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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03215706




Registration number
NCT03215706
Ethics application status
Date submitted
11/07/2017
Date registered
12/07/2017
Date last updated
10/01/2024

Titles & IDs
Public title
A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC
Scientific 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
Secondary ID [1] 0 0
2017-001195-35
Secondary ID [2] 0 0
CA209-9LA
Universal Trial Number (UTN)
Trial acronym
CheckMate 9LA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Ipilimumab
Treatment: Other - Nivolumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin

Experimental: Module A - Chemotherapy/Biologics combined

Active comparator: Module B - Chemotherapy Combination


Treatment: Other: Ipilimumab
Specified dose on specified day

Treatment: Other: Nivolumab
Specified dose on specified day

Treatment: Drugs: Carboplatin
Specified dose on specified day

Treatment: Drugs: Paclitaxel
Specified dose on specified day

Treatment: Drugs: Pemetrexed
Specified dose on specified day

Treatment: Drugs: Cisplatin
Specified dose on specified day
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
Secondary outcome [1] 0 0
Progression Free Survival (PFS) by BICR
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Objective Response Rate (ORR) by BICR
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
From date of first confirmed response to date of tumor progression (assessed up to October 2019, approximately 23 months)
Secondary outcome [4] 0 0
Time to Response (TTR)
Timepoint [4] 0 0
From date of randomization to date of first confirmed documented response (assessed up to October 2019, approximately 23 months)
Secondary outcome [5] 0 0
Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
PFS by BICR by PD-L1 Tumor Cell Expression
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
OS by PD-L1 Tumor Cell Expression
Timepoint [7] 0 0
From date of randomization to date of death (assessed up to October 2019, approximately 23 months)

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



* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/01/2026
Actual
Sample size
Target
Accrual to date
Final
719
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0086 - Gosford
Recruitment hospital [2] 0 0
Local Institution - 0040 - Bedford Park
Recruitment hospital [3] 0 0
Local Institution - 0089 - Box Hill
Recruitment hospital [4] 0 0
Local Institution - 0036 - Heidelberg
Recruitment hospital [5] 0 0
Local Institution - 0078 - Murdoch
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Argentina
State/province [16] 0 0
Rio Negro
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa Fe
Country [18] 0 0
Belgium
State/province [18] 0 0
Gilly
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Belgium
State/province [20] 0 0
Roeselare
Country [21] 0 0
Brazil
State/province [21] 0 0
RIO Grande DO Norte
Country [22] 0 0
Brazil
State/province [22] 0 0
Rio Grande Do Sul
Country [23] 0 0
Brazil
State/province [23] 0 0
Santa Catarina
Country [24] 0 0
Brazil
State/province [24] 0 0
Sao Paulo
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio De Janeiro
Country [26] 0 0
Brazil
State/province [26] 0 0
São Paulo
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Chile
State/province [28] 0 0
Metropolitana
Country [29] 0 0
Chile
State/province [29] 0 0
Región Metropolitana De Santiago
Country [30] 0 0
Chile
State/province [30] 0 0
Valparaiso
Country [31] 0 0
China
State/province [31] 0 0
BEI
Country [32] 0 0
China
State/province [32] 0 0
Hainan
Country [33] 0 0
China
State/province [33] 0 0
Henan
Country [34] 0 0
China
State/province [34] 0 0
Hunan
Country [35] 0 0
China
State/province [35] 0 0
Jilin
Country [36] 0 0
China
State/province [36] 0 0
Shan3xi
Country [37] 0 0
China
State/province [37] 0 0
Zhejiang
Country [38] 0 0
China
State/province [38] 0 0
Beijing
Country [39] 0 0
China
State/province [39] 0 0
Shanghai
Country [40] 0 0
France
State/province [40] 0 0
Rhone Alpes
Country [41] 0 0
France
State/province [41] 0 0
Rhône-Alpes
Country [42] 0 0
France
State/province [42] 0 0
Caen
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France
State/province [43] 0 0
Lille Cedex
Country [44] 0 0
France
State/province [44] 0 0
Montpellier
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France
State/province [45] 0 0
Nantes
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France
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Paris Cedex 20
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France
State/province [47] 0 0
Saint-Brieuc
Country [48] 0 0
Germany
State/province [48] 0 0
Berlin
Country [49] 0 0
Germany
State/province [49] 0 0
Gauting
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Germany
State/province [50] 0 0
Grosshansdorf
Country [51] 0 0
Germany
State/province [51] 0 0
Hemer
Country [52] 0 0
Germany
State/province [52] 0 0
Immenhausen
Country [53] 0 0
Germany
State/province [53] 0 0
Magdeburg
Country [54] 0 0
Germany
State/province [54] 0 0
Muenchen
Country [55] 0 0
Germany
State/province [55] 0 0
Yes
Country [56] 0 0
Ireland
State/province [56] 0 0
Dublin
Country [57] 0 0
Ireland
State/province [57] 0 0
Limerick
Country [58] 0 0
Italy
State/province [58] 0 0
Lucca
Country [59] 0 0
Italy
State/province [59] 0 0
Milano
Country [60] 0 0
Italy
State/province [60] 0 0
Napoli
Country [61] 0 0
Japan
State/province [61] 0 0
Fukushima
Country [62] 0 0
Japan
State/province [62] 0 0
Gunma
Country [63] 0 0
Japan
State/province [63] 0 0
Hiroshima
Country [64] 0 0
Japan
State/province [64] 0 0
Hokkaido
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Japan
State/province [65] 0 0
Hyogo
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Japan
State/province [66] 0 0
Ishikawa
Country [67] 0 0
Japan
State/province [67] 0 0
Iwate
Country [68] 0 0
Japan
State/province [68] 0 0
Kanagawa
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Japan
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Niigata
Country [70] 0 0
Japan
State/province [70] 0 0
Okayama
Country [71] 0 0
Japan
State/province [71] 0 0
Osaka
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Japan
State/province [72] 0 0
Saitama
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Japan
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Yamaguchi
Country [74] 0 0
Mexico
State/province [74] 0 0
BAJA Californa SUR
Country [75] 0 0
Mexico
State/province [75] 0 0
Jalisco
Country [76] 0 0
Mexico
State/province [76] 0 0
Veracruz, Veracruz
Country [77] 0 0
Poland
State/province [77] 0 0
Bydgoszcz
Country [78] 0 0
Poland
State/province [78] 0 0
Bytom
Country [79] 0 0
Poland
State/province [79] 0 0
Gdansk
Country [80] 0 0
Romania
State/province [80] 0 0
Bucharest
Country [81] 0 0
Romania
State/province [81] 0 0
Cluj Napoca
Country [82] 0 0
Romania
State/province [82] 0 0
Craiova
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Moscow
Country [84] 0 0
Russian Federation
State/province [84] 0 0
St.petersburg
Country [85] 0 0
Spain
State/province [85] 0 0
A Coruña
Country [86] 0 0
Spain
State/province [86] 0 0
Barcelona
Country [87] 0 0
Spain
State/province [87] 0 0
Madrid
Country [88] 0 0
Spain
State/province [88] 0 0
Malaga
Country [89] 0 0
Spain
State/province [89] 0 0
Valencia
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Guildford
Country [91] 0 0
United Kingdom
State/province [91] 0 0
London
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Tauton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03215706