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Protocol No. UW18012

Principal Investigator Leal, Ticiana

Phase II

Age Group Adult

Scope National

Sponsor Type Industry; Institutional

Title 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: BTCRC-LUN16-081

Objective The purpose of this study is to test the good and bad effects of the study drugs called nivolumab and ipilimumab when given after completing chemotherapy and radiation. Researchers hope that by giving you these medications after finishing treatment, they will lengthen the amount of time your disease is not active or does not spread to another part of your body

Treatment This study has two study groups
  • Group 1 will receive the study drug nivolumab
  • Group 2 will receive study drugs nivolumab and ipilimumab

  • Description Phase 2 Consolidation Nivolumab and Ipilimumab or Nivolumab after Chemoradiation Stage IIA/IIIB NSCLC

    Key Eligibility
  • Greater than or equal to 18 years of age
  • Histological or cytological evidence of NSCLC
  • Must have unresectable or inoperable stage IIIA or IIIB disease. Subjects are considered unresectable or inoperable based on the judgment of the treating physician Subjects may have completed concurrent chemoradiation with a standard chemotherapy regimen (Cisplatin/Etoposide, Carboplatin/Paclitaxel or Cisplatin/Pemetrexed [non-squamous only]) and a dose of radiation ranging from 59.4-66.6 Gy. Subjects must have stable disease or disease response as evidenced on CT or PET scan evaluation. For those eligible, nivolumab or nivolumab/ipilimumab should begin a minimum of 28 days and a maximum 56 days following the completion of chemoradiation
    OR
  • Subjects may have completed up to 2 cycles of consolidation therapy started within 4 weeks of completion of radiation. After completion of consolidation therapy, subjects must have stable disease or disease response as evidenced by CT or PET scan evaluation. For those eligible, nivolumab or nivolumab/ipilimumab should begin 3-4 weeks after the last cycle of chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate laboratory values for protocol therapy
  • Women of childbearing potential must be willing to abstain from heterosexual activity or use an effective method of contraception
  • Men who are sexually active with WOCBP must use an effective method of contraceptive
  • Can not be pregnant or breastfeeding
  • No active central nervous system (CNS) metastases
  • No prior therapy with a PD-1, PD-L1, PD-L2 or CTLA-4 inhibitor or a lung cancer-specific vaccine therapy
  • Presence of metastatic disease (stage IV NSCLC) is not allowed
  • No active autoimmune disease requiring systemic treatment
  • Can not have a presence of interstitial lung disease or history of pneumonitis requiring treatment with corticosteroids
  • No clinically active infection
  • No history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • No history of active TB (Bacillus Tuberculosis)

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions UW Hospital and Clinics