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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) (CheckMate 227)

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ClinicalTrials.gov Identifier: NCT02477826
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : September 11, 2020
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE June 18, 2015
First Posted Date  ICMJE June 23, 2015
Last Update Posted Date September 11, 2020
Actual Study Start Date  ICMJE August 5, 2015
Estimated Primary Completion Date November 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Overall survival (OS) [ Time Frame: approximately 48 months ]
  • Progression-free Survival (PFS) as determined by blinded independent central review (BICR) [ Time Frame: approximately 40 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
  • Overall survival (OS) [ Time Frame: approximately 48 months ]
    OS of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer
  • Progression-free survival (PFS) [ Time Frame: approximately 40 months ]
    PFS of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Objective response rate (ORR) [ Time Frame: Up to 48 months ]
    ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer
  • Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects [ Time Frame: Up to 48 months ]
    Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
  • Objective response rate (ORR) [ Time Frame: upto 48 months ]
    ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer
  • Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects [ Time Frame: upto 48 months ]
    Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Nivolumab
    Other Name: Opdivo
  • Drug: Ipilimumab
    Other Name: Yervoy
  • Drug: Carboplatin
  • Drug: Cisplatin
  • Drug: Gemcitabine
  • Drug: Pemetrexed
  • Drug: Paclitaxel
Study Arms  ICMJE
  • Experimental: Arm A: Nivolumab
    Nivolumab intravenously (IV) as specified
    Intervention: Drug: Nivolumab
  • Experimental: Arm B: Nivolumab + Ipilimumab
    Nivolumab + Ipilimumab IV as specified
    Interventions:
    • Drug: Nivolumab
    • Drug: Ipilimumab
  • Experimental: Arm C: Nivolumab + Platinum doublet chemotherapy
    Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
    Interventions:
    • Drug: Nivolumab
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Gemcitabine
    • Drug: Pemetrexed
    • Drug: Paclitaxel
  • Experimental: Arm D: Platinum doublet chemotherapy
    Chemotherapy administered on specified days of IV chemotherapy
    Interventions:
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Gemcitabine
    • Drug: Pemetrexed
    • Drug: Paclitaxel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2016)
2220
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2015)
1980
Estimated Study Completion Date  ICMJE August 23, 2022
Estimated Primary Completion Date November 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

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 could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Czechia,   Finland,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Lebanon,   Mexico,   Netherlands,   Peru,   Poland,   Romania,   Russian Federation,   Saudi Arabia,   South Africa,   Spain,   Switzerland,   Taiwan,   Turkey,   United Arab Emirates,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02477826
Other Study ID Numbers  ICMJE CA209-227
2014-003630-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP