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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02477826




Registration number
NCT02477826
Ethics application status
Date submitted
18/06/2015
Date registered
23/06/2015
Date last updated
8/01/2024

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
Treatment: Drugs - Nivolumab
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Paclitaxel

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


Treatment: Drugs: Nivolumab


Treatment: Drugs: Ipilimumab


Treatment: Drugs: Carboplatin


Treatment: Drugs: Cisplatin


Treatment: Drugs: Gemcitabine


Treatment: Drugs: Pemetrexed


Treatment: Drugs: Paclitaxel
Intervention code [1] 0 0
Treatment: Drugs
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
Active, not recruiting
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
30/08/2024
Actual
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 - 0183 - Tamworth
Recruitment hospital [5] 0 0
Local Institution - 0045 - Brisbane
Recruitment hospital [6] 0 0
Local Institution - 0046 - Elizabeth Vale
Recruitment hospital [7] 0 0
Local Institution - 0043 - Clayton
Recruitment hospital [8] 0 0
Local Institution - 0042 - Fitzroy
Recruitment hospital [9] 0 0
Local Institution - 0180 - Perth
Recruitment hospital [10] 0 0
Local Institution - 0040 - Murdoch
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
2340 - Tamworth
Recruitment postcode(s) [5] 0 0
4102 - Brisbane
Recruitment postcode(s) [6] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
6150 - Perth
Recruitment postcode(s) [10] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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United States of America
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California
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Connecticut
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United States of America
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Georgia
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Kentucky
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United States of America
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Missouri
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New York
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Ohio
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Pennsylvania
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United States of America
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South Carolina
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Tennessee
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Texas
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Utah
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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RIO Negro
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Argentina
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Tucuman
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Argentina
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Cordoba
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Argentina
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Córdoba
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Austria
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Graz
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Austria
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Vienna
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Austria
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Wels
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Belgium
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West-Vlaanderen
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Gilly
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Belgium
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Hasselt
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Belgium
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Sint Niklaas
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Brazil
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Bahia
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Brazil
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RIO Grande DO SUL
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Brazil
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Rio De Janeiro
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Alberta
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Newfoundland and Labrador
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Canada
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Ontario
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Quebec
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Chile
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Chile
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Valparaiso
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China
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Anhui
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China
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China
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China
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China
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China
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Jilin
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Liaoning
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China
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China
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China
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China
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China
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Xinjiang
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China
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China
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Risaralda
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Colombia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Praha 4
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Czechia
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Pribram
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Finland
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Oulu
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Finland
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Turku
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France
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Rhône
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France
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ANGERS Cedex 2
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France
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Besançon Cedex
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France
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Caen
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France
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Creteil
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France
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Limoges
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Marseille Cedex 20
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Paris
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Pessac
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Rennes
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Rouen Cedex
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Saint Priest En Jarez
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Saint-herblain Cedex
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Strasbourg
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Toulon
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Sachsen-Anhalt
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Germany
State/province [89] 0 0
Bad Berka
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Germany
State/province [90] 0 0
Berlin
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Germany
State/province [91] 0 0
Essen
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Germany
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Frankfurt
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Germany
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Gera
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Germany
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Grosshansdorf
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Germany
State/province [95] 0 0
Halle
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Germany
State/province [96] 0 0
Heidelberg
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Germany
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Hemer
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Germany
State/province [98] 0 0
Immenstadt
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Germany
State/province [99] 0 0
Muenchen
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Germany
State/province [100] 0 0
Stuttgart
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Germany
State/province [101] 0 0
Wiesbaden
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Greece
State/province [102] 0 0
Attikí
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Greece
State/province [103] 0 0
Heraklion
Country [104] 0 0
Greece
State/province [104] 0 0
Neo Faliro
Country [105] 0 0
Greece
State/province [105] 0 0
Thessaloniki
Country [106] 0 0
Hungary
State/province [106] 0 0
Budapest
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Hungary
State/province [107] 0 0
Matrahaza
Country [108] 0 0
Ireland
State/province [108] 0 0
Dublin
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Ireland
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Galway
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Ireland
State/province [110] 0 0
Limerick
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Israel
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Jerusalem
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Israel
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Kfar-saba
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Israel
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Petach Tikva
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Israel
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Tel-hashomer
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Israel
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Zerifin
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Italy
State/province [116] 0 0
Lombardia
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Italy
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Avellino
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State/province [118] 0 0
Bergamo
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Italy
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Bologna
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Messina
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Milan
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State/province [123] 0 0
Napoli
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Perugia
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Italy
State/province [125] 0 0
Ravenna
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Italy
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Roma
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Italy
State/province [127] 0 0
Terni
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Gunma
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Niigata
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Okayama
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Japan
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Osaka
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Japan
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Japan
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Japan
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Tokyo
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Cheongju-si
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Korea, Republic of
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Korea, Republic of
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Jalisco
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Chihuahua
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San Luis Potosi
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Mexico
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Toluca
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Netherlands
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Breda
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Netherlands
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Lima
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Gdynia
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Gliwice
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Lodz
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Warszawa
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Craiova
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Romania
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Floresti
Country [175] 0 0
Romania
State/province [175] 0 0
Romania
Country [176] 0 0
Romania
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Sector 2
Country [177] 0 0
Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Ufa
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South Africa
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Gauteng
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South Africa
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Vereeniging
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Spain
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Madrid
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Spain
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Barcelona
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Spain
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Sevilla
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Spain
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Valencia
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Switzerland
State/province [189] 0 0
Basel
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Switzerland
State/province [190] 0 0
Chur
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Switzerland
State/province [191] 0 0
Lausanne
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Switzerland
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Winterthur
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Taiwan
State/province [193] 0 0
Taichung
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Taiwan
State/province [194] 0 0
Taipei
Country [195] 0 0
Taiwan
State/province [195] 0 0
Taoyuan city
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Cleveland
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Greater London
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Hampshire
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Leicestershire
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Birmingham
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Cambridgeshire
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United Kingdom
State/province [202] 0 0
Edinburgh
Country [203] 0 0
United Kingdom
State/province [203] 0 0
London
Country [204] 0 0
United Kingdom
State/province [204] 0 0
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/ct2/show/NCT02477826
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02477826