At a glance
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Phase 2 Randomized Study of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-Naïve Subjects With Metastatic Non-Small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating CS7017 tablets, Paclitaxel, and 2 other interventions for Metastatic Non-small Cell Lung Cancer. Completed, enrolled 111 participants across 28 sites in 4 countries.
Detailed Summary
The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin and paclitaxel to evaluate effectiveness and safety. The study will find out if adding CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in subjects with metastatic non-small cell lung cancer.
Study Details
Timeline
Interventions
CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months
Intravenous (IV), 200 mg/m\^2, once every three weeks for up to 18 weeks
IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks
Placebo tablets matching CS-7017 tablets