A Randomized Discontinuation Phase II Trial of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS Mutations
Allocation and Arms Additional Information: All Patients will receive an 8-week open-label
lead-in treatment of ridaforolimus. After this 8 week period patients will be re-assessed
for disease status. Patients who are stable after 8 weeks are randomized in a double-blind
fashion to continue treatment with ridaforolimus or to a placebo until disease progression.
(Those patients who have stable disease but are randomized to placebo may cross-over to
open-label ridaforolimus at the time of disease progression.) Those patients with tumor
shrinkage during the open-label lead-in treatment will continue on open-label ridaforolimus,
while those patients who have disease progression at 8-weeks are taken off-study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression-free survival (PFS) in the randomized population
Randomization (Week 8) and every 8 weeks until progressive disease or death
United States: Food and Drug Administration