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).
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
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There are 125 Locations for this study
Birmingham Alabama, 35205, United States
Phoenix Arizona, 85016, United States
Phoenix Arizona, 85016, United States
Bakersfield California, 93309, United States
Bellflower California, 90706, United States
Fullerton California, 92835, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Redondo Beach California, 90227, United States
San Diego California, 92123, United States
Santa Barbara California, 93015, United States
Santa Maria California, 93454, United States
Vallejo California, 94589, United States
Denver Colorado, 80218, United States
Fort Collins Colorado, 80528, United States
Fort Myers Florida, 33901, United States
Hollywood Florida, 33021, United States
Ocala Florida, 34471, United States
Pensacola Florida, 32504, United States
Saint Petersburg Florida, 33705, United States
Athens Georgia, 30607, United States
Columbus Georgia, 31904, United States
Marietta Georgia, 30060, United States
Harvey Illinois, 60426, United States
Niles Illinois, 60714, United States
Peoria Illinois, 61615, United States
Urbana Illinois, 61801, United States
Fort Wayne Indiana, 46485, United States
Fort Wayne Indiana, 46804, United States
Indianapolis Indiana, 46237, United States
Wichita Kansas, 67214, United States
Paducah Kentucky, 42003, United States
Baton Rouge Louisiana, 70809, United States
New Orleans Louisiana, 70121, United States
Brewer Maine, 04412, United States
Bethesda Maryland, 20817, United States
Springfield Massachusetts, 01107, United States
Southfield Michigan, 48075, United States
Minneapolis Minnesota, 55404, United States
Tupelo Mississippi, 38801, United States
Springfield Missouri, 65806, United States
Omaha Nebraska, 68130, United States
Lebanon New Hampshire, 03756, United States
Albany New York, 12206, United States
Johnson City New York, 13790, United States
Pinehurst North Carolina, 28374, United States
Canton Ohio, 44708, United States
Cincinnati Ohio, 45242, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44109, United States
Massillon Ohio, 44646, United States
Medford Oregon, 97504, United States
Pittsburgh Pennsylvania, 15224, United States
Charleston South Carolina, 29414, United States
Sioux Falls South Dakota, 57105, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
Abilene Texas, 79606, United States
Amarillo Texas, 79106, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Denton Texas, 76210, United States
El Paso Texas, 79902, United States
Flower Mound Texas, 75028, United States
Houston Texas, 77024, United States
Longview Texas, 75601, United States
Midland Texas, 79701, United States
Plano Texas, 75093, United States
San Antonio Texas, 78212, United States
Sherman Texas, 75090, United States
Sugar Land Texas, 77479, United States
Wichita Falls Texas, 76310, United States
Falls Church Virginia, 22042, United States
Winchester Virginia, 22601, United States
Spokane Valley Washington, 99216, United States
Vancouver Washington, 98684, United States
Yakima Washington, 98902, United States
St. Leonards New South Wales, 2065, Australia
Waratah New South Wales, 2298, Australia
Westmead, New South Wales, 2145, Australia
Woolloongabba Queensland, 4102, Australia
Bedford Park South Australia, 5042, Australia
Elizabeth Vale South Australia, 5112, Australia
Kurralta Park South Australia, 5037, Australia
Hobart Tasmania, 7000, Australia
Heidelberg Victoria, 3084, Australia
Murdoch Western Australia, 6150, Australia
Wien , 1090, Austria
Newmarket Ontario, L3Y 2, Canada
Laval Quebec, H7M 3, Canada
Montreal Quebec, H4J 1, Canada
St. Jerome Quebec, J7Z 5, Canada
Quebec , GIJ 1, Canada
Angers , 49000, France
Angers , 49000, France
Bayonne , 64109, France
Clermont-Ferrand Cedex 01 , 63003, France
Le Mans , 72000, France
Mulhouse , 68100, France
Nimes , 30029, France
Paris , 75005, France
Paris , 75014, France
Pontoise , 95300, France
Suresnes Cedex , 92 15, France
Tours , 37044, France
Vandoeuvre-les-Nancy , 54519, France
Villefranche-sur-Saone Cedex , 69655, France
Bad Berka , 99437, Germany
Berlin , 13353, Germany
Dresden , 01307, Germany
Freiburg , 79106, Germany
Gauting , 82131, Germany
Greifenstein , 35753, Germany
Hamburg , 20251, Germany
Hannover , 30625, Germany
Kassel , 34125, Germany
Kiel , 24105, Germany
Leipzig , 04357, Germany
Lostau , 39291, Germany
Moers , 47447, Germany
Nürnberg , 90419, Germany
Localita San Filippo Lucca , 55100, Italy
Monza , 20900, Italy
Napoli , 80131, Italy
Roma , 00128, Italy
Barcelona , 08208, Spain
El Palmar , 30120, Spain
Las Palmas de Gran Canaria , 35016, Spain
Sevilla , 41013, Spain
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