Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)
Condition: Squamous Cell Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Docetaxel
Intervention MeSH terms: Docetaxel; Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 272.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the overall survival of BMS-936558 as compared with
      Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of
      prior platinum-based chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥18 years of age

          -  Subjects with histologically or cytologically-documented squamous cell NSCLC who
             present with Stage IIIB/IV disease or with recurrent or progressive disease following
             multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation
             therapy for locally advanced disease)

          -  Disease recurrence or progression during/after one prior platinum doublet-based
             chemotherapy regimen for advanced or metastatic disease

          -  Measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per
             Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤1

          -  A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of
             tumor sample (archival or recent) must be available for biomarker evaluation.
             Specimens must be received by the central lab prior to randomization. Biopsy should be
             excisional, incisional or core needle. Fine needle aspiration is insufficient

        Exclusion Criteria:

          -  Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects
             are eligible if CNS metastases are treated and subjects are neurologically returned to
             baseline for at least 2 weeks prior to enrollment. In addition, subjects must be
             either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily
             prednisone (or equivalent)

          -  Subjects with carcinomatous meningitis

          -  Subjects with active, known or suspected autoimmune disease. Subjects with type I
             diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders
             (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or
             conditions not expected to recur in the absence of an external trigger are permitted
             to enroll

          -  Subjects with a condition requiring systemic treatment with either corticosteroids or
             other immunosuppressive medications within 14 days of randomization

          -  Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1
             (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T
             lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other
             antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)

          -  Prior treatment on the first line study CA184104 first line NSCLC study

          -  Prior treatment with Docetaxel

          -  Subjects with interstitial lung disease that is symptomatic or may interfere with the
             detection or management of suspected drug-related pulmonary toxicity

          -  Treatment with any investigational agent within 14 days of first administration of
             study treatment