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): BTCRC-LUN16-081

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: non-small cell lung cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria
Histological or cytological confirmation of NSCLC
Must have unresectable or inoperable stage IIIA or IIIB disease
Prior cancer treatment must be completed at least 28 days prior to registration
Demonstrate adequate organ function
Exclusion Criteria
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
Active central nervous system metastases
Treatment with any investigational agent within 28 days prior to registration for protocol therapy
Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer other than standard concurrent chemoradiation or up to 2 cycles of consolidation
Presence of metastatic disease
Active second cancers
Evidence of active autoimmune disease requiring systemic treatment within the past 90 days or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
Interstitial lung disease or history of pneumonitis requiring treatment with corticosteroids
Diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy or other immunosuppressive therapy within 7 days of first dose of study drug
History of psychiatric illness or social situations that would limit compliance with study requirements
Clinically active infection
History of human immunodeficiency virus (HIV) infection of chronic hepatitis B or C
Has a known history of active TB
Hypersensitivity to nivolumab, ipilimumab, or any of their excipients

Recruitment Status

Open

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