First Line Study of Tamibarotene in Combination for Advanced Non-Small Cell Lung Cancer
Status:
Terminated
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
The goal of this study is to determine the progression-free survival and objective response
rate in subjects with either stage IIIB with pleural effusion NSCLC or stage IV NSCLC who are
treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or
placebo. Subjects will be randomly assigned to receive tamibarotene, 6 mg/m2, divided as
twice daily orally, or an equal number of matching placebo tablets, starting 1 week before
chemotherapy and continuing through all 6 cycles and beyond. Subjects will be assessed for
response on Day 50, Day 113, then every other month using the Response Evaluation Criteria in
Solid Tumors (RECIST 1.1).