Clinical trial NCT02481830: Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
Official title: An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2015-06-25
Enrollment: 569
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 compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed small cell lung cancer (SCLC)
* Subjects with either limited or extensive disease stage at the initial diagnosis
* Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of limited or extensive disease stage SCLC
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Untreated or symptomatic central nervous system (CNS) metastases
* Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
* Inadequate hematologic or hepatic function

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From randomization to the date of first documented tumor progression, or death due to any cause. Tumor response assessed every 6 weeks from first dose until week 30, and every 12 weeks (Up to approximately 80 months)
measure: Objective Response Rate (ORR)
timeFrame: From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 80 months)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Local Institution - 0065
state: Arkansas
city: New Haven
country: United States
facility: Local Institution - 0024
state: Connecticut
city: Atlanta
country: United States
facility: Local Institution - 0018
state: Georgia
city: Saint Louis
country: United States
facility: Local Institution - 0056
state: Missouri
city: Lincoln
country: United States
facility: Local Institution - 0088
state: Nebraska
city: Johnson City
country: United States
facility: Local Institution - 0173
state: New York
city: Durham
country: United States
facility: Local Institution - 0001
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution - 0090
state: Ohio
city: Bethlehem
country: United States
facility: Local Institution - 0002
state: Pennsylvania
city: Lancaster
country: United States
facility: Local Institution - 0057
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 0053
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution - 0089
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0009
state: Tennessee
city: Kennewick
country: United States
facility: Local Institution - 0070
state: Washington
city: Waratah
country: Australia
facility: Local Institution - 0102
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0030
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Local Institution - 0031
state: South Australia
city: Kurralta Park
country: Australia
facility: Local Institution - 0103
state: South Australia
city: Perth
country: Australia
facility: Local Institution - 0028
state: Western Australia
city: Murdoch
country: Australia
facility: Local Institution - 0027
city: Graz
country: Austria
facility: Local Institution - 0085
city: Wels
country: Austria
facility: Local Institution - 0084
city: Wien
country: Austria
facility: Local Institution - 0086
city: Bruxelles
country: Belgium
facility: Local Institution - 0013
city: Edegem
country: Belgium
facility: Local Institution - 0012
city: Leuven
country: Belgium
facility: Local Institution - 0011
city: Yvoir
country: Belgium
facility: Local Institution - 0010
city: Ijui
country: Brazil
facility: Local Institution - 0095
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0094
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Local Institution - 0093
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution - 0099
city: Recoleta
country: Chile
facility: Local Institution - 0025
state: Santiago De Chile
city: Beijing
country: China
facility: Local Institution - 0200
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0199
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0188
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0190
state: Beijing
city: Guanzhou
country: China
facility: Local Institution - 0197
state: Guangdong
city: Zhengzhou
country: China
facility: Local Institution - 0189
state: Henan
city: Nanjing
country: China
facility: Local Institution - 0194
state: Jiangsu
city: Changchun
country: China
facility: Local Institution - 0187
state: Jilin
city: Xian
country: China
facility: Local Institution - 0186
state: Shaanxi
city: Shanghai
country: China
facility: Local Institution - 0181
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0185
state: Shanghai
city: Urumqi
country: China
facility: Local Institution - 0202
state: Xinjiang
city: Hangzhou
country: China
facility: Local Institution - 0183
state: Zhejiang
city: Beijing
country: China
facility: Local Institution - 0201
city: Guangzhou
country: China
facility: Local Institution - 0198
city: Hangzhou
country: China
facility: Local Institution - 0182
city: Shanghai
country: China
facility: Local Institution - 0192
city: Brno
country: Czechia
facility: Local Institution - 0069
city: Brno
country: Czechia
facility: Local Institution - 0067
city: Olomouc
country: Czechia
facility: Local Institution - 0068
city: Praha 4
country: Czechia
facility: Local Institution - 0066
city: Copenhagen
country: Denmark
facility: Local Institution - 0106
city: Herlev
country: Denmark
facility: Local Institution - 0098
city: Odense
country: Denmark
facility: Local Institution - 0100
city: Brest
country: France
facility: Local Institution - 0134
city: Lille Cedex
country: France
facility: Local Institution - 0116
city: Paris Cedex 14
country: France
facility: Local Institution - 0118
city: Pringy Cedex
country: France
facility: Local Institution - 0131
city: Reims
country: France
facility: Local Institution - 0132
city: Toulon Cedex
country: France
facility: Local Institution - 0117
city: Bamberg
country: Germany
facility: Local Institution - 0061
city: Berlin
country: Germany
facility: Local Institution - 0055
city: Essen
country: Germany
facility: Local Institution - 0047
city: Frankfurt am Main
country: Germany
facility: Local Institution - 0071
city: Gera
country: Germany
facility: Local Institution - 0060
