A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC
NCT ID: NCT03215706
Last Updated: 2024-12-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
719 participants
INTERVENTIONAL
2017-08-24
2024-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Module A
Chemotherapy/Biologics combined
Ipilimumab
Specified dose on specified day
Nivolumab
Specified dose on specified day
Carboplatin
Specified dose on specified day
Paclitaxel
Specified dose on specified day
Pemetrexed
Specified dose on specified day
Cisplatin
Specified dose on specified day
Module B
Chemotherapy Combination
Carboplatin
Specified dose on specified day
Paclitaxel
Specified dose on specified day
Pemetrexed
Specified dose on specified day
Cisplatin
Specified dose on specified day
Interventions
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Ipilimumab
Specified dose on specified day
Nivolumab
Specified dose on specified day
Carboplatin
Specified dose on specified day
Paclitaxel
Specified dose on specified day
Pemetrexed
Specified dose on specified day
Cisplatin
Specified dose on specified day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Memorial Health Systems
Colorado Springs, Colorado, United States
Local Institution - 0044
Plainville, Connecticut, United States
Local Institution - 0045
Jacksonville, Florida, United States
Local Institution - 0029
Marietta, Georgia, United States
Local Institution - 0091
Wichita, Kansas, United States
Local Institution - 0004
Lexington, Kentucky, United States
Local Institution - 0105
Detroit, Michigan, United States
Local Institution - 0058
Johnson City, New York, United States
Local Institution - 0098
Mineola, New York, United States
Local Institution - 0095
Columbus, Ohio, United States
Local Institution - 0006
Lancaster, Pennsylvania, United States
Local Institution - 0047
Pittsburgh, Pennsylvania, United States
Local Institution - 0093
Pittsburgh, Pennsylvania, United States
Local Institution - 0094
Charleston, South Carolina, United States
Southwest Regional Cancer Clinic
St. George, Utah, United States
Local Institution - 0099
Madison, Wisconsin, United States
Local Institution - 0014
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0028
Río Cuarto, Córdoba Province, Argentina
Local Institution - 0026
Viedma, Río Negro Province, Argentina
Local Institution - 0027
Rosario, Santa Fe Province, Argentina
Local Institution - 0030
Córdoba, , Argentina
Local Institution - 0086
Gosford, New South Wales, Australia
Local Institution - 0040
Bedford Park, South Australia, Australia
Local Institution - 0089
Box Hill, Victoria, Australia
Local Institution - 0036
Heidelberg, Victoria, Australia
Local Institution - 0078
Murdoch, Western Australia, Australia
Local Institution - 0002
Gilly, , Belgium
Local Institution - 0033
Leuven, , Belgium
Local Institution - 0001
Roeselare, , Belgium
Local Institution - 0068
Natal, Rio Grande do Norte, Brazil
Local Institution - 0063
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0067
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0069
Blumenau, Santa Catarina, Brazil
Local Institution - 0064
Barretos, São Paulo, Brazil
Local Institution - 0065
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0066
Rio de Janeiro, , Brazil
Local Institution - 0070
São Paulo, , Brazil
Local Institution - 0090
Montreal, Quebec, Canada
Local Institution - 0083
Montreal, Quebec, Canada
Local Institution - 0082
Montreal, Quebec, Canada
Local Institution - 0080
Rimouski, Quebec, Canada
Local Institution - 0079
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0059
Santiago, Santiago Metropolitan, Chile
Local Institution - 0084
Santiago, Santiago Metropolitan, Chile
Local Institution - 0139
Beijing, BEI, China
Local Institution - 0146
Haikou, Hainan, China
Local Institution - 0148
Zhengzhou, Henan, China
Local Institution - 0120
Zhengzhou, Henan, China
Local Institution - 0144
Changsha, Hunan, China
Local Institution - 0106
Changchun, Jilin, China
Local Institution - 0108
Xi'an, Shan3xi, China
Local Institution - 0110
Hangzhou, Zhejiang, China
Local Institution - 0111
Zhejiang, Zhejiang, China
Local Institution - 0113
Beijing, , China
Local Institution - 0112
Shanghai, , China
Local Institution - 0010
Bron, Auvergne-Rhône-Alpes, France
