Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers
Condition: Recurrent Squamous Cell Lung Carcinoma; Stage IV Squamous Cell Lung Carcinoma AJCC v7
MeSH terms: Carcinoma; Lung Neoplasms
Intervention: Ipilimumab; Laboratory Biomarker Analysis; Nivolumab; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Given IV; Correlative studies; Given IV; Ancillary studies; Ancillary studies
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 275.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in
      treating patients with stage IV squamous cell lung cancer that has come back after previous
      treatment. This is a "non-match" sub-study that includes all screened patients not eligible
      for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab,
      may be able to shrink tumors. It is not yet known whether nivolumab works better with or
      without ipilimumab in treating patients with squamous cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON
             ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master
             Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)

          -  Patients must have been assigned to S1400I

          -  Patients must not have had prior treatment with an anti-programmed cell death (PD)-1,
             anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4
             antibody, or any other antibody or drug specifically targeting T-cell costimulation or
             immune checkpoint pathways

          -  Patients must not have an active, known, or suspected autoimmune disease; patients are
             permitted to enroll if they have vitiligo, type I diabetes mellitus, hypothyroidism
             only requiring hormone replacement, psoriasis not requiring systemic treatment, or
             conditions not expected to recur in the absence of an external trigger

          -  Patients must not have any known allergy or reaction to any component of the nivolumab
             and ipilimumab formulations

          -  Patients must not have received systemic treatment with corticosteroids (> 10 mg daily
             prednisone or equivalent) or other immunosuppressive medications within 14 days prior
             to sub-study registration; inhaled or topical steroids, and adrenal replacement doses
             =< 10 mg daily prednisone or equivalent are permitted in the absence of active
             autoimmune disease

          -  Patients must not have a known positive test for hepatitis B virus surface antigen
             (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or
             chronic infection; patients with a positive hepatitis C antibody with a negative viral
             load are allowed

          -  Patients must not have known history of testing positive for human immunodeficiency
             virus (HIV) or known acquired immunodeficiency syndrome (AIDS)

          -  Patients must not have interstitial lung disease that is symptomatic or disease that
             may interfere with the detection or management of suspected drug-related pulmonary
             toxicity

          -  Patients must also be offered participation in banking for future use of specimens

          -  Patients must have a lipase, amylase, TSH with reflex free T3/T4 performed within 7
             days prior to sub-study registration

          -  Patients must not have any grade III/IV cardiac disease as defined by the New York
             Heart Association Criteria (i.e., patients with cardiac disease resulting in marked
             limitation of physical activity or resulting in inability to carry on any physical
             activity without discomfort), unstable angina pectoris, and myocardial infarction
             within 6 months, or serious uncontrolled cardiac arrhythmia

               -  Patients with a history of congestive heart failure (CHF) or at risk because of
                  underlying cardiovascular disease or exposure to cardiotoxic drug should have an
                  electrocardiogram (EKG) and echocardiogram performed to evaluate cardiac function
                  as clinically indicated

               -  Patients with evidence of congestive heart failure (CHF), myocardial infarction
                  (MI), cardiomyopathy, or myositis should have a cardiac evaluation including lab
                  tests and cardiology consultations as clinically indicated including EKG,
                  creatine phosphokinase (CPK), troponin, and echocardiogram

          -  Patients who can complete Patient Reported Outcomes (PRO) forms in English are
             required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire
             and a pre-study S1400I European Quality of Life Five Dimension (EQ-5D) Questionnaire
             within 14 days prior to registration; NOTE: Patients enrolled to S1400I prior to
             9/1/2016 are not eligible for the PRO study