Lung Cancer Clinical Trial
Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens
Summary
The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Men and women ≥18 years of age
Patients with histologically or cytologically documented squamous cell nonsmall-cell lung cancer 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 chemoradiation for locally advanced disease
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
Measurable disease by computed tomography scan/magnetic resonance imaging as per Response Evaluation Criteria in Solid Tumors, volume 1.1
Exclusion Criteria:
Untreated central nervous system (CNS) metastases. Metastases have been treated and patients neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, patients must have stopped taking corticosteroids or be taking a stable or decreasing dose of ≤10 mg prednisone daily (or equivalent)
Carcinomatous meningitis
Active known or suspected autoimmune disease or interstitial lung disease
Prior treatment on either arm of study CA209-017 or CA184-104
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-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
A condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug
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There are 33 Locations for this study
Sacramento California, 95817, United States
San Diego California, 92161, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Metairie Louisiana, 70006, United States
Boston Massachusetts, 02111, United States
Southfield Michigan, 48075, United States
Rochester Minnesota, 55905, United States
Buffalo New York, 14263, United States
New York New York, 10011, United States
New York New York, 10065, United States
Chapel Hill North Carolina, 27599, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97239, United States
Allentown Pennsylvania, 18103, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77024, United States
Caen , 14000, France
Creteil , 94010, France
Pierre Benite , 69495, France
Rennes , 35033, France
Strasbourg , 67090, France
Toulouse , 31059, France
Villejuif , 94800, France
Berlin , 13125, Germany
Koeln , 50937, Germany
Muenchen , 80336, Germany
Livorno , 57100, Italy
Lucca , 55100, Italy
Terni , 05100, Italy
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