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A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Patients With EGFR Mutation, T790M Negative NSCLC Who Have Failed 1L EGFR TKI Therapy (CheckMate722)

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ClinicalTrials.gov Identifier: NCT02864251
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : September 25, 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 determine whether Nivolumab+ chemotherapy and Nivolumab+Ipilimumab is effective in the treatment of patients with EGFR mutation, T790M negative NSCLC who failed first line (1L) EGFR TKI therapy

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation, T790M Negative Who Failed 1L EGFR Tyrosine Kinase Inhibitor Therapy
Actual Study Start Date : October 20, 2016
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2023

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: Nivolumab+Platinum doublet chemotherapy
Specified dose on specified days
 Biological: Nivolumab
Other Names:
  • Opdivo
  • BMS-936558

Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin
Experimental: Nivolumab + Ipilimumab
Specified dose on specified days
 Biological: Nivolumab
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
Active Comparator: Platinum doublet chemotherapy
Specified dose on specified days
 Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival (PFS) in subjects with epidermal growth factor receptor (EGFR) mutation, T790M negative non-small cell lung carcinoma (NSCLC) [ Time Frame: up to 33 months ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 5 years ]
  2. Objective response rate (ORR) [ Time Frame: Up to 33 months ]
  3. Duration of response (DOR) [ Time Frame: Up to 33 months ]
  4. Progression free survival (PFS) rate [ Time Frame: Up to 33 months ]

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 Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Confirmed stage IV or recurrent EGFR Mutation (MT)+ NSCLC with disease progression after 1 prior EGFR TKI therapy
  • No evidence of exon 20 T790M mutation after progression on prior EGFR tyrosine kinase inhibitor(TKI) therapy.
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  • Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC) and exon 20 T790M testing

Exclusion Criteria:

  • Subjects with symptomatic central nervous system (CNS) metastases
  • Subjects with carcinomatous meningitis
  • Subjects with an active, known or suspected autoimmune disease are excluded
  • Subjects with known SCLC transformation

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): NCT02864251


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 108 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:
BMS Clinical Trial Information  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
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02864251     History of Changes
Other Study ID Numbers: CA209-722
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Nivolumab
 Carboplatin
Pemetrexed
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors