Nivolumab +Ipilimumab/Nivolumab +Chemotherapy vs Chemo in NSCLC

July 16, 2019

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

  • Clinical Trial Information

    Trial Contact: Jarquin-Castillo, Katherine ; Quintiliani, Jennifer; De Leon, Ma Theresa

  • IRB No: WIRB 20162615

    Protocol Abbrev: TRIO CA209-816

    Principal Investigator: Jennifer E. Tseng, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: CA209-816

    Treatment: Nivolumab, ipilimumab, chemotherapy

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT02998528

  • 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

  • Key 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