Clinical trial NCT02998528: A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Official title: Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2016-12-20
Enrollment: 505
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 neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.

This study has multiple primary endpoints.


Eligibility criteria: Inclusion Criteria:

* Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
* Lung function capacity capable of tolerating the proposed lung surgery
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Available tissue of primary lung tumor

Exclusion Criteria:

* Presence of locally advanced, inoperable or metastatic disease
* Participants with active, known or suspected autoimmune disease
* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Event-Free Survival (EFS)
timeFrame: From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
measure: Pathologic Complete Response (pCR) Rate
timeFrame: From randomization up to a median of 30 months after randomization.
Secondary outcomes:
measure: Major Pathologic Response (MPR) Rate
timeFrame: From randomization up to a median of 30 months after randomization.
measure: Overall Survival (OS)
timeFrame: From randomization to the date of death
measure: Time to Death or Distant Metastases (TTDM)
timeFrame: From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to a median of 30 months)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Local Institution - 0121
state: Arizona
city: Los Angeles
country: United States
facility: Local Institution - 0081
state: California
city: Denver
country: United States
facility: Local Institution - 0025
state: Colorado
city: Plainville
country: United States
facility: Local Institution - 0007
state: Connecticut
city: Hollywood
country: United States
facility: Local Institution - 0173
state: Florida
city: Miami
country: United States
facility: Local Institution - 0136
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0054
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Vero Beach
country: United States
facility: Indian River Medical Center
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Center, P.C.
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0015
state: Illinois
city: Chicago
country: United States
facility: Local Institution - 0002
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Fort Wayne
country: United States
facility: Local Institution - 0171
state: Indiana
city: Lexington
country: United States
facility: Local Institution - 0170
state: Kentucky
city: Louisville
country: United States
facility: Local Institution - 0186
state: Kentucky
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Local Institution - 0151
state: Maryland
city: Baltimore
country: United States
facility: Local Institution - 0001
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0008
state: Massachusetts
city: Fairhaven
country: United States
facility: Southcoast Center For Cancer
state: Massachusetts
city: Newton
country: United States
facility: Local Institution - 0006
state: Massachusetts
city: Detroit
country: United States
facility: Local Institution - 0012
state: Michigan
city: Hattiesburg
country: United States
facility: Local Institution - 0090
state: Mississippi
city: Billings
country: United States
facility: St Vincent Frontier Cancer Center
state: Montana
city: Las Vegas
country: United States
facility: Local Institution - 0032
state: Nevada
city: Hackensack
country: United States
facility: Local Institution - 0009
state: New Jersey
city: Westwood
country: United States
facility: Valley Hospital Luckow Pavili
state: New Jersey
city: Albany
country: United States
facility: Local Institution - 0027
state: New York
city: New York
country: United States
facility: Local Institution - 0011
state: New York
city: High Point
country: United States
facility: Local Institution - 0140
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Zanesville
country: United States
facility: Local Institution - 0149
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente
state: Oregon
city: Portland
country: United States
facility: Local Institution - 0139
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution - 0010
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0018
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0013
state: South Carolina
city: Charleston
country: United States
facility: Local Institution - 0021
state: South Carolina
city: Greenville
country: United States
facility: Local Institution - 0146
state: South Carolina
city: Nashville
country: United States
facility: Local Institution - 0092
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0005
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 0035
state: Texas
city: Bedford
country: United States
facility: Texas Oncology
state: Texas
city: Fort Bliss
country: United States
facility: Local Institution - 0153
state: Texas
city: Houston
country: United States
facility: Local Institution - 0106
state: Texas
city: Lubbock
country: United States
facility: Southwest Cancer Center
state: Texas
city: Sherman
country: United States
facility: Texas Cancer Center - Sherman
state: Texas
city: Tyler
country: United States
facility: Local Institution - 0143
state: Texas
city: Waco
country: United States
facility: Local Institution - 0026
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Saint George
country: United States
facility: Southwest Regional Cancer Clinic
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 0003
state: Utah
city: Burlington
country: United States
facility: Local Institution - 0135
state: Vermont
city: Fairfax
country: United States
facility: Local Institution - 0125
state: Virginia
city: Fredericksburg
country: United States
facility: Local Institution - 0198
state: Virginia
city: Capital Federal
country: Argentina
facility: Local Institution - 0022
