Study to Evaluate RAD001 in Combination With Radiotherapy in Non-small Cell Lung Cancer
Status:
Unknown status
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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.