Lung Cancer Clinical Trial

A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen

Summary

The purpose of this study is to estimate the incidence and characterize the outcome of high grade, select adverse events in subjects with advanced or metastatic NSCLC treated with Nivolumab.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

1. Target Population

Subjects with histologically-or cytologically-documented NSCLC [squamous (SQ) or nonsquamous (NSQ)] 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 chemoradiotherapy for locally advanced disease)
Subjects must have experienced disease progression or recurrence during or after at least one systemic therapy for advanced or metastatic disease
Each subsequent line of therapy must be preceded by disease progression. A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapy
Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy
Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
Subjects with recurrent disease >6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible
Subjects with non-squamous histology must be tested for Epithelial Growth Factor Receptor (EGFR) mutations (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution) and Anaplastic Lymphoma Kinase (ALK) rearrangement if tests have not been previously performed. Subjects with progressive disease during or after EGFR or ALK tyrosine kinase inhibitor (TKI) regimens are eligible. Subjects are eligible if genetic test results are indeterminate or if no tumor tissue is available or accessible for testing as long as they have received one prior systemic therapy
Experimental therapies when given as separate regimen are considered as separate line of therapy
Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria (radiographic tumor assessment performed within 28 days of first dose of study drug) or clinically apparent disease that the investigator can follow for response per RECIST 1.1
Eastern Cooperative Oncology Arm (ECOG) performance status (PS)
PS 0 to 1
PS 2

Exclusion Criteria:

Target Disease Exceptions

Subjects with active central nervous system (CNS) metastases are excluded
Subjects with carcinomatous meningitis

Medical History and Concurrent Diseases

Subjects with a history of interstitial lung disease
Subjects with active, known or suspected autoimmune disease
Subject whom participated in either arm of the following clinical trials CA209-017, CA209-057, CA209-026, and CA184-104 or received prior treatment with anti-programmed death 1 (PD-1) or anti-programmed death-ligand 1 (PDL1) experimental agents

Prohibited Treatments and/or Restricted Therapies

Ongoing or planned administration of anti-cancer therapies other than those specified in this study
Use of corticosteroids or other immunosuppressive medications

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1428

Study ID:

NCT02066636

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 131 Locations for this study

