Study to Evaluate RAD001 in Combination With Radiotherapy in Non-small Cell Lung Cancer

PHASE1UnknownINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Non-small Cell Lung CancerLocally Advanced Disease
Interventions
DRUG

Everolimus

First phase of the study:RAD001 (everolimus) will be administered per os every Monday, one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of the radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 10, 20 and 50 mg of RAD001 per week.Second phase of the study:RAD001 (everolimus) will be administered per os every day one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 2.5, 5 and 10 mg of RAD001 per day.The two phases of the study may be conducted independently and in parallel.

Trial Locations (1)

94800

RECRUITING

Institut Gustave Roussy, Villejuif

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER