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

Not Recruiting

Trial ID: NCT02785952


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.

Official Title

A Phase III Randomized Study of Nivolumab Plus Ipilimumab Versus Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor


Inclusion Criteria:

   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

   - 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


biological: Ipilimumab

other: Laboratory Biomarker Analysis

biological: Nivolumab

other: Quality-of-Life Assessment

other: Questionnaire Administration

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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