See Locations Near You

Southern Cancer Center Pc
Mobile Alabama, 36608, United States
Cancer Center Treatment Center of America
Goodyear Arizona, 85338, United States
Arizona Oncology Associates
Phoenix Arizona, 85016, United States
Arizona Oncology Associates
Sedona Arizona, 86336, United States
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
Tucson Arizona, 85704, United States
Comprehensive Blood And Cancer Center
Bakersfield California, 93309, United States
Diablo Valley Oncology
Concord California, 94520, United States
Saint Jude Heritage Medical Group Virginia K Crosson Cancer Center
Fullerton California, 92835, United States
Ucla Hema/Onc-Santa Monica
Los Angeles California, 90095, United States
Pacific Cancer Care
Monterey California, 93940, United States
Sutter Cancer Center
Sacramento California, 95816, United States
Local Institution
San Francisco California, 94117, United States
Central Coast Med Oncology
San Luis Obispo California, 93401, United States
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara California, 93105, United States
Central Coast Med Oncology
Santa Maria California, 93454, United States
Torrance Memorial Medical Center
Torrance California, 90505, United States
Rocky Mountain Cancer Centers
Denver Colorado, 80218, United States
Mountain Blue Cancer Care Center
Golden Colorado, 80401, United States
St. Mary's Hospital Regional Cancer Center
Grand Junction Colorado, 81501, United States
Eastern Ct Hem Onc Assoc
Norwich Connecticut, 06360, United States
Holy Cross Hospital Inc.
Fort Lauderdale Florida, 33308, United States
Florida Cancer Specialists S.
Fort Myers Florida, 33901, United States
Baptist Cancer Institute
Jacksonville Florida, 32207, United States
Local Institution - 0031
Lakeland Florida, 33805, United States
Local Institution - 0038
Miami Florida, 33176, United States
Ocala Oncology Center
Ocala Florida, 34474, United States
Cancer Institute Of Florida
Orlando Florida, 32804, United States
Memorial Cancer Institute
Pemroke Pines Florida, 33028, United States
Local Institution - 0071
Pensacola Florida, 32504, United States
Hematology/Oncology Associates Of The Treasure Coast
Port Saint Lucie Florida, 34952, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Local Institution - 0108
Tampa Florida, 33612, United States
Space Coast Cancer Center
Titusville Florida, 32796, United States
University Cancer Blood Ctr
Athens Georgia, 30607, United States
Piedmont Hospital
Atlanta Georgia, 30318, United States
Central Georgia Cancer Care, Pc
Macon Georgia, 31201, United States
Cancer Treatment Centers Of America
Newnan Georgia, 30265, United States
Summit Cancer Care
Savannah Georgia, 31405, United States
Lewis Hall Singletary Oncology Center
Thomasville Georgia, 31792, United States
Pearlman Cancer Center
Valdosta Georgia, 31602, United States
University Of Illinois Cancer Center
Chicago Illinois, 60612, United States
Illinois Cancer Specialists
Niles Illinois, 60714, United States
Oncology Specialists
Park Ridge Illinois, 60068, United States
Quincy Medical Group
Quincy Illinois, 62301, United States
Local Institution - 0015
Skokie Illinois, 60077, United States
Southern Illinois University School Of Medicine
Springfield Illinois, 62794, United States
Local Institution - 0081
Fort Wayne Indiana, 46804, United States
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Cancer Center Of Kansas
Wichita Kansas, 67214, United States
Norton Cancer Center
Louisville Kentucky, 40202, United States
University Medical Center, Inc
Louisville Kentucky, 40202, United States
West KY Hematology Oncology Group PSC
Paducah Kentucky, 42003, United States
Christus Schumpert Health
Shreveport Louisiana, 71105, United States
Local Institution
Brewer Maine, 04412, United States
Anne Arundel Medical Center
Annapolis Maryland, 21401, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
Walter Reed National Mltry Medical Center
Bethesda Maryland, 20889, United States
Maryland Oncology Hematology, P.A.
Columbia Maryland, 21044, United States
Bay Hematology Oncology
Easton Maryland, 21601, United States
Michigan Cancer Research Consortinum
Ann Arbor Michigan, 48016, United States
Cancer & Hematology Centers Of Western Michigan
Grand Rapids Michigan, 49503, United States
Providence Cancer Center
Southfield Michigan, 48075, United States
Forrest General Cancer Center
Hattiesburg Mississippi, 39401, United States
Jackson Oncology Associates, Pllc
Jackson Mississippi, 39202, United States
North Mississippi Hematology And Oncology Associates, Ltd
Tupelo Mississippi, 38801, United States
University Of Kansas Cancer Center
North Kansas City Missouri, 64116, United States
Mercy Medical Research Institute
Springfield Missouri, 65807, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C.
Lincoln Nebraska, 68510, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
Comprehensive Cancer Center Of Nevada
Las Vegas Nevada, 89119, United States
VA Sierra Nevada Health Care System
Reno Nevada, 89502, United States
Hunterdon Medical Center
Flemington New Jersey, 08822, United States
Atlantic Health System
Summit New Jersey, 07091, United States
Presbyterian Medical Group
Albuquerque New Mexico, 87110, United States
St. Peters Hospital
Albany New York, 12208, United States
Maimonides Medical Center
Brooklyn New York, 11220, United States
Queens Medical Associates
Fresh Meadows New York, 11366, United States
Broome Oncology
Johnson City New York, 13790, United States
Winthrop University Hospital
Mineola New York, 11501, United States
Mount Kisco Medical Group
Mount Kisco New York, 10549, United States
Columbia University Medical Center (Cumc)
New York New York, 10032, United States
Hematology-Oncology Associates Of Rockland
Nyack New York, 10960, United States
Randolph Cancer Center
Asheboro North Carolina, 27203, United States
Southeastern Medical Oncology Center
Goldsboro North Carolina, 27534, United States
Moses Cone Regional Cancer Center
Greensboro North Carolina, 27403, United States
East Carolina University Leo W. Jenkins Cancer Center
Greeville North Carolina, 27834, United States
W.G. Bill Hefner VA Medical Center
Salisbury North Carolina, 28144, United States
Mid Dakota Clinic, Pc
Bismarck North Dakota, 58501, United States
Oncology Hematology Care, Incorporated
Cincinnati Ohio, 45242, United States
Local Institution
Cleveland Ohio, 44195, United States
Zangmeister Cancer Center
Columbus Ohio, 43219, United States
Lehigh Valley Hospital
Allentown Pennsylvania, 18103, United States
St. Luke's University Hospital Bethlehem
Bethlehem Pennsylvania, 18015, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17604, United States
St. Mary Medical Center
Langhorne Pennsylvania, 19047, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
Charleston Hematology Oncology Associates, Pa
Charleston South Carolina, 29414, United States
South Carolina Oncology Associates
Columbia South Carolina, 29210, United States
Greenville Health System
Greenville South Carolina, 29605, United States
Tennessee Oncology, PLLC - SCRI - PPDS
Chattanooga Tennessee, 37404, United States
Cancer Care Of Wnc
Germantown Tennessee, 38138, United States
The Jones Clinic, PC
Germantown Tennessee, 38138, United States
The West Clinic, P.C.
Germantown Tennessee, 38138, United States
Tennessee Oncology, Pllc
Nashville Tennessee, 37203, United States
Henry-Joyce Cancer Center
Nashville Tennessee, 37232, United States
Texas Oncology-Abilene
Abilene Texas, 79606, United States
Texas Oncology - Amarillo
Amarillo Texas, 79106, United States
Texas Oncology
Arlington Texas, 76012, United States
Texas Oncology-Beaumont
Beaumont Texas, 77702, United States
Texas Oncology
Bedford Texas, 76022, United States
Texas Oncology
Dallas Texas, 75230, United States
Texas Oncology
Dallas Texas, 75231, United States
Local Institution - 0067
Dallas Texas, 75246, United States
Texas Oncology
Denton Texas, 76201, United States
The Center For Cancer And Blood Disorders
Fort Worth Texas, 76104, United States
Northwest Cancer Center
Houston Texas, 77090, United States
Texas Oncology
McAllen Texas, 78503, United States
Texas Oncology
Mesquite Texas, 75150, United States
Texas Oncology - Odessa
Midland Texas, 79701, United States
Texas Oncology-Plano East
Plano Texas, 75075, United States
Cancer Care Centers Of South Texas
San Antonio Texas, 78212, United States
Texas Cancer Center - Sherman
Sherman Texas, 75090, United States
Texas Oncology Cancer Care And Research Center
Waco Texas, 76712, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
University Of Virginia Health System.
Charlottesville Virginia, 22908, United States
Shenandoah Oncology
Winchester Virginia, 22601, United States
Local Institution
Calgary Alberta, T2N 4, Canada
Local Institution
Halifax Nova Scotia, B3H 2, Canada
Kingston General Hospital
Kingston Ontario, K7L 2, Canada
Local Institution
Ottawa Ontario, K1H 8, Canada
Local Institution
Toronto Ontario, M5G 2, Canada
Local Institution
Levis Quebec, G6V 3, Canada
Local Institution
Montreal Quebec, H3T 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1428

Study ID:

NCT02066636

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.