A randomized phase III trial comparing bexarotene/carboplatin/paclitaxel versus carboplatin/paclitaxel in chemotherapy-naive patients with advanced or metastatic non-small cell lung cancer (NSCLC)

Abstract

LBA7001 Background: Targretin (bexarotene) is a rexinoid that selectively activates RXR receptors which modulate functions associated with differentiation, inhibition of cell growth, apoptosis and metastasis. Data from four Phase I and Phase II studies suggest that combining bexarotene with chemotherapy in patients with first-line NSCLC may prolong survival. This randomized, prospective Phase III trial was performed to determine the survival benefit of adding bexarotene to carboplatin/paclitaxel chemotherapy in patients with advanced NSCLC. Methods: 612 chemo-naive NSCLC patients with Stage IIIb disease with pleural effusion or Stage IV disease, who were performance status ECOG 0–1, and had normalized triglyceride levels at study entry were enrolled. This study size will allow detection of a 30% survival improvement in the bexarotene treatment arm. Patients were stratified by disease stage and gender prior to randomization to bexarotene capsules (400 mg/m2/day) with carboplatin/paclitaxel or carboplatin/paclitaxel alone. Overall survival distribution (primary endpoint) between the arms will be analyzed by stratified log-rank test. Secondary endpoint is the one-year survival rate. Safety assessments were conducted. Efficacy and safety data will be mature and available in March, 2005. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ligand AstraZeneca, Genentech, Ligand, Lilly Oncology, Roche Ligand Amgen, AstraZeneca, Genentech, Ligand, Lilly Oncology, Pierre Fabre, Roche Amgen, AstraZeneca, Genentech, Genta, Ligand, Lilly Oncology, Roche Ligand