Randomized phase II study of consolidation immunotherapy with nivolumab and ipilimumab or nivolumab alone following concurrent chemoradiotherapy for unresectable stage IIIA/IIIB non-small-cell lung cancer (NSCLC): Big Ten Cancer Research Consortium LUN16-081.

ABSTRACT:

Background

For unresectable stage III non-small-cell lung cancer (NSCLC), the optimal duration and regimen of consolidation immunotherapy following chemoradiation is unknown. Despite improved outcomes with 12 months of durvalumab, which has become the standard of care, new strategies to improve survival are needed. This study evaluates dual immunotherapy in the consolidation setting following concurrent chemoradiation as well as a shorter (6 months) treatment duration.

Methods

Following concurrent chemoradiation, subjects were randomized 1:1 to nivolumab alone (480 mg intravenously every 4 weeks) or combination nivolumab (240 mg intravenously every 2 weeks) and ipilimumab (1 mg/kg every 6 weeks) for up to 6 months. Primary endpoint was 18-month progression-free survival (PFS

SUBMITTER: Durm G 

PROVIDER: S-EPMC12265819 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature