Neoadjuvant chemotherapy plus nivolumab with or without ipilimumab in operable non-small cell lung cancer: the phase 2 platform NEOSTAR trial

Abstract Neoadjuvant ipilimumab + nivolumab (Ipi+Nivo) and nivolumab + chemotherapy (Nivo+CT) induce greater pathologic response rates than CT alone in patients with operable non-small cell lung cancer (NSCLC). The impact of adding ipilimumab to neoadjuvant Nivo+CT is unknown. Here we report the results and correlates of two arms of the phase 2 platform NEOSTAR trial testing neoadjuvant Nivo+CT and Ipi+Nivo+CT with major pathologic response (MPR) as the primary endpoint. MPR rates were 32.1% (7/22, 80% confidence interval (CI) 18.7–43.1%) in the Nivo+CT arm and 50% (11/22, 80% CI 34.6–61.1%) in the Ipi+Nivo+CT arm; the primary endpoint was met in both arms. In patients without known tumor EGFR / ALK…

• CC
  Conquer Cancer Foundation
• BS
  Bristol-Myers Squibb
• AS
  Andrew Sabin Family Foundation
• KB
  Khalifa Bin Zayed Al Nahyan Foundation
• NI
  National Institutes of Health

  Awards: CA016672, 5P50CA070907, 1S10OD024977, 1S10OD024977-01, P30 CA016672, R01CA262425
• UO
  University of Texas MD Anderson Cancer Center

  Awards: CA016672, P30 CA016672
• NC
  National Cancer Institute

  Awards: P30 CA016672, CA016672, 1S10OD024977, R01CA248731, T32CA217789, 5P50CA070907