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

Summary

The phase 1 study evaluats RAD001 in combination with radiotherapy in non-small cell lung cancer. 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.Radiotherapy: 66 Grays over 6.5 weeks. (5 weekly fractions of 2 Grays)Chemotherapy: 2 cycles: Cisplatin 100 mg/m2 D1, Navelbine 25 mg/m2 D1, D8, every 21 days.

Timeline

Start

2008-02-26

Primary completion

2013-07-04

Completion

2017-02-09

Drugs

Indications