A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02574078
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.
- Detailed Description
Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK)
\*\*Please note that the study is no longer enrolling patients for Groups A, B, C, and E.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 341
- Histologically confirmed locally advanced or stage IV NSCLC
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
- Tumor tissue sections must be available for biomarker evaluation
- Untreated or active/progressing Central Nervous system (CNS) metastases
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A SOC maintenance therapy Bevacizumab Bevacizumab specified dose on specified days Pemetrexed specified dose on specified days Group A Nivolumab Nivolumab Opdivo specified dose on specified days Group A Nivolumab + SOC maintenance therapy Nivolumab Opdivo/Bevacizumab specified dose on specified days Opdivo/Pemetrexed specified dose on specified days Group A Nivolumab + SOC maintenance therapy Bevacizumab Opdivo/Bevacizumab specified dose on specified days Opdivo/Pemetrexed specified dose on specified days Group E Nivolumab + Crizotinib Crizotinib Opdivo/Crizotinib specified dose on specified days Group A SOC maintenance therapy Pemetrexed Bevacizumab specified dose on specified days Pemetrexed specified dose on specified days Group B Nivolumab Nivolumab Opdivo specified dose on specified days Group B Best supportive care Best Supportive Care Therapy directed against specific symptoms of disease, i.e., palliative radiation or palliative surgery Group A Nivolumab + SOC maintenance therapy Pemetrexed Opdivo/Bevacizumab specified dose on specified days Opdivo/Pemetrexed specified dose on specified days Group C Investigator's choice chemotherapy nab-Paclitaxel 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 Group C Investigator's choice chemotherapy Carboplatin 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 Group D Nivolumab + Erlotinib Nivolumab Opdivo/Erlotnib specified dose on specified days Group D Erlotinib Erlotinib Erlotinib specified dose on specified days Group C Investigator's choice chemotherapy Pemetrexed 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 Group C Investigator's choice chemotherapy Paclitaxel 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 Group C Investigator's choice chemotherapy Docetaxel 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 Group C Investigator's choice chemotherapy Gemcitabine 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 Group C Nivolumb Nivolumab Opdivo specified dose on specified days Group D Nivolumab + Erlotinib Erlotinib Opdivo/Erlotnib specified dose on specified days Group E Nivolumab + Crizotinib Nivolumab Opdivo/Crizotinib specified dose on specified days
- Primary Outcome Measures
Name Time Method Overall Survival (OS), Groups A-C Only up to approximately 60 months Overall survival (OS) is defined as the time from randomization to the date of death.
Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only up to approximately 60 months Percentage of participants who experienced a treatment-related AE during the course of the study that lead to discontinuation of both study drugs.
Progression-Free Survival (PFS), Groups A-D Only up to approximately 48 months Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS), Group E Only up to approximately 48 months Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
Duration of Response (DOR), Groups A-D Only up to approximately 48 months Duration of response (DOR) is defined as the time from first confirmed response (complete response (CR) or partial response (PR)) to the date of the initial objectively documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first.
Median computed using Kaplan-Meier method.Objective Response Rate (ORR), Groups A-E up to approximately 48 months Objective response rate (ORR) is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.
Confidence interval based on the Clopper and Pearson method.Overall Survival (OS), Group D Only up to approximately 60 months Overall survival (OS) is defined as the time from randomization to the date of death.
Trial Locations
- Locations (122)
Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Texas Oncology Cancer Center - Sugar Land
🇺🇸Sugar Land, Texas, United States
Comprehensive Blood And Cancer Center
🇺🇸Bakersfield, California, United States
Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
St. Joseph Heritage Medical Group
🇺🇸Fullerton, California, United States
West KY Hematology Oncology Group PSC
🇺🇸Paducah, Kentucky, United States
Tallahassee Memorial Cancer Center
🇺🇸Tallahassee, Florida, United States
Ft. Wayne Med Onco-Hema Inc
🇺🇸Fort Wayne, Indiana, United States
University Of Maryland
🇺🇸Baltimore, Maryland, United States
Louis Stokes Cleveland VA Medical Center
🇺🇸Cleveland, Ohio, United States
Mid Ohio Oncology Hematology
🇺🇸Columbus, Ohio, United States
Rocky Mountain Cancer Centers
🇺🇸Lakewood, Colorado, United States
Memorial Cancer Institute
🇺🇸Hollywood, Florida, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Hematology Oncology Associates Of The Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
Cancer Treatment Centers Of America
🇺🇸Newnan, Georgia, United States
East Jefferson General Hospital
🇺🇸Metairie, Louisiana, United States
Bay Hematology Oncology
🇺🇸Easton, Maryland, United States
Maryland Oncology Hematology, P.A.
🇺🇸Columbia, Maryland, United States
Forrest General Cancer Center
🇺🇸Hattiesburg, Mississippi, United States
Jackson Oncology Associates, Pllc
🇺🇸Jackson, Mississippi, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Baptist Health Medical Group Oncology
🇺🇸Miami, Florida, United States
Tennessee Oncology, PLLC - SCRI - PPDS
🇺🇸Nashville, Tennessee, United States
Cancer Centers of South Texas
🇺🇸San Antonio, Texas, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
St. Mary's Hospital Regional Cancer Center
🇺🇸Grand Junction, Colorado, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Edina, Minnesota, United States
Cotton-O-Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Central Coast Med Oncology
🇺🇸Santa Maria, California, United States
New England Cancer Specialists
🇺🇸Scarborough, Maine, 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 Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
🇺🇸Tucson, Arizona, United States
Scripps Cancer Center
🇺🇸La Jolla, California, United States
UCLA Hematology/Oncology Clinic
🇺🇸Los Angeles, California, United States
Local Institution
🇺🇸Solvang, California, United States
Coastal Integrative Cancer Care
🇺🇸San Luis Obispo, California, United States
Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Eastern Ct Hem Onc Assoc
🇺🇸Norwich, Connecticut, United States
Va Ct Healthcare System
🇺🇸West Haven, Connecticut, United States
Florida Cancer Specialists S.
