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Trial record 1 of 1 for:
CheckMate-227
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)
This study is currently recruiting participants.
Verified March 2017 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02477826
First received: June 18, 2015
Last updated: April 18, 2017
Last verified: March 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Non-Small Cell Lung Cancer | Drug: Nivolumab Drug: Ipilimumab Drug: Carboplatin Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed Drug: Paclitaxel | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 2220 |
| Study Start Date: | August 2015 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
Active Comparator: Arm D: Platinum doublet chemotherapy
Chemotherapy administered on specified days of IV chemotherapy.
|
Drug: Carboplatin Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed Drug: Paclitaxel |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02477826
Show 261 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 261 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02477826 History of Changes |
| Other Study ID Numbers: |
CA209-227 2014-003630-23 ( EudraCT Number ) |
| Study First Received: | June 18, 2015 |
| Last Updated: | April 18, 2017 |
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 |
ClinicalTrials.gov processed this record on August 18, 2017