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aire
country: Argentina
facility: Local Institution - 0023
state: Buenos Aires
city: Brasilia
country: Brazil
facility: Local Institution - 0079
state: Distrito Federal
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0077
state: Minas Gerais
city: Ijui
country: Brazil
facility: Local Institution - 0076
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0073
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Fundacao Pio Xii Hosp Cancer De Barretos
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0075
city: Gatineau
country: Canada
facility: Local Institution - 0095
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0138
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0017
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Local Institution - 0052
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution - 0016
state: Saskatchewan
city: Beijing
country: China
facility: Local Institution - 0161
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0156
state: Beijing
city: Guangzhou
country: China
facility: Local Institution - 0190
state: Guangdong
city: Changsha
country: China
facility: Local Institution - 0192
state: Hunan
city: Changsha
country: China
facility: Local Institution - 0175
state: Hunan
city: Changsha
country: China
facility: Local Institution - 0193
state: Hunan
city: Nanchang
country: China
facility: Local Institution - 0179
state: Jiangxi
city: Nanchang
country: China
facility: Local Institution - 0166
state: Jiangxi
city: Changchun
country: China
facility: Local Institution
state: Jilin
city: XiAn
country: China
facility: Local Institution - 0159
state: Shan1xi
city: Xian
country: China
facility: Local Institution - 0180
state: Shan3xi
city: Shanghai
country: China
facility: Local Institution - 0160
state: Shanghai
city: Chengdu
country: China
facility: Local Institution - 0178
state: Sichuan
city: Tianjin
country: China
facility: Local Institution - 0163
state: Tianjin
city: Hangzhou
country: China
facility: Local Institution - 0189
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0183
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0182
state: Zhejiang
city: Shanghai
country: China
facility: Local Institution - 0165
city: Marseille Cedex 20
country: France
facility: Local Institution - 0059
city: Paris Cedex 5
country: France
facility: Local Institution - 0112
city: Paris
country: France
facility: Local Institution - 0060
city: Pierre Benite Cedax
country: France
facility: Local Institution - 0064
city: Rennes Cedex 9
country: France
facility: Local Institution - 0061
city: Strasbourg
country: France
facility: Local Institution - 0113
city: Toulouse
country: France
facility: Local Institution - 0058
city: Tours Cedex 09
country: France
facility: Local Institution - 0062
city: Athens
country: Greece
facility: Local Institution - 0019
city: Thessaloniki
country: Greece
facility: Local Institution - 0122
city: Budapest
country: Hungary
facility: Local Institution
city: Szekesfehervar
country: Hungary
facility: Local Institution
city: Bari
country: Italy
facility: Local Institution - 0068
city: Genova
country: Italy
facility: Local Institution - 0080
city: Perugia
country: Italy
facility: Local Institution - 0070
city: Ravenna
country: Italy
facility: Local Institution - 0066
city: Roma
country: Italy
facility: Local Institution - 0067
city: Nagoya-shi
country: Japan
facility: Local Institution - 0131
state: Aichi
city: Kashiwa-shi
country: Japan
facility: Local Institution - 0118
state: Chiba
city: Kitakyushu-shi
country: Japan
facility: Local Institution - 0111
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Local Institution - 0110
state: Fukushima
city: Hiroshima-Shi
country: Japan
facility: Local Institution - 0109
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Local Institution - 0147
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Local Institution - 0133
state: Hyogo
city: Yokohama-shi
country: Japan
facility: Local Institution - 0123
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Local Institution - 0148
state: Miyagi
city: Osaka-shi
country: Japan
facility: Local Institution - 0127
state: Osaka
city: Sakai-shi
country: Japan
facility: Local Institution - 0119
state: Osaka
city: Sunto-gun
country: Japan
facility: Local Institution - 0132
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0126
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0120
state: Tokyo
city: Osaka
country: Japan
facility: Local Institution - 0108
city: Tokyo
country: Japan
facility: Local Institution - 0124
city: Busan
country: Korea, Republic of
facility: Local Institution - 0097
city: Hwasun
country: Korea, Republic of
facility: Local Institution - 0098
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0105
city: Amsterdam
country: Netherlands
facility: Local Institution - 0042
city: Groningen
country: Netherlands
facility: Local Institution - 0043
city: Craiova
country: Romania
facility: Local Institution - 0050
city: Romania
country: Romania
facility: Local Institution - 0051
city: Sector 2
country: Romania
facility: Local Institution - 0069
city: Barcelona
country: Spain
facility: Local Institution - 0028
city: Madrid
country: Spain
facility: Local Institution - 0029
city: Majadahonda - Madrid
country: Spain
facility: Local Institution - 0031
city: New Taipei City
country: Taiwan
facility: Local Institution - 0102
city: Taichung
country: Taiwan
facility: Local Institution - 0107
city: Taipei
country: Taiwan
facility: Local Institution - 0099
city: Taipei
country: Taiwan
facility: Local Institution - 0100
city: Adana
country: Turkey
facility: Local Institution - 0093
city: Ankara
country: Turkey
facility: Local Institution - 0084
city: Istanbul
country: Turkey
facility: Local Institution - 0115
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.