Lung Cancer Clinical Trial

A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

Summary

The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).

View Eligibility Criteria

Eligibility Criteria

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

Inclusion Criteria:

Histologically or cytologically documented Squamous or non-Squamous Non-small cell lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following multimodal therapy
Patients must have received pre-study nivolumab for up to 12 months and have 2 consecutive tumor assessments confirming Complete response (CR), Partial response (PR), or Stable disease (SD)
Measurable disease before start of pre-study nivolumab treatment
Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2

Exclusion Criteria:

Carcinomatous meningitis
Untreated, symptomatic Central nervous system (CNS) metastases
Symptomatic interstitial lung disease

Other protocol defined inclusion/exclusion criteria could apply

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

363

Study ID:

NCT02713867

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 125 Locations for this study

See Locations Near You

Local Institution - 0004
Birmingham Alabama, 35205, United States
Local Institution - 0030
Phoenix Arizona, 85016, United States
Local Institution - 0041
Phoenix Arizona, 85016, United States
CBCC Global Research, Inc.
Bakersfield California, 93309, United States
Southern California Permanente Medical Group
Bellflower California, 90706, United States
St Jude Hospital Yorba Linda
Fullerton California, 92835, United States
Local Institution - 0046
Los Angeles California, 90095, United States
Local Institution - 0126
Orange California, 92868, United States
Torrance Health Association
Redondo Beach California, 90227, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
Local Institution - 0010
Santa Barbara California, 93015, United States
Local Institution - 0044
Santa Maria California, 93454, United States
Local Institution - 0130
Vallejo California, 94589, United States
Local Institution - 0017
Denver Colorado, 80218, United States
Local Institution - 0122
Fort Collins Colorado, 80528, United States
Local Institution - 0038
Fort Myers Florida, 33901, United States
Local Institution - 0089
Hollywood Florida, 33021, United States
Local Institution - 0026
Ocala Florida, 34471, United States
Local Institution - 0001
Pensacola Florida, 32504, United States
Local Institution - 0039
Saint Petersburg Florida, 33705, United States
Local Institution - 0008
Athens Georgia, 30607, United States
Local Institution - 0142
Columbus Georgia, 31904, United States
Local Institution - 0121
Marietta Georgia, 30060, United States
Ingalls Health System
Harvey Illinois, 60426, United States
Local Institution - 0098
Niles Illinois, 60714, United States
Local Institution - 0100
Peoria Illinois, 61615, United States
Local Institution - 0143
Urbana Illinois, 61801, United States
Local Institution - 0099
Fort Wayne Indiana, 46485, United States
Local Institution - 0050
Fort Wayne Indiana, 46804, United States
Innova Schar Cancer Institute
Indianapolis Indiana, 46237, United States
Local Institution - 0123
Wichita Kansas, 67214, United States
Local Institution - 0112
Paducah Kentucky, 42003, United States
Mary Bird Perkins Cancer Center
Baton Rouge Louisiana, 70809, United States
Local Institution - 0137
New Orleans Louisiana, 70121, United States
Local Institution - 0109
Brewer Maine, 04412, United States
Local Institution - 0042
Bethesda Maryland, 20817, United States
Local Institution - 0125
Springfield Massachusetts, 01107, United States
Local Institution - 0136
Southfield Michigan, 48075, United States
Local Institution - 0120
Minneapolis Minnesota, 55404, United States
Local Institution - 0116
Tupelo Mississippi, 38801, United States
Mercy Medical Research Institute
Springfield Missouri, 65806, United States
Local Institution - 0014
Omaha Nebraska, 68130, United States
Local Institution - 0141
Lebanon New Hampshire, 03756, United States
Local Institution - 0035
Albany New York, 12206, United States
Local Institution - 0013
Johnson City New York, 13790, United States
Local Institution - 0127
Pinehurst North Carolina, 28374, United States
Hematology And Oncology Associates
Canton Ohio, 44708, United States
Local Institution - 0037
Cincinnati Ohio, 45242, United States
Local Institution - 0132
Cincinnati Ohio, 45242, United States
MetroHealth Cancer Care Center
Cleveland Ohio, 44109, United States
Local Institution - 0129
Massillon Ohio, 44646, United States
Hematology Oncology Consultants, Pc
