A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen
Condition: Non Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1428.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to estimate the incidence and characterize the outcome of high
      grade, select adverse events in subjects with advanced or metastatic NSCLC treated with
      Nivolumab.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Target Population

          -  Subjects with histologically-or cytologically-documented NSCLC [squamous (SQ) or
             nonsquamous (NSQ)] who present with Stage IIIB/Stage IV disease (according to version
             7 of the International Association for the Study of Lung Cancer Staging Manual in
             Thoracic Oncology), or with recurrent or progressive disease following multimodal
             therapy (radiation therapy, surgical resection or definitive chemoradiotherapy for
             locally advanced disease)

          -  Subjects must have experienced disease progression or recurrence during or after at
             least one systemic therapy for advanced or metastatic disease

          -  Each subsequent line of therapy must be preceded by disease progression. A switch of
             an agent within a regimen in order to manage toxicity does not define the start of a
             new line of therapy

          -  Maintenance therapy following platinum doublet-based chemotherapy is not considered as
             a separate regimen of therapy

          -  Subjects who received platinum-containing adjuvant, neoadjuvant or definitive
             chemoradiation therapy given for locally advanced disease, and developed recurrent
             (local or metastatic) disease within 6 months of completing therapy are eligible

          -  Subjects with recurrent disease >6 months after platinum-containing adjuvant,
             neoadjuvant or definitive chemoradiation therapy given for locally advanced disease,
             who also subsequently progressed during or after a platinum doublet-based regimen
             given to treat the recurrence are eligible

          -  Subjects with non-squamous histology must be tested for Epithelial Growth Factor
             Receptor (EGFR) mutations (including, but not limited to, deletions in exon 19 and
             exon 21 [L858R] substitution) and Anaplastic Lymphoma Kinase (ALK) rearrangement if
             tests have not been previously performed. Subjects with progressive disease during or
             after EGFR or ALK tyrosine kinase inhibitor (TKI) regimens are eligible. Subjects are
             eligible if genetic test results are indeterminate or if no tumor tissue is available
             or accessible for testing as long as they have received one prior systemic therapy

          -  Experimental therapies when given as separate regimen are considered as separate line
             of therapy

          -  Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria
             (radiographic tumor assessment performed within 28 days of first dose of study drug)
             or clinically apparent disease that the investigator can follow for response per
             RECIST 1.1

          -  Eastern Cooperative Oncology Arm (ECOG) performance status (PS)

          -  PS 0 to 1

          -  PS 2

        Exclusion Criteria:

          1. Target Disease Exceptions

               -  Subjects with active central nervous system (CNS) metastases are excluded

               -  Subjects with carcinomatous meningitis

          2. Medical History and Concurrent Diseases

               -  Subjects with a history of interstitial lung disease

               -  Subjects with active, known or suspected autoimmune disease

               -  Subject whom participated in either arm of the following clinical trials
                  CA209-017, CA209-057, CA209-026, and CA184-104 or received prior treatment with
                  anti-programmed death 1 (PD-1) or anti-programmed death-ligand 1 (PDL1)
                  experimental agents

          3. Prohibited Treatments and/or Restricted Therapies

               -  Ongoing or planned administration of anti-cancer therapies other than those
                  specified in this study

               -  Use of corticosteroids or other immunosuppressive medications