Lung Cancer Clinical Trial
Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
Summary
The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy.
The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.
Eligibility Criteria
Inclusion Criteria:
Men and Women ≥ 18 years of age
Diagnosed with stage IV Non-Small Cell Lung Cancer
Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options.
Exclusion Criteria:
Subjects with untreated CNS metastases are excluded.
Subjects with carcinomatous meningitis
Subjects with an active, known or suspected autoimmune disease.
Subjects with a condition requiring systemic treatment with either corticosteroids ( > 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.
Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.
Other protocol defined inclusion/exclusion criteria apply
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There are 27 Locations for this study
San Diego California, 92123, United States
Plainville Connecticut, 06062, United States
Weston Florida, 33331, United States
Atlanta Georgia, 30322, United States
Savannah Georgia, 31405, United States
Wichita Kansas, 67214, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48202, United States
Lincoln Nebraska, 68506, United States
Hackensack New Jersey, 07601, United States
Albuquerque New Mexico, 87106, United States
Albuquerque New Mexico, 87131, United States
Albuquerque New Mexico, 87131, United States
Albuquerque New Mexico, 87131, United States
Albuquerque New Mexico, 87131, United States
Mineola New York, 11501, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27103, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15212, United States
Charleston South Carolina, 29414, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Kingston Ontario, K7L 2, Canada
Sault Ste Marie Ontario, P6B 0, Canada
St. Jerome Quebec, J7Z 5, Canada
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