Local Institution - 0009
Lyon Cedex08, Auvergne-Rhône-Alpes, France
Local Institution - 0013
Caen, , France
Local Institution - 0071
Lille, , France
Local Institution - 0012
Montpellier, , France
Local Institution - 0035
Nantes, , France
Local Institution - 0011
Paris, , France
Local Institution - 0097
Saint-Brieuc, , France
Local Institution - 0073
Berlin, , Germany
Local Institution - 0016
Gauting, , Germany
Local Institution - 0072
Großhansdorf, , Germany
Local Institution - 0019
Hemer, , Germany
Local Institution - 0017
Immenhausen, , Germany
Local Institution - 0074
Magdeburg, , Germany
Local Institution - 0015
München, , Germany
Local Institution - 0018
Stuttgart, , Germany
Local Institution - 0021
Dublin, , Ireland
Local Institution - 0020
Limerick, , Ireland
Local Institution - 0042
Lucca, , Italy
Local Institution - 0041
Milan, , Italy
Local Institution - 0043
Napoli, , Italy
Local Institution - 0101
Fukushima, Fukushima, Japan
Local Institution - 0118
Maebashi, Gunma, Japan
Local Institution - 0128
Ota-shi, Gunma, Japan
Local Institution - 0138
Hiroshima, Hiroshima, Japan
Local Institution - 0137
Hiroshima, Hiroshima, Japan
Local Institution - 0127
Sapporo, Hokkaido, Japan
Local Institution - 0131
Akashi-shi, Hyōgo, Japan
Local Institution - 0119
Himeji-shi, Hyōgo, Japan
Local Institution - 0104
Kobe, Hyōgo, Japan
Local Institution - 0115
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0100
Shiwa-gun, Iwate, Japan
Local Institution - 0129
Yokohama, Kanagawa, Japan
Local Institution - 0114
Yokohama, Kanagawa, Japan
Local Institution - 0134
Yokohama, Kanagawa, Japan
Local Institution - 0116
Niigata, Niigata, Japan
Local Institution - 0136
Okayama, Okayama-ken, Japan
Local Institution - 0135
Habikino-shi, Osaka, Japan
Local Institution - 0103
Ōsaka-sayama, Osaka, Japan
Local Institution - 0102
Kitaadachi-gun, Saitama, Japan
Local Institution - 0132
Ube-shi, Yamaguchi, Japan
Local Institution - 0130
Osaka, , Japan
Local Institution - 0077
La Paz, BAJA Californa SUR, Mexico
Local Institution - 0061
Guadalajara, Jalisco, Mexico
Local Institution - 0075
Veracruz, Veracruz, , Mexico
Local Institution - 0087
Bydgoszcz, , Poland
Local Institution - 0022
Bytom, , Poland
Local Institution - 0085
Gdansk, , Poland
Local Institution - 0034
Bucharest, , Romania
Local Institution - 0031
Cluj-Napoca, , Romania
Local Institution - 0032
Craiova, , Romania
Local Institution - 0024
Moscow, , Russia
Local Institution - 0025
Saint Petersburg, , Russia
Local Institution - 0054
A Coruña, , Spain
Local Institution - 0053
Barcelona, , Spain
Local Institution - 0052
Madrid, , Spain
Local Institution - 0055
Málaga, , Spain
Local Institution - 0056
Valencia, , Spain
Local Institution - 0050
Guildford, , United Kingdom
Local Institution - 0049
London, , United Kingdom
Local Institution - 0048
Tauton, , United Kingdom
Countries
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References
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Peters S, Paz-Ares LG, Reck M, Carbone DP, Brahmer JR, Borghaei H, Lu S, O'Byrne KJ, John T, Ciuleanu TE, Schenker M, Bernabe Caro R, Nishio M, Cobo M, Lee JS, Zurawski B, Pluzanski A, Aoyama T, Tschaika M, Devas V, Grootendorst DJ, Ramalingam SS. Long-Term Survival Outcomes With First-Line Nivolumab Plus Ipilimumab-Based Treatment in Patients With Metastatic NSCLC and Tumor Programmed Death-Ligand 1 Lower Than 1%: A Pooled Analysis. J Thorac Oncol. 2025 Jan;20(1):94-108. doi: 10.1016/j.jtho.2024.09.1439. Epub 2024 Oct 4.
Reck M, Ciuleanu TE, Schenker M, Bordenave S, Cobo M, Juan-Vidal O, Reinmuth N, Richardet E, Felip E, Menezes J, Cheng Y, Mizutani H, Zurawski B, Alexandru A, Carbone DP, Lu S, John T, Aoyama T, Grootendorst DJ, Hu N, Eccles LJ, Paz-Ares LG. Five-year outcomes with first-line nivolumab plus ipilimumab with 2 cycles of chemotherapy versus 4 cycles of chemotherapy alone in patients with metastatic non-small cell lung cancer in the randomized CheckMate 9LA trial. Eur J Cancer. 2024 Nov;211:114296. doi: 10.1016/j.ejca.2024.114296. Epub 2024 Aug 25.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2017-001195-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-9LA
Identifier Type: -
Identifier Source: org_study_id