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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
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United States of America
State/province [2] 0 0
Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Kansas
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United States of America
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Kentucky
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Michigan
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New York
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Ohio
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Pennsylvania
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South Carolina
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Utah
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Rio Negro
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Argentina
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Santa Fe
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Belgium
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Gilly
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Leuven
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Roeselare
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RIO Grande DO Norte
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Sao Paulo
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São Paulo
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Metropolitana
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Chile
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Región Metropolitana De Santiago
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Chile
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Valparaiso
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China
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BEI
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Hainan
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China
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Henan
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Hunan
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China
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Jilin
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Shan3xi
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Zhejiang
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Beijing
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China
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Shanghai
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France
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Rhone Alpes
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Caen
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Lille Cedex
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Nantes
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Paris Cedex 20
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Germany
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Berlin
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Germany
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Gauting
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Germany
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Grosshansdorf
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Germany
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Hemer
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Germany
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Immenhausen
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Germany
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Magdeburg
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Germany
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Muenchen
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Germany
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Yes
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Ireland
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Dublin
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Ireland
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Limerick
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Lucca
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Milano
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Napoli
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Fukushima
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Gunma
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Hiroshima
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Hokkaido
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Hyogo
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Japan
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Ishikawa
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Iwate
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Japan
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Kanagawa
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Japan
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Niigata
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Yamaguchi
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Mexico
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BAJA Californa SUR
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Mexico
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Jalisco
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Mexico
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Veracruz, Veracruz
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Poland
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Bydgoszcz
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Bytom
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Poland
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Gdansk
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Romania
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Bucharest
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Romania
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Cluj Napoca
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Romania
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Craiova
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Russian Federation
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Moscow
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Russian Federation
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St.petersburg
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Spain
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A Coruña
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
State/province [89] 0 0
Valencia
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United Kingdom
State/province [90] 0 0
Guildford
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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
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
Trial website
https://clinicaltrials.gov/study/NCT03215706
Trial related presentations / publications
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. Erratum In: Lancet Oncol. 2021 Mar;22(3):e92. doi: 10.1016/S1470-2045(21)00082-6.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03215706