A Phase I/II Study of the Safety, Pharmacokinetic Interaction and Efficacy of S-3304 in Combination With Standard Therapy in Patients With Locally Advanced Non-Small Cell Lung Cancer.
A two part study to evaluate the safety and efficacy of S-3304 in combination with standard
therapy in patients with locally advanced non-small cell lung cancer. The first part of the
study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in
combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for
further evaluation. The second part of the study is a randomized Phase II design to
evaluate the efficacy of recommended S-3304 dose in combination with chemo-radiation.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
|Lombardi Cancer Center||Washington, District of Columbia 20007|
|Scripps Cancer Institute||La Jolla, California 92037|
|University of Kansas Cancer Center||Kansas City, Kansas 66160|
|VA Medical Center-East Orange (study available to veterans only)||East Orange, New Jersey 07108|
|The Cleveland Clinic||Cleveland, Ohio 44195|