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

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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


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
11 Fucheng Road
Beijing, Beijing