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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02477826




Registration number
NCT02477826
Ethics application status
Date submitted
18/06/2015
Date registered
23/06/2015
Date last updated
19/11/2024

Titles & IDs
Public title
An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Scientific title
An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
2014-003630-23
Secondary ID [2] 0 0
CA209-227
Universal Trial Number (UTN)
Trial acronym
CheckMate 227
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
Experimental: Arm A: Nivolumab - Nivolumab intravenously (IV) as specified

Experimental: Arm B: Nivolumab + Ipilimumab - Nivolumab + Ipilimumab IV as specified

Experimental: Arm C: Nivolumab + Platinum doublet chemotherapy - Nivolumab + Platinum doublet chemotherapy (IV) dose as specified

Experimental: Arm D: Platinum doublet chemotherapy - Chemotherapy administered on specified days of IV chemotherapy
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
approximately 48 months
Primary outcome [2] 0 0
Progression-free Survival (PFS) as determined by blinded independent central review (BICR)
Timepoint [2] 0 0
approximately 40 months
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Up to 48 months
Secondary outcome [2] 0 0
Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects
Timepoint [2] 0 0
Up to 48 months

Eligibility
Key inclusion criteria
* Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
* Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with untreated Central nervous system (CNS) metastases are excluded
* Subjects with an active, known or suspected autoimmune disease are excluded
* Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection

Other protocol defined inclusion/exclusion criteria 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2024
Sample size
Target
Accrual to date
Final
2748
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0182 - Garran
Recruitment hospital [2] 0 0
Local Institution - 0301 - Blacktown
Recruitment hospital [3] 0 0
Local Institution - 0300 - Gosford
Recruitment hospital [4] 0 0
Local Institution - 0045 - Brisbane
Recruitment hospital [5] 0 0
Local Institution - 0046 - Elizabeth Vale
Recruitment hospital [6] 0 0
Local Institution - 0043 - Clayton
Recruitment hospital [7] 0 0
Local Institution - 0042 - Fitzroy
Recruitment hospital [8] 0 0
Local Institution - 0180 - Perth
Recruitment hospital [9] 0 0
Local Institution - 0040 - Murdoch
Recruitment hospital [10] 0 0
Local Institution - 0183 - North Tamworth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
6150 - Perth
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment postcode(s) [10] 0 0
2340 - North Tamworth
Recruitment outside Australia
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Alabama
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Washington
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Argentina
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Buenos Aires
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Romania
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Sevilla
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Valencia
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Basel
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Chur
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Switzerland
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Lausanne
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Switzerland
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Winterthur
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan city
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Cleveland
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Greater London
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Hampshire
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Leicestershire
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United Kingdom
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Birmingham
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United Kingdom
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Cambridgeshire
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United Kingdom
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Edinburgh
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United Kingdom
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London
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United Kingdom
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Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.
Trial website
https://clinicaltrials.gov/study/NCT02477826
Trial related presentations / publications
Reck M, Ciuleanu TE, Lee JS, Schenker M, Audigier-Valette C, Zurawski B, Linardou H, Otterson GA, Salman P, Nishio M, de la Mora Jimenez E, Lesniewski-Kmak K, Albert I, Ahmed S, Syrigos K, Penrod JR, Yuan Y, Blum SI, Nathan FE, Sun X, Moreno-Koehler A, Taylor F, O'Byrne KJ. First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in Advanced NSCLC With 1% or Greater Tumor PD-L1 Expression: Patient-Reported Outcomes From CheckMate 227 Part 1. J Thorac Oncol. 2021 Apr;16(4):665-676. doi: 10.1016/j.jtho.2020.12.019. Epub 2021 Jan 21.
Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim SW, Carcereny Costa E, Park K, Alexandru A, Lupinacci L, de la Mora Jimenez E, Sakai H, Albert I, Vergnenegre A, Peters S, Syrigos K, Barlesi F, Reck M, Borghaei H, Brahmer JR, O'Byrne KJ, Geese WJ, Bhagavatheeswaran P, Rabindran SK, Kasinathan RS, Nathan FE, Ramalingam SS. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019 Nov 21;381(21):2020-2031. doi: 10.1056/NEJMoa1910231. Epub 2019 Sep 28.
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02477826