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Brief Title: Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer
Official Title: 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.
Study ID: NCT00078390
Brief Summary: A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Scripps Cancer Institute, La Jolla, California, United States
Lombardi Cancer Center, Washington, District of Columbia, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
VA Medical Center-East Orange (study available to veterans only), East Orange, New Jersey, United States
The Cleveland Clinic, Cleveland, Ohio, United States