A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/1/2018
Start Date:July 20, 2017
End Date:May 20, 2020
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email:

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A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with
chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as
the first treatment given for the disease


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or
non-squamous histology, with no prior systemic anticancer therapy

- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

- Measurable disease by CT or MRI per response evaluation criteria in solid tumors
version 1.1 (RECIST 1.1) criteria

- Participants must have PD-L1 IHC testing with results performed by a central
laboratory during the screening period

Exclusion Criteria:

- Participants with known epidermal growth factor receptor (EGFR) mutations which are
sensitive to available targeted inhibitor therapy (including, but not limited to,
deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded

- Participants with known anaplastic lymphoma kinase (ALK) translocations which are
sensitive to available targeted inhibitor therapy are excluded

- Participants with untreated CNS metastases are excluded. Participants are eligible if
CNS metastases are adequately treated and participants are neurologically returned to
baseline (except for residual signs or symptoms related to the CNS treatment) for at
least 2 weeks prior to first treatment

Other protocol inclusion/exclusion criteria may apply
We found this trial at
20
sites
Johnson City, New York 13790
Phone: 607-763-8065
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Atlanta, Georgia 30342
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Caba, Buenos Aires
Phone: +541132218956
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Charleston, South Carolina 29403
Phone: 843-577-6957
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Colorado Springs, Colorado 80909
Phone: 719-365-9645
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Colorado Springs, CO
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-293-4254
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Detroit, Michigan 48202
Phone: 313-916-4987
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Detroit, MI
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Jacksonville, Florida 32207
Phone: 904-202-7568
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Jacksonville, FL
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2508 Hamilton Road
LaGrange, Georgia 30240
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LaGrange, GA
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Phone: 717-544-0511
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Lancaster, PA
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Lexington, Kentucky 40503
Phone: 859-260-6406
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Lexington, KY
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600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
Phone: 608-262-5706
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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Madison, WI
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Marietta, Georgia 30060
Phone: 770-281-5124
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Milwaukee, Wisconsin 53226
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259 1st St
Mineola, New York 11501
(516) 663-0333
Phone: 516-663-3115
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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4800 Friendship Avenue
Pittsburgh, Pennsylvania 15206
Phone: 412-389-3059
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Pittsburgh, Pennsylvania 15232
Phone: 412-623-6121
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Plainville, Connecticut
Phone: 860-846-6240
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544 South 400 East
Saint George, Utah 84770
Phone: 435-688-4168
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Phone: 316-613-4313
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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