Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC
Condition: Non-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: 582.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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

Eligibility criteria:

        Inclusion Criteria:

          -  Men & women ≥18 years of age

          -  Subjects with histologically or cytologically-documented non-squamous cell NSCLC who
             present with Stage IIIB/IV disease or recurrent or progressive disease following
             multimodal therapy (radiation therapy, surgical resection, or definitive
             chemoradiation therapy for locally advanced disease) and who will receive study
             therapy as second or third line of treatment for 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
             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 asymptomatic or 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 ≤10mg daily prednisone (or equivalent)

          -  Subjects with carcinomatous meningitis

          -  Subjects with active or recent history of known or suspected autoimmune disease.
             Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone
             replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring
             systemic treatment 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 (anti-PD-1), anti-programmed cell death
             ligand 1 (anti-PD-L1), anti-programmed cell death ligand 2 (anti-PD-L2), anti-cluster
             of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen
             4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug
             specifically targeting T-cell co-stimulation or checkpoint pathways)

          -  Prior treatment with Docetaxel

          -  Treatment with any investigational agent within 14 days of first administration of
             study treatment

        Other protocol-defined inclusion/exclusion criteria apply