city: Gerlingen
country: Germany
facility: Local Institution - 0019
city: Grosshansdorf
country: Germany
facility: Local Institution - 0021
city: Halle (saale)
country: Germany
facility: Local Institution - 0058
city: Hamburg
country: Germany
facility: Local Institution - 0059
city: Heidelberg
country: Germany
facility: Local Institution - 0020
city: Immenstadt
country: Germany
facility: Local Institution - 0046
city: Koeln
country: Germany
facility: Local Institution - 0023
city: Muenchen
country: Germany
facility: Local Institution - 0022
city: Oberhausen
country: Germany
facility: Local Institution - 0054
city: Regensburg
country: Germany
facility: Local Institution - 0064
city: Heraklion
country: Greece
facility: Local Institution - 0063
state: Creta
city: Athens
country: Greece
facility: Local Institution - 0062
city: Thessaloniki
country: Greece
facility: Local Institution - 0097
city: Budapest
country: Hungary
facility: Local Institution - 0112
city: Budapest
country: Hungary
facility: Local Institution - 0110
city: Budapest
country: Hungary
facility: Local Institution - 0150
city: Beer Sheva
country: Israel
facility: Local Institution - 0139
city: Kfar Saba
country: Israel
facility: Local Institution - 0138
city: Ramat -Gan
country: Israel
facility: Local Institution - 0136
city: Safed
country: Israel
facility: Local Institution - 0166
city: Bologna
country: Italy
facility: Local Institution - 0081
city: Livorno
country: Italy
facility: Local Institution - 0073
city: Lucca
country: Italy
facility: Local Institution - 0108
city: Meldola
country: Italy
facility: Local Institution - 0077
city: Milano
country: Italy
facility: Local Institution - 0078
city: Monza
country: Italy
facility: Local Institution - 0080
city: Rimini
country: Italy
facility: Local Institution - 0107
city: Roma
country: Italy
facility: Local Institution - 0079
city: Nagoya-shi
country: Japan
facility: Local Institution - 0159
state: Aichi
city: Nagoya
country: Japan
facility: Local Institution - 0169
state: Aichi
city: Kashiwa
country: Japan
facility: Local Institution - 0196
state: Chiba
city: Matsuyama
country: Japan
facility: Local Institution - 0155
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Local Institution - 0153
state: Fukuoka
city: Akashi-shi
country: Japan
facility: Local Institution - 0168
state: Hyogo
city: Kobe
country: Japan
facility: Local Institution - 0163
state: Hyogo
city: Natori-shi
country: Japan
facility: Local Institution - 0164
state: Miyagi
city: Niigata-shi
country: Japan
facility: Local Institution - 0161
state: Niigata
city: Habikino-shi
country: Japan
facility: Local Institution - 0171
state: Osaka
city: Hirakata-shi
country: Japan
facility: Local Institution - 0175
state: Osaka
city: Osaka-sayama
country: Japan
facility: Local Institution - 0151
state: Osaka
city: Osaka-shi
country: Japan
facility: Local Institution - 0165
state: Osaka
city: Sakai
country: Japan
facility: Local Institution - 0160
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Local Institution - 0162
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0176
state: Tokyo
city: Chuo-ku
country: Japan
facility: Local Institution - 0170
state: Tokyo
city: Chuo-ku
country: Japan
facility: Local Institution - 0174
state: Tokyo
city: Wakayama-Shi
country: Japan
facility: Local Institution - 0152
state: Wakayama
city: Tokyo
country: Japan
facility: Local Institution - 0154
city: Suwon
country: Korea, Republic of
facility: Local Institution - 0145
state: Gyeonggi-do
city: Cheongju-si
country: Korea, Republic of
facility: Local Institution - 0146
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0147
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0148
city: Bergen
country: Norway
facility: Local Institution - 0096
city: Oslo
country: Norway
facility: Local Institution - 0072
city: Elblag
country: Poland
facility: Local Institution - 0044
city: Gdansk
country: Poland
facility: Local Institution - 0041
city: Krakow
country: Poland
facility: Local Institution - 0032
city: Lodz
country: Poland
facility: Local Institution - 0033
city: Poznan
country: Poland
facility: Local Institution - 0042
city: Warszawa
country: Poland
facility: Local Institution - 0035
city: Bucharest
country: Romania
facility: Local Institution - 0135
city: Craiova
country: Romania
facility: Local Institution - 0114
city: Romania
country: Romania
facility: Local Institution - 0113
city: Timisoara, Timis
country: Romania
facility: Local Institution - 0149
city: Moscow
country: Russian Federation
facility: Local Institution - 0122
city: Ryazan
country: Russian Federation
facility: Local Institution - 0121
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution - 0126
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 0119
city: Barcelona
country: Spain
facility: Local Institution - 0006
city: Barcelona
country: Spain
facility: Local Institution - 0005
city: Madrid
country: Spain
facility: Local Institution - 0004
city: Madrid
country: Spain
facility: Local Institution - 0003
city: Sevilla
country: Spain
facility: Local Institution - 0008
city: Valencia
country: Spain
facility: Local Institution - 0007
city: Basel
country: Switzerland
facility: Local Institution - 0104
city: Lausanne
country: Switzerland
facility: Local Institution - 0133
city: Winterthur
country: Switzerland
facility: Local Institution - 0109
city: Zurich
country: Switzerland
facility: Local Institution - 0156
city: Taichung
country: Taiwan
facility: Local Institution - 0143
city: London
country: United Kingdom
facility: Local Institution - 0157
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution - 0082
state: Greater Manchester
city: Maidstone
country: United Kingdom
facility: Local Institution - 0083
state: Kent
city: Sutton
country: United Kingdom
facility: Local Institution - 0124
state: Surrey
city: Southampton
country: United Kingdom
facility: Local Institution - 0123
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: