A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT02574078
Last Updated: 2021-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
341 participants
INTERVENTIONAL
2015-11-23
2020-04-15
Brief Summary
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Detailed Description
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\*\*Please note that the study is no longer enrolling patients for Groups A, B, C, and E.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A Nivolumab
Opdivo specified dose on specified days
Nivolumab
Group A Nivolumab + SOC maintenance therapy
Opdivo/Bevacizumab specified dose on specified days
Opdivo/Pemetrexed specified dose on specified days
Nivolumab
Bevacizumab
Pemetrexed
Group A SOC maintenance therapy
Bevacizumab specified dose on specified days
Pemetrexed specified dose on specified days
Bevacizumab
Pemetrexed
Group B Nivolumab
Opdivo specified dose on specified days
Nivolumab
Group B Best supportive care
Therapy directed against specific symptoms of disease, i.e., palliative radiation or palliative surgery
Best Supportive Care
Palliative radiation, palliative surgery and/or other best supportive care treatments
Group C Investigator's choice chemotherapy
Carboplatin/nab-paclitaxel specified dose on specified days
Carboplatin/paclitaxel specified dose on specified days
Carboplatin/pemetrexed specified dose on specified days
Carboplatin/docetaxel specified dose on specified days
Carboplatin/gemcitabine specified dose on specified days
Paclitaxel specified dose on specified days
Docetaxel specified dose on specified days
Gemcitabine specified dose on specified days
Pemetrexed specified dose on specified days
Pemetrexed
nab-Paclitaxel
Paclitaxel
Docetaxel
Gemcitabine
Carboplatin
Group C Nivolumb
Opdivo specified dose on specified days
Nivolumab
Group D Erlotinib
Erlotinib specified dose on specified days
Erlotinib
Group D Nivolumab + Erlotinib
Opdivo/Erlotnib specified dose on specified days
Nivolumab
Erlotinib
Group E Nivolumab + Crizotinib
Opdivo/Crizotinib specified dose on specified days
Nivolumab
Crizotinib
Interventions
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Nivolumab
Bevacizumab
Pemetrexed
Best Supportive Care
Palliative radiation, palliative surgery and/or other best supportive care treatments
nab-Paclitaxel
Paclitaxel
Docetaxel
Gemcitabine
Erlotinib
Crizotinib
Carboplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
* Tumor tissue sections must be available for biomarker evaluation
Exclusion Criteria
* Active, known or suspected autoimmune disease
* Known history of testing positive for HIV or AIDS
* Active or chronic infection of hepatitis B virus or hepatitis C
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Texas Oncology-Beaumont
Beaumont, Texas, United States
Texas Oncology
Bedford, Texas, United States
Texas Oncology
Dallas, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Texas Oncology
Denton, Texas, United States
Texas Oncology
El Paso, Texas, United States
Texas Oncology/Methodist Charlton Cancer Ctr
Dallas, Texas, United States
Texas Oncology
Dallas, Texas, United States
Alabama Oncology
Birmingham, Alabama, United States
Southern Cancer Center Pc
Mobile, Alabama, United States
Arizona Oncology Assoc, Pc-Hal
Glendale, Arizona, United States
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
Tucson, Arizona, United States
Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Comprehensive Blood And Cancer Center
Bakersfield, California, United States
St. Joseph Heritage Medical Group
Fullerton, California, United States
Scripps Cancer Center
La Jolla, California, United States
UCLA Hematology/Oncology Clinic
Los Angeles, California, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Central Coast Med Oncology
Santa Maria, California, United States
Local Institution
Solvang, California, United States
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, United States
Rocky Mountain Cancer Centers
Lakewood, Colorado, United States
Eastern Ct Hem Onc Assoc
Norwich, Connecticut, United States
Stamford Hospital
Stamford, Connecticut, United States
Va Ct Healthcare System
West Haven, Connecticut, United States
Florida Cancer Specialists S.
