Clinical trial NCT03215706: A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC
Official title: A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-07-12
Enrollment: 719
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 determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease


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

Inclusion Criteria:

* Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
* Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
* Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period

Exclusion Criteria:

* Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 \[L858R\] substitution mutations) are excluded
* Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
* Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment

Other protocol inclusion/exclusion criteria may apply

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
Secondary outcomes:
measure: Progression Free Survival (PFS) by BICR
timeFrame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2019, approximately 23 months)
measure: Objective Response Rate (ORR) by BICR
timeFrame: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to October 2019, approximately 23 months)
measure: Duration of Response (DoR)
timeFrame: From date of first confirmed response to date of tumor progression (assessed up to October 2019, approximately 23 months)
measure: Time to Response (TTR)
timeFrame: From date of randomization to date of first confirmed documented response (assessed up to October 2019, approximately 23 months)
measure: Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
timeFrame: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to October 2019, approximately 23 months)
measure: PFS by BICR by PD-L1 Tumor Cell Expression
timeFrame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2019, approximately 23 months)
measure: OS by PD-L1 Tumor Cell Expression
timeFrame: From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Memorial Health Systems
state: Colorado
city: Plainville
country: United States
facility: Local Institution - 0044
state: Connecticut
city: Jacksonville
country: United States
facility: Local Institution - 0045
state: Florida
city: Marietta
country: United States
facility: Local Institution - 0029
state: Georgia
city: Wichita
country: United States
facility: Local Institution - 0091
state: Kansas
city: Lexington
country: United States
facility: Local Institution - 0004
state: Kentucky
city: Detroit
country: United States
facility: Local Institution - 0105
state: Michigan
city: Johnson City
country: United States
facility: Local Institution - 0058
state: New York
city: Mineola
country: United States
facility: Local Institution - 0098
state: New York
city: Columbus
country: United States
facility: Local Institution - 0095
state: Ohio
city: Lancaster
country: United States
facility: Local Institution - 0006
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0047
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0093
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0094
state: South Carolina
city: Saint George
country: United States
facility: Southwest Regional Cancer Clinic
state: Utah
city: Madison
country: United States
facility: Local Institution - 0099
state: Wisconsin
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0014
state: Buenos Aires
city: Rio Cuarto
country: Argentina
facility: Local Institution - 0028
state: Cordoba
city: Viedma
country: Argentina
facility: Local Institution - 0026
state: Rio Negro
city: Rosario
country: Argentina
facility: Local Institution - 0027
state: Santa Fe
city: Cordoba
country: Argentina
facility: Local Institution - 0030
city: Gosford
country: Australia
facility: Local Institution - 0086
state: New South Wales
city: Bedford Park
country: Australia
facility: Local Institution - 0040
state: South Australia
city: Box Hill
country: Australia
facility: Local Institution - 0089
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution - 0036
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 0078
state: Western Australia
city: Gilly
country: Belgium
facility: Local Institution - 0002
city: Leuven
country: Belgium
facility: Local Institution - 0033
city: Roeselare
country: Belgium
facility: Local Institution - 0001
city: Natal
country: Brazil
facility: Local Institution - 0068
state: RIO Grande DO Norte
city: Ijui
country: Brazil
facility: Local Institution - 0063
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution - 0067
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Local Institution - 0069
state: Santa Catarina
city: Barretos
country: Brazil
facility: Local Institution - 0064
state: Sao Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Local Institution - 0065
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution - 0066
city: São Paulo
country: Brazil
facility: Local Institution - 0070
city: Montreal
country: Canada
facility: Local Institution - 0090
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0083
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0082
state: Quebec
city: Rimouski
country: Canada
facility: Local Institution - 0080
state: Quebec
city: Santiago
country: Chile
facility: Local Institution - 0084
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0059
state: Región Metropolitana De Santiago
city: Vina Del Mar
country: Chile
facility: Local Institution - 0079
state: Valparaiso
city: Beijing
country: China
facility: Local Institution - 0139
state: BEI
city: Haikou
country: China
facility: Local Institution - 0146
