RAD001 With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced Large Cell Lung Cancer With Neuroendocrine Differentiation

PHASE4CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Carcinoma, Large CellNeuroendocrine Tumors
Interventions
DRUG

RAD001

Participants started RAD001 treatment with a dose of 5 mg/day once daily. A dose decrease to 5 mg every other day was allowed if tolerability issues arose.

DRUG

Paclitaxel

Paclitaxel was started at doses of 175 mg/m². Dose reductions of Paclitaxel to 135 mg/m2 was permitted if tolerability issues arose.

DRUG

Carboplatin

Carboplatin was started at doses of Area under the Curve 5 (AUC 5). Dose reductions of carboplatin to AUC 4 was permitted if tolerability issues arose.

Trial Locations (9)

13125

Novartis Investigative Site, Berlin

28177

Novartis Investigative Site, Bremen

45147

Novartis Investigative Site, Essen

51109

Novartis Investigative Site, Cologne

58675

Novartis Investigative Site, Hemer

69120

Novartis Investigative Site, Heidelberg

82131

Novartis Investigative Site, Gauting

89081

Novartis Investigative Site, Ulm

04177

Novartis Investigative Site, Leipzig

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY