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Protocol No. UW18003

Principal Investigator Leal, Ticiana

Phase III

Age Group Adult

Scope National

Sponsor Type Industry

Title A Study of Nivolumab plus Ipilimumab in Combination with Chemotherapy vs Chemotherapy alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 9LA, CA2099LA)

Objective The main purpose of the study is to see if nivolumab and ipilimumab in combination with chemotherapy is better at improving survival when compared to standard chemotherapy treatment. This study will also test the effectiveness (how well the drug works), safety, and tolerability of the nivolumab and ipilimumab combined with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). OPDIVO® (Nivolumab) and YERVOY® (ipilimumab) are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab has been approved by the FDA in the US for the treatment of metastatic melanoma (a type of skin cancer), previously treated advanced lung and kidney cancers, classical Hodgkins lymphoma and head and neck cancer. Nivolumab is approved for use in multiple countries including the United States (US, Dec-2014), the European Union (EU, Jun-2015), and Japan (Jul-2014). Ipilimumab (Yervoy™) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma. Both nivolumab and ipilimumab are investigational in this study. It is investigational to combine nivolumab and/or ipilimumab with approved chemotherapy.

Treatment If you qualify (which will be described in more detail in the study procedures section), upon entry to the study, you may participate in the Induction Phase of the study where there is a 50% chance that you will receive nivolumab in combination with ipilimumab (Treatment Arm ) and a 50% chance that you will receive platinum doublet chemotherapy (Control Arm). You will be assigned to an arm by chance, like flipping a coin. Neither you nor the study doctor can choose which arm you will be in.

Description A Phase 3 Randomized Study of Nivolumab plus Ipilimumab in Combination with Chemotherapy vs Chemotherapy alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)

Key Eligibility
  • ECOG Performance Status of ≤ 1
  • Participants must have a life expectancy of at least 3 months
  • Histologically confirmed stage IV NSCLC, squamous or non-squamous histology, with no prior systemic anti-cancer therapy (including EGFR and ALK inhibitors) given as primary therapy for advanced or metastatic disease
  • Prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiotherapy (which ever was given last) occurred at least 6 months prior to enrollment
  • Prior adjuvant or neoadjuvant chemotherapy for early stage lung cancer is permitted if completed at least 6 months prior to initiating study treatment
  • Measurable disease by CT or MRI per RECIST 1.1
  • Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period
  • Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to treatment
  • Must have adequate hematological, renal and liver function
  • Males and Females, ages ≥ 18 years of age
  • Women of childbearing potential must agree to follow instructions for methods(s) of contraception for the duration of treatment with nivolumab and 5 months after the last dose of nivolumab
  • Males who are sexually active with Women of child bearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with nivolumab and up to 7 months after the last dose of nivolumab
  • Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
  • Participants with known ALK translocations which are sensitive to available targeted inhibitor therapy are excluded
  • Participants with untreated CNS metastases are excluded
  • Participants with carcinomatous meningitis are excluded
  • Participants with an active, known or suspected autoimmune disease are excluded
  • Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment are excluded
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded
  • No prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or anyother antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection are excluded
  • Participants with ≥ Grade 2 peripheral neuropathy are excluded

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions UW Hospital and Clinics