

In oncology, clinical experience with RAD001 has been based on a number of phase I and II studies with single agent RAD001 as well as phase Ib and II studies of RAD001 in combination with other chemotherapeutic and molecular targeted agents, including paclitaxel, gemcitabine, and erlotinib among others. More recently, a phase III trial of single agent RAD001 in patients with metastatic renal cell carcinoma who had failed therapy with VEGF tyrosine kinase inhibitors was completed. Clinical experience for indications other than oncology comes from single dose studies in healthy volunteers, and studies in solid organ transplant patients, where RAD001 was administered with other immunosuppressive agents. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

• NCT number: NCT01063478
• Study type: Interventional
• Source: University of Chicago
• Status: Terminated
• Phase: Phase 1
• Start date: February 2010
• Completion date: January 2012