NCT01167530

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer
• Locally Advanced Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-02-26
• Primary completion: 2013-07-04
• Completion: 2017-02-09
• First posted: 2010-07-22
• Last updated: 2026-04-06

Locations

1 site across 1 country: France