Fort Myers, Florida, United States
University of Florida at Shands
Gainesville, Florida, United States
Memorial Cancer Institute
Hollywood, Florida, United States
Baptist Health Medical Group Oncology
Miami, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Hematology Oncology Associates Of The Treasure Coast
Port Saint Lucie, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Tallahassee Memorial Cancer Center
Tallahassee, Florida, United States
Florida Cancer Affiliates
Trinity, Florida, United States
University Cancer Blood Ctr
Athens, Georgia, United States
Cancer Treatment Centers Of America
Newnan, Georgia, United States
Summit Cancer Care
Savannah, Georgia, United States
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Community Clinical Research Center
Anderson, Indiana, United States
Ft. Wayne Med Onco-Hema Inc
Fort Wayne, Indiana, United States
Cotton-O-Neil Clinical Research Center
Topeka, Kansas, United States
West KY Hematology Oncology Group PSC
Paducah, Kentucky, United States
Christus St. Francis Cabrini Cancer Center
Alexandria, Louisiana, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
New England Cancer Specialists
Scarborough, Maine, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
University Of Maryland
Baltimore, Maryland, United States
Sinai Hospital Of Baltimore
Baltimore, Maryland, United States
Center For Cancer And Blood Disorders
Bethesda, Maryland, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Bay Hematology Oncology
Easton, Maryland, United States
Cancer & Hematology Centers Of Western Michigan
Grand Rapids, Michigan, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, United States
Forrest General Cancer Center
Hattiesburg, Mississippi, United States
Jackson Oncology Associates, Pllc
Jackson, Mississippi, United States
St. Louis Cancer Care, Llp
Bridgeton, Missouri, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Hunterdon Medical Center
Flemington, New Jersey, United States
Summit Medical Group
Morristown, New Jersey, United States
Atlantic Health System
Summit, New Jersey, United States
Morristown Medical Center
Summit, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
New York Oncology Hematology, Pc
Albany, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
Broome Oncology
Johnson City, New York, United States
Northern Westchester Hospital
Mount Kisco, New York, United States
Columbia University Medical Center (Cumc)
New York, New York, United States
Hematology-Oncology Associates Of Rockland
Nyack, New York, United States
White Plains Hospital
White Plains, New York, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Moses Cone Health System
Greensboro, North Carolina, United States
Randolph Cancer Center
Greensboro, North Carolina, United States
First Health Of The Carolinas
Pinehurst, North Carolina, United States
W.G. Bill Hefner VA Medical Center
Salisbury, North Carolina, United States
Cancer Care Center
Bismarck, North Dakota, United States
Sanford Health
Fargo, North Dakota, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Mid Ohio Oncology Hematology
Columbus, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research
Tulsa, Oklahoma, United States
Oncology Associates Of Oregon, Pc
Eugene, Oregon, United States
Hematology Oncology Associates
Medford, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
St. Luke's University Hospital Bethlehem
Bethlehem, Pennsylvania, United States
Erie Regional Cancer Center
Erie, Pennsylvania, United States
Abington Hematology Oncology Associates, Inc
Horsham, Pennsylvania, United States
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, United States
Greenville Health System
Greenville, South Carolina, United States
Sanford Research
Sioux Falls, South Dakota, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
The Jones Clinic, PC
Germantown, Tennessee, United States
West Cancer Center
Germantown, Tennessee, United States
Tennessee Oncology, PLLC - SCRI - PPDS
Nashville, Tennessee, United States
Texas Oncology-Abilene
Abilene, Texas, United States
Texas Oncology - Amarillo
Amarillo, Texas, United States
Texas Oncology-Arlington North
Arlington, Texas, United States
Texas Oncology-Central Austin Cancer Center
Austin, Texas, United States
Texas Oncology
Flower Mound, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Texas Oncology
Fort Worth, Texas, United States
The Center For Cancer And Blood Disorders
Fort Worth, Texas, United States
Texas Oncology
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Cancer Center Of Mesquite
Mesquite, Texas, United States
Texas Oncology, Pa
Midland, Texas, United States
Texas Oncology
New Braunfels, Texas, United States
Texas Oncology
Paris, Texas, United States
Texas Oncology-Plano East
Plano, Texas, United States
Texas Oncology Plano West Cancer Center
Plano, Texas, United States
Cancer Centers of South Texas
San Antonio, Texas, United States
Texas Cancer Center - Sherman
Sherman, Texas, United States
Texas Oncology Cancer Center - Sugar Land
Sugar Land, Texas, United States
Texas Oncology-Tyler
Tyler, Texas, United States
Texas Oncology Cancer Care And Research Center
Waco, Texas, United States
Texas Oncology, P.A.
Webster, Texas, United States
Texas Oncology
Weslaco, Texas, United States
Texas Oncology-Wichita Falls
Wichita Falls, Texas, United States
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Blacksburg, Virginia, United States
Virginia Cancer Specialists, Pc
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Shenandoah Oncology
Winchester, Virginia, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Cancer Care Northwest
Spokane Valley, Washington, United States
Northwest Cancer Specialists, Pc
Vancouver, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-370
Identifier Type: -
Identifier Source: org_study_id
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