state: Hainan
city: Zhengzhou
country: China
facility: Local Institution - 0148
state: Henan
city: Zhengzhou
country: China
facility: Local Institution - 0120
state: Henan
city: Changsha
country: China
facility: Local Institution - 0144
state: Hunan
city: Changchun
country: China
facility: Local Institution - 0106
state: Jilin
city: Xi'an City
country: China
facility: Local Institution - 0108
state: Shan3xi
city: Hangzhou
country: China
facility: Local Institution - 0110
state: Zhejiang
city: Zhejiang
country: China
facility: Local Institution - 0111
state: Zhejiang
city: Beijing
country: China
facility: Local Institution - 0113
city: Shanghai
country: China
facility: Local Institution - 0112
city: Bron
country: France
facility: Local Institution - 0010
state: Rhone Alpes
city: Lyon Cedex08
country: France
facility: Local Institution - 0009
state: Rhône-Alpes
city: Caen
country: France
facility: Local Institution - 0013
city: Lille Cedex
country: France
facility: Local Institution - 0071
city: Montpellier
country: France
facility: Local Institution - 0012
city: Nantes
country: France
facility: Local Institution - 0035
city: Paris Cedex 20
country: France
facility: Local Institution - 0011
city: Saint-Brieuc
country: France
facility: Local Institution - 0097
city: Berlin
country: Germany
facility: Local Institution - 0073
city: Gauting
country: Germany
facility: Local Institution - 0016
city: Grosshansdorf
country: Germany
facility: Local Institution - 0072
city: Hemer
country: Germany
facility: Local Institution - 0019
city: Immenhausen
country: Germany
facility: Local Institution - 0017
city: Magdeburg
country: Germany
facility: Local Institution - 0074
city: Muenchen
country: Germany
facility: Local Institution - 0015
city: Stuttgart
country: Germany
facility: Local Institution - 0018
city: Dublin
country: Ireland
facility: Local Institution - 0021
city: Limerick
country: Ireland
facility: Local Institution - 0020
city: Lucca
country: Italy
facility: Local Institution - 0042
city: Milano
country: Italy
facility: Local Institution - 0041
city: Napoli
country: Italy
facility: Local Institution - 0043
city: Fukushima-shi
country: Japan
facility: Local Institution - 0101
state: Fukushima
city: Maebashi-shi
country: Japan
facility: Local Institution - 0118
state: Gunma
city: Ota-shi
country: Japan
facility: Local Institution - 0128
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Local Institution - 0138
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Local Institution - 0137
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Local Institution - 0127
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Local Institution - 0131
state: Hyogo
city: Himeji-shi
country: Japan
facility: Local Institution - 0119
state: Hyogo
city: Kobe-shi
country: Japan
facility: Local Institution - 0104
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Local Institution - 0115
state: Ishikawa
city: Shiwa-gun
country: Japan
facility: Local Institution - 0100
state: Iwate
city: Yokohama-shi
country: Japan
facility: Local Institution - 0129
state: Kanagawa
city: Yokohama-Shi
country: Japan
facility: Local Institution - 0114
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Local Institution - 0134
state: Kanagawa
city: Niigata-shi
country: Japan
facility: Local Institution - 0116
state: Niigata
city: Okayama-shi
country: Japan
facility: Local Institution - 0136
state: Okayama
city: Habikino-shi
country: Japan
facility: Local Institution - 0135
state: Osaka
city: Osaka-Sayama
country: Japan
facility: Local Institution - 0103
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Local Institution - 0102
state: Saitama
city: Ube-shi
country: Japan
facility: Local Institution - 0132
state: Yamaguchi
city: Osaka
country: Japan
facility: Local Institution - 0130
city: La Paz
country: Mexico
facility: Local Institution - 0077
state: BAJA Californa SUR
city: Guadalajara
country: Mexico
facility: Local Institution - 0061
state: Jalisco
city: Veracruz, Veracruz
country: Mexico
facility: Local Institution - 0075
city: Bydgoszcz
country: Poland
facility: Local Institution - 0087
city: Bytom
country: Poland
facility: Local Institution - 0022
city: Gdańsk
country: Poland
facility: Local Institution - 0085
city: Bucharest
country: Romania
facility: Local Institution - 0034
city: Cluj Napoca
country: Romania
facility: Local Institution - 0031
city: Craiova
country: Romania
facility: Local Institution - 0032
city: Moscow
country: Russian Federation
facility: Local Institution - 0024
city: St.petersburg
country: Russian Federation
facility: Local Institution - 0025
city: A Coruña
country: Spain
facility: Local Institution - 0054
city: Barcelona
country: Spain
facility: Local Institution - 0053
city: Madrid
country: Spain
facility: Local Institution - 0052
city: Malaga
country: Spain
facility: Local Institution - 0055
city: Valencia
country: Spain
facility: Local Institution - 0056
city: Guildford
country: United Kingdom
facility: Local Institution - 0050
city: London
country: United Kingdom
facility: Local Institution - 0049
city: Tauton
country: United Kingdom
facility: Local Institution - 0048
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Paz-Ares L, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Salman P, Souquet PJ, De Marchi P, Martin C, Perol M, Scherpereel A, Lu S, John T, Carbone DP, Meadows-Shropshire S, Agrawal S, Oukessou A, Yan J, Reck M. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):198-211. doi: 10.1016/S1470-2045(20)30641-0. Epub 2021 Jan 18.