Clinical trial NCT02041533: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Official title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stage IV or Recurrent Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2014-01-22
Enrollment: 541
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1
* Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria
* PD-L1+ on immunohistochemistry testing performed by central lab
* Men and women, ages ≥ 18 years of age

Exclusion Criteria:

* Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy
* Known anaplastic lymphoma kinase (ALK) translocations
* Untreated central nervous system (CNS) metastases
* Previous malignancies
* Active, known or suspected autoimmune disease

Primary outcomes:
measure: Progression-Free Survival in Participants With PD-L1 Expression >= 5%
timeFrame: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Secondary outcomes:
measure: Progression-Free Survival in All Randomized Participants
timeFrame: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
measure: Overall Survival in Participants With PD-L1 Expression >= 5%
timeFrame: From date of randomization to date of death (up to approximately 89 months)
measure: Overall Survival in All Randomized Participants
timeFrame: From date of randomization to date of death (up to approximately 89 months)
measure: Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%
timeFrame: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)
measure: Disease-related Symptom Improvement Rate by Week 12
timeFrame: From date of randomization to week 12
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center, Inc.
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Tucson
country: United States
facility: Local Institution - 0034
state: Arizona
city: Stanford
country: United States
facility: Local Institution - 0016
state: California
city: Aurora
country: United States
facility: University Of Colorado Hosp
state: Colorado
city: New Haven
country: United States
facility: Local Institution - 0020
state: Connecticut
city: Miami
country: United States
facility: Local Institution - 0030
state: Florida
city: Ocala
country: United States
facility: Local Institution - 0033
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0010
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Center, P.C.
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0037
state: Illinois
city: Lexington
country: United States
facility: Local Institution - 0014
state: Kentucky
city: Marrero
country: United States
facility: Crescent City Research Consortium, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Local Institution - 0024
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0036
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0070
state: Massachusetts
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Local Institution - 0009
state: New York
city: New York
country: United States
facility: Local Institution - 0005
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina At Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Local Institution - 0003
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution - 0012
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 0027
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Allentown
country: United States
facility: Local Institution - 0007
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 0054
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 0002
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0018
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0011
state: South Carolina
city: Greenville
country: United States
facility: Local Institution - 0038
state: South Carolina
city: Nashville
country: United States
facility: Local Institution - 0008
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 0006
state: Texas
city: Houston
country: United States
facility: Local Institution - 0023
state: Texas
city: San Antonio
country: United States
facility: Cancer Centers of South Texas
state: Texas
city: Yakima
country: United States
facility: Local Institution - 0029
state: Washington
city: Berazategui
country: Argentina
facility: Local Institution - 0051
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution - 0049
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aire
country: Argentina
facility: Local Institution - 0052
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Local Institution - 0048
city: Cordoba
country: Argentina
facility: Local Institution - 0050
city: Camperdown
country: Australia
facility: Local Institution - 0090
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0091
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Local Institution - 0071
state: South Australia
city: Fitzroy
country: Australia
facility: Local Institution - 0072
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution - 0104
state: Victoria
city: Wels
country: Austria
facility: Local Institution - 0088
city: Wien
country: Austria
facility: Local Institution - 0087
city: Brussels
country: Belgium
facility: Local Institution - 0044
city: Edegem
country: Belgium
facility: Local Institution - 0055
city: Gent
country: Belgium
facility: Local Institution - 0056
city: Leuven
country: Belgium
facility: Local Institution - 0062
city: Ijui
country: Brazil
facility: Local Institution - 0134
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution - 0133
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Local Institution - 0135
state: Sao Paulo
city: Calgary
country: Canada
facility: Local Institution - 0086
state: Alberta
city: Hamilton
country: Canada
facility: Local Institution - 0115
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0113
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0110
state: Quebec
city: Rimouski
country: Canada