Medford Oregon, 97504, United States
Local Institution - 0005
Pittsburgh Pennsylvania, 15224, United States
Local Institution - 0020
Charleston South Carolina, 29414, United States
Local Institution - 0124
Sioux Falls South Dakota, 57105, United States
Jones Clinic PC
Germantown Tennessee, 38138, United States
Local Institution - 0036
Nashville Tennessee, 37203, United States
Local Institution - 0023
Abilene Texas, 79606, United States
Texas Oncology - Amarillo
Amarillo Texas, 79106, United States
Local Institution - 0011
Dallas Texas, 75230, United States
Local Institution - 0022
Dallas Texas, 75231, United States
Texas Oncology, P.A.
Denton Texas, 76210, United States
Texas Oncology, P.A.
El Paso Texas, 79902, United States
Local Institution - 0025
Flower Mound Texas, 75028, United States
Texas Oncology, P.A.
Houston Texas, 77024, United States
Texas Oncology, P.A.
Longview Texas, 75601, United States
Local Institution - 0119
Midland Texas, 79701, United States
Texas Oncology, P.A.
Plano Texas, 75093, United States
Texas Oncology, P.A.
San Antonio Texas, 78212, United States
Texas Oncology, P.A.
Sherman Texas, 75090, United States
Texas Oncology, P.A.
Sugar Land Texas, 77479, United States
Local Institution - 0034
Wichita Falls Texas, 76310, United States
Innova Schar Cancer Institute
Falls Church Virginia, 22042, United States
Shenandoah Oncology
Winchester Virginia, 22601, United States
Cancer Care Northwest
Spokane Valley Washington, 99216, United States
Local Institution - 0031
Vancouver Washington, 98684, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima Washington, 98902, United States
Local Institution - 0052
St. Leonards New South Wales, 2065, Australia
Local Institution - 0118
Waratah New South Wales, 2298, Australia
Local Institution - 0117
Westmead, New South Wales, 2145, Australia
Local Institution - 0093
Woolloongabba Queensland, 4102, Australia
Local Institution - 0054
Bedford Park South Australia, 5042, Australia
Local Institution - 0056
Elizabeth Vale South Australia, 5112, Australia
Local Institution - 0055
Kurralta Park South Australia, 5037, Australia
Local Institution - 0057
Hobart Tasmania, 7000, Australia
Local Institution - 0053
Heidelberg Victoria, 3084, Australia
Local Institution - 0058
Murdoch Western Australia, 6150, Australia
Local Institution
Wien , 1090, Austria
Local Institution - 0059
Newmarket Ontario, L3Y 2, Canada
Local Institution - 0146
Laval Quebec, H7M 3, Canada
Local Institution - 0145
Montreal Quebec, H4J 1, Canada
Local Institution - 0060
St. Jerome Quebec, J7Z 5, Canada
Local Institution
Quebec , GIJ 1, Canada
Local Institution - 0081
Angers , 49000, France
Local Institution - 0105
Angers , 49000, France
Local Institution - 0080
Bayonne , 64109, France
Local Institution - 0076
Clermont-Ferrand Cedex 01 , 63003, France
Local Institution - 0077
Le Mans , 72000, France
Local Institution - 0072
Mulhouse , 68100, France
Local Institution - 0078
Nimes , 30029, France
Local Institution - 0095
Paris , 75005, France
Local Institution - 0083
Paris , 75014, France
Local Institution
Pontoise , 95300, France
Local Institution - 0075
Suresnes Cedex , 92 15, France
Local Institution - 0079
Tours , 37044, France
Local Institution - 0097
Vandoeuvre-les-Nancy , 54519, France
Local Institution - 0096
Villefranche-sur-Saone Cedex , 69655, France
Local Institution
Bad Berka , 99437, Germany
Local Institution - 0073
Berlin , 13353, Germany
Local Institution - 0063
Dresden , 01307, Germany
Local Institution
Freiburg , 79106, Germany
Local Institution - 0102
Gauting , 82131, Germany
Local Institution - 0062
Greifenstein , 35753, Germany
Local Institution - 0061
Hamburg , 20251, Germany
Local Institution - 0113
Hannover , 30625, Germany
Local Institution - 0064
Kassel , 34125, Germany
Local Institution - 0106
Kiel , 24105, Germany
Local Institution - 0065
Leipzig , 04357, Germany
Local Institution
Lostau , 39291, Germany
Local Institution - 0066
Moers , 47447, Germany
Local Institution - 0067
Nürnberg , 90419, Germany
Local Institution - 0086
Localita San Filippo Lucca , 55100, Italy
Local Institution - 0085
Monza , 20900, Italy
Local Institution - 0088
Napoli , 80131, Italy
Local Institution - 0087
Roma , 00128, Italy
Local Institution - 0069
Barcelona , 08208, Spain
Local Institution - 0104
El Palmar , 30120, Spain
Local Institution - 0068
Las Palmas de Gran Canaria , 35016, Spain
Local Institution - 0070
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

363

Study ID:

NCT02713867

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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