An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/1/2018 |
| Start Date: | August 5, 2015 |
| End Date: | December 31, 2020 |
| Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: |
| Email: | Clinical.Trials@bms.com |
An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or
Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or
overall survival compared with chemotherapy in patients with advanced lung cancer.
Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or
overall survival compared with chemotherapy in patients with advanced lung cancer.
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or
non-squamous histology, with no prior systemic anticancer therapy
- Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC)
testing, with results, performed by the central lab during the Screening period
- 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
Exclusion Criteria:
- Subjects with untreated Central nervous system (CNS) metastases are excluded
- Subjects with an active, known or suspected autoimmune disease are excluded
- Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency
virus (HIV) indicating acute or chronic infection
Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
32
sites
Emory University Hospital As the largest health care system in Georgia and the only health...
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Baltimore, Maryland 21231
410-955-6190
Phone: 443-287-9377
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
Phone: 716-845-3114
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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1801 Inwood Rd
Dallas, Texas 75390
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-1688
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 646-888-4863
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-503-5743
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-362-4140
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
(801) 585-0303
Phone: 801-587-4391
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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45 Castro Street
San Francisco, California 94114
San Francisco, California 94114
(415) 600-6000
Phone: 415-600-1654
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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