facility: Local Institution - 0109
state: Quebec
city: Olomouc
country: Czechia
facility: Local Institution - 0059
city: Ostrava - Poruba
country: Czechia
facility: Local Institution - 0061
city: Praha 8
country: Czechia
facility: Local Institution - 0058
city: Usti nad Labem
country: Czechia
facility: Local Institution - 0060
city: Helsinki
country: Finland
facility: Local Institution - 0120
city: Tampere
country: Finland
facility: Local Institution - 0119
city: Vaasa
country: Finland
facility: Local Institution - 0118
city: Caen
country: France
facility: Local Institution - 0123
city: Lille
country: France
facility: Local Institution - 0105
city: Marseille Cedex 20
country: France
facility: Local Institution - 0102
city: Pontoise Cedex
country: France
facility: Local Institution - 0167
city: Rennes Cedex 9
country: France
facility: Local Institution - 0100
city: Strasbourg
country: France
facility: Local Institution - 0140
city: Bamberg
country: Germany
facility: Local Institution - 0074
city: Grosshansdorf
country: Germany
facility: Local Institution - 0065
city: Heidelberg
country: Germany
facility: Local Institution - 0064
city: Koeln
country: Germany
facility: Local Institution - 0063
city: Stuttgart
country: Germany
facility: Local Institution - 0066
city: Wiesbaden
country: Germany
facility: Local Institution - 0092
city: Heraklion
country: Greece
facility: Local Institution - 0073
state: Creta
city: Athens
country: Greece
facility: Local Institution - 0075
city: Budapest
country: Hungary
facility: Local Institution - 0126
city: Debrecen
country: Hungary
facility: Local Institution - 0116
city: Matrahaza
country: Hungary
facility: Local Institution - 0094
city: Avellino
country: Italy
facility: Local Institution - 0084
city: Livorno
country: Italy
facility: Local Institution - 0079
city: Milano
country: Italy
facility: Local Institution - 0143
city: Napoli
country: Italy
facility: Local Institution - 0142
city: Perugia
country: Italy
facility: Local Institution - 0083
city: Terni
country: Italy
facility: Local Institution - 0082
city: Nagoya-shi
country: Japan
facility: Local Institution - 0161
state: Aichi
city: Nagoya
country: Japan
facility: Local Institution - 0146
state: Aichi
city: Matsuyama-shi
country: Japan
facility: Local Institution - 0148
state: Ehime
city: Kobe City
country: Japan
facility: Local Institution - 0153
state: Hyogo
city: Natori-shi
country: Japan
facility: Local Institution - 0144
state: Miyagi
city: Niigata-shi
country: Japan
facility: Local Institution - 0151
state: Niigata
city: Habikino-shi
country: Japan
facility: Local Institution - 0166
state: Osaka
city: Miyakojima-ku
country: Japan
facility: Local Institution - 0147
state: Osaka
city: Osaka-sayama
country: Japan
facility: Local Institution - 0145
state: Osaka
city: Sakai
country: Japan
facility: Local Institution - 0152
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Local Institution - 0150
state: Saitama
city: Sunto-gun
country: Japan
facility: Local Institution - 0149
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Local Institution - 0154
state: Tokyo
city: Akashi, Hyogo
country: Japan
facility: Local Institution - 0159
city: Ota, Gunma
country: Japan
facility: Local Institution - 0162
city: Sapporo, Hokkaido
country: Japan
facility: Local Institution - 0165
city: Tokyo
country: Japan
facility: Local Institution - 0160
city: Wakayama
country: Japan
facility: Local Institution - 0158
city: Gangnam-gu
country: Korea, Republic of
facility: Local Institution - 0155
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0164
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0163
city: Mexico
country: Mexico
facility: Local Institution - 0117
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution - 0122
state: Jalisco
city: Merida
country: Mexico
facility: Local Institution - 0124
state: Yucatan
city: Amsterdam
country: Netherlands
facility: Local Institution - 0045
city: Groningen
country: Netherlands
facility: Local Institution - 0057
city: Rotterdam
country: Netherlands
facility: Local Institution - 0046
city: Bydgoszcz
country: Poland
facility: Local Institution - 0114
city: Krakow
country: Poland
facility: Local Institution - 0131
city: Lodz
country: Poland
facility: Local Institution - 0139
city: Warszawa
country: Poland
facility: Local Institution - 0089
city: Wodzislaw Slaski
country: Poland
facility: Local Institution - 0093
city: Cluj Napoca
country: Romania
facility: Local Institution - 0068
city: Cluj-napoca
country: Romania
facility: Local Institution - 0067
city: Ploiesti
country: Romania
facility: Local Institution - 0069
city: Barcelona
country: Spain
facility: Local Institution - 0040
city: Las Palmas De Gran Canaria
country: Spain
facility: Local Institution - 0041
city: Madrid
country: Spain
facility: Local Institution - 0047
city: Malaga
country: Spain
facility: Local Institution - 0042
city: Sevilla
country: Spain
facility: Local Institution - 0039
city: Valencia
country: Spain
facility: Local Institution - 0043
city: Stockholm
country: Sweden
facility: Local Institution - 0127
city: Uppsala
country: Sweden
facility: Local Institution - 0125
city: Chur
country: Switzerland
facility: Local Institution - 0076
city: Lausanne
country: Switzerland
facility: Local Institution - 0077
city: Zuerich
country: Switzerland
facility: Local Institution - 0078
city: Taipei
country: Taiwan
facility: Local Institution - 0157
city: Kayseri
country: Turkey
facility: Local Institution - 0130
city: London
country: United Kingdom
facility: Local Institution - 0098
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution - 0097
state: Greater Manchester
city: Leeds
country: United Kingdom
facility: Local Institution - 0053
state: Yorkshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.