🇺🇸Fort Myers, Florida, United States
Florida Cancer Specialists
🇺🇸Saint Petersburg, Florida, United States
University Cancer Blood Ctr
🇺🇸Athens, Georgia, United States
Lewis Hall Singletary Oncology Center
🇺🇸Thomasville, Georgia, United States
Illinois Cancer Specialists
🇺🇸Niles, Illinois, United States
Summit Cancer Care
🇺🇸Savannah, Georgia, United States
Community Clinical Research Center
🇺🇸Anderson, Indiana, United States
Christus St. Francis Cabrini Cancer Center
🇺🇸Alexandria, Louisiana, United States
Sinai Hospital Of Baltimore
🇺🇸Baltimore, Maryland, United States
Cancer & Hematology Centers Of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
St. Louis Cancer Care, Llp
🇺🇸Bridgeton, Missouri, United States
Saint Vincent Frontier Cancer Center
🇺🇸Billings, Montana, 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
San Juan Oncology Associates
🇺🇸Farmington, New Mexico, United States
Morristown Medical Center
🇺🇸Summit, New Jersey, United States
New York Oncology Hematology, Pc
🇺🇸Albany, New York, United States
Northern Westchester Hospital
🇺🇸Mount Kisco, New York, United States
Glens Falls Hospital
🇺🇸Glens Falls, New York, United States
Columbia University Medical Center (Cumc)
🇺🇸New York, New York, United States
Broome Oncology
🇺🇸Johnson City, New York, United States
Cone Health Cancer Center
🇺🇸Greensboro, North Carolina, United States
White Plains Hospital
🇺🇸White Plains, New York, United States
Hematology-Oncology Associates Of Rockland
🇺🇸Nyack, New York, 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
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Oncology Hematology Care, Inc.
🇺🇸Cincinnati, Ohio, United States
Sanford Health
🇺🇸Fargo, North Dakota, United States
Hematology Oncology Associates
🇺🇸Medford, Oregon, United States
Oncology Associates Of Oregon, Pc
🇺🇸Eugene, Oregon, United States
Abington Hematology Oncology Associates, Inc
🇺🇸Horsham, Pennsylvania, United States
St. Luke's University Hospital Bethlehem
🇺🇸Bethlehem, Pennsylvania, United States
Erie Regional Cancer Center
🇺🇸Erie, Pennsylvania, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Sanford Research
🇺🇸Sioux Falls, South Dakota, United States
The Jones Clinic, PC
🇺🇸Germantown, Tennessee, United States
Chattanooga Oncology Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
West Cancer Center
🇺🇸Germantown, Tennessee, United States
Texas Oncology-Abilene
🇺🇸Abilene, Texas, United States
Texas Oncology - Amarillo
🇺🇸Amarillo, Texas, United States
Texas Oncology-Beaumont
🇺🇸Beaumont, Texas, United States
Texas Oncology-Arlington North
🇺🇸Arlington, Texas, United States
Texas Oncology
🇺🇸Weslaco, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Texas Oncology, P.A.
🇺🇸Webster, Texas, United States
Texas Oncology/Methodist Charlton Cancer Ctr
🇺🇸Dallas, Texas, United States
The Center For Cancer And Blood Disorders
🇺🇸Fort Worth, Texas, United States
Texas Cancer Center Of Mesquite
🇺🇸Mesquite, Texas, United States
Texas Oncology-Plano East
🇺🇸Plano, Texas, United States
Texas Oncology, Pa
🇺🇸Midland, Texas, United States
Texas Oncology Plano West Cancer Center
🇺🇸Plano, Texas, United States
Texas Cancer Center - Sherman
🇺🇸Sherman, Texas, United States
Texas Oncology-Tyler
🇺🇸Tyler, Texas, United States
Texas Oncology Cancer Care And Research Center
🇺🇸Waco, 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
Providence Regional Cancer Partnership
🇺🇸Everett, Washington, United States
Shenandoah Oncology
🇺🇸Winchester, Virginia, United States
Cancer Care Northwest
🇺🇸Spokane Valley, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
🇺🇸Yakima, Washington, United States
Northwest Cancer Specialists, Pc
🇺🇸Vancouver, Washington, United States
Edwards Comprehensive Cancer Center
🇺🇸Huntington, West Virginia, United States
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
Center For Cancer And Blood Disorders
🇺🇸Bethesda, Maryland, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Charleston Hematology Oncology Associates, Pa
🇺🇸Charleston, South Carolina, United States
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research
🇺🇸Tulsa, Oklahoma, United States
University of Florida at Shands
🇺🇸Gainesville, Florida, United States
Florida Cancer Affiliates
🇺🇸Trinity, Florida, United States
Texas Oncology-Central Austin Cancer Center
🇺🇸Austin, Texas, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States