Journal of Clinical Trials
Open Access

Abstract

Nivolumab Maintenance as Monotherapy after Carboplatin Plus Nab- Paclitaxel for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer: Study Protocol for Feasibility

Masao Ichiki, Ken Masuda, Chiyo Yano, Yusuke Okayama, Hanako Oda, Yohei Imamura, Hiroaki Takeoka and Tomoaki Hoshino

The aim of this study is to determine the feasibility of nivolumab as maintenance therapy after first-line chemotherapy with carboplatin plus nab-paclitaxel in non-small-cell lung cancer. Since we cannot change the dose of nivolumab, we will investigate the recommended doses and cycles of pretreatment chemotherapy with carboplatin plus nab-paclitaxel that affect maintenance therapy. The primary endpoint is incidence of any grade ≥ 3 adverse events during the first 12 weeks of nivolumab treatment. Twelve patients are required in this study.