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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
S-3304 will be administered at the tolerable dose BID along with chemo-irradiation
Standard of care chemo-irradiation
Scripps Cancer Institute
La Jolla, California, United States
Lombardi Cancer Center
Washington D.C., 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
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The Cleveland Clinic
Cleveland, Ohio, United States