Phase 2 trial of neoadjuvant chemotherapy plus nivolumab with or without ipilimumab for operable non-small cell lung cancer

Two arms of the phase 2 platform NEOSTAR trial at MD Anderson Cancer Center (Houston, TX) evaluated neoadjuvant nivolumab plus chemotherapy (nivo-CT) and neoadjuvant ipilimumab plus nivolumab plus chemotherapy (ipi-nivo-CT) for operable NSCLC. The primary end point was major pathological response. MPR was 32.1% with nivo-CT and 50% with ipi-nivo-CT, meeting the primary end point in both arms. Among patients without known tumor EGFR/ALK alterations, MPR rates were 41.2% with nivo-CT and 62.5% with ipi-nivo-CT. No new safety signals were observed in either arm. The authors conclude that among patients with operable NSCLC, neoadjuvant ipi-nivo-CT enhances pathologic responses and warrants further study.