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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
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)
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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)
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Secondary ID [1]
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2014-003630-23
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Secondary ID [2]
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CA209-227
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 227
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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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
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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Timepoint [1]
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approximately 48 months
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Primary outcome [2]
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Progression-free Survival (PFS) as determined by blinded independent central review (BICR)
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Assessment method [2]
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Timepoint [2]
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approximately 40 months
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Secondary outcome [1]
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Objective response rate (ORR)
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Assessment method [1]
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ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer
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Timepoint [1]
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Up to 48 months
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Secondary outcome [2]
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Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects
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Assessment method [2]
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Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment
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Timepoint [2]
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Up to 48 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
2748
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0182 - Garran
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Local Institution - 0301 - Blacktown
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Local Institution - 0300 - Gosford
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Local Institution - 0183 - Tamworth
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Local Institution - 0045 - Brisbane
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Local Institution - 0046 - Elizabeth Vale
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Local Institution - 0043 - Clayton
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Local Institution - 0042 - Fitzroy
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Local Institution - 0180 - Perth
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Local Institution - 0040 - Murdoch
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2605 - Garran
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2148 - Blacktown
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2250 - Gosford
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2340 - Tamworth
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Recruitment postcode(s) [5]
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4102 - Brisbane
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Recruitment postcode(s) [6]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [7]
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3168 - Clayton
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Recruitment postcode(s) [8]
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3065 - Fitzroy
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Recruitment postcode(s) [9]
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6150 - Perth
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Recruitment postcode(s) [10]
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6150 - Murdoch
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Recruitment outside Australia
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Alabama
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Japan
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Gunma
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Japan
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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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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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Shizuoka
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Japan
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Tokyo
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Japan
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Wakayama
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Japan
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Yamaguchi
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Gangnam-gu
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Korea, Republic of
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Seoul
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Lebanon
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Beirut
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Mexico
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Distrito Federal
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Mexico
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Estado DE Mexico
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Mexico
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Jalisco
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Mexico
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Mexico
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Nuevo Leon
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Mexico
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Yucatán
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Mexico
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Chihuahua
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Mexico
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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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Amsterdam
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Breda
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Netherlands
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Rotterdam
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Netherlands
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Veldhoven
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Peru
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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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Poland
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Gliwice
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Poland
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Lodz
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Poland
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Warszawa
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Poland
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Wroclaw
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Romania
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Craiova
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Romania
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Floresti
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Romania
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Romania
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Romania
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Sector 2
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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
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Basel
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Switzerland
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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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Taiwan
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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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United Kingdom
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Cleveland
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United Kingdom
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Greater London
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United Kingdom
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Hampshire
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United Kingdom
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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
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Other collaborator category [1]
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0
Commercial sector/industry
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Name [1]
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Ono Pharmaceutical Co. Ltd
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0
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02477826
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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. Reck M, Schenker M, Lee KH, Provencio M, Nishio M, Lesniewski-Kmak K, Sangha R, Ahmed S, Raimbourg J, Feeney K, Corre R, Franke FA, Richardet E, Penrod JR, Yuan Y, Nathan FE, Bhagavatheeswaran P, DeRosa M, Taylor F, Lawrance R, Brahmer J. Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial. Eur J Cancer. 2019 Jul;116:137-147. doi: 10.1016/j.ejca.2019.05.008. Epub 2019 Jun 11. Hellmann MD, Ciuleanu TE, Pluzanski A, Lee JS, Otterson GA, Audigier-Valette C, Minenza E, Linardou H, Burgers S, Salman P, Borghaei H, Ramalingam SS, Brahmer J, Reck M, O'Byrne KJ, Geese WJ, Green G, Chang H, Szustakowski J, Bhagavatheeswaran P, Healey D, Fu Y, Nathan F, Paz-Ares L. Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden. N Engl J Med. 2018 May 31;378(22):2093-2104. doi: 10.1056/NEJMoa1801946. Epub 2018 Apr 16.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
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Results not provided in
https://clinicaltrials.gov/study/NCT02477826
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