Checkmate 816

Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

Objective

The purpose of this study is to determine the safety and effectiveness of nivolumab plus ipilimumab or nivolumab plus chemotherapy compared to chemotherapy alone in the treatment of Early Stage Non-Small Cell Lung Cancer.

Study Arms

  • Experimental: Nivolumab plus Ipilimumab
  • Active Comparator: Platinum doublet chemotherapy
  • Experimental: Nivolumab plus platinum doublet chemotherapy

Eligibility

  • Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
  • Lung function capacity capable of tolerating the proposed lung surgery
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Available tissue of primary lung tumor

NCT ID

NCT02998528