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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 : November 29, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Nivolumab Drug: Ipilimumab Drug: Carboplatin Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed Drug: Paclitaxel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : August 5, 2015
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Nivolumab
Nivolumab intravenously (IV) as specified
 Drug: Nivolumab
Other Name: Opdivo
Experimental: Arm B: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab IV as specified
 Drug: Nivolumab
Other Name: Opdivo

Drug: Ipilimumab
Other Name: Yervoy
Experimental: Arm C: Nivolumab + Platinum doublet chemotherapy
Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
 Drug: Nivolumab
Other Name: Opdivo

Drug: Carboplatin
Drug: Cisplatin
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Paclitaxel
Experimental: Arm D: Platinum doublet chemotherapy
Chemotherapy administered on specified days of IV chemotherapy
 Drug: Carboplatin
Drug: Cisplatin
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Paclitaxel


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: approximately 48 months ]
  2. Progression-free Survival (PFS) as determined by blinded independent central review (BICR) [ Time Frame: approximately 40 months ]

Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477826


Contacts
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 #.

  Show 301 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site
BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site
Investigator Inquiry Form  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02477826     History of Changes
Other Study ID Numbers: CA209-227
2014-003630-23 ( EudraCT Number )
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Pemetrexed
Nivolumab
Carboplatin
 Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors