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
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/27/2018 |
Start Date: | October 20, 2016 |
End Date: | December 31, 2023 |
Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: |
Email: | Clinical.Trials@bms.com |
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
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
Nivolumab+Ipilimumab is effective in the treatment of patients with EGFR mutation, T790M
negative NSCLC who failed first line (1L) EGFR TKI therapy
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
We found this trial at
19
sites
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-632-2366
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5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Phone: 773-702-1280
University of Chicago One of the world's premier academic and research institutions, the University of...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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100 Medical Plaza Driveway
Los Angeles, California 90095
Los Angeles, California 90095
Phone: 310-582-4060
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333 Cedar St
New Haven, Connecticut 06504
New Haven, Connecticut 06504
(203) 432-4771
Phone: 203-737-2015
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
(801) 585-0303
Phone: 801-587-4567
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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