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.
INCLUSION CRITERIA * newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion * ECOG performance status 0-1 * adequate organ function * clinically indicated and able to receive conventional chemoradiation therapy EXCLUSION CRITERIA * patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment * patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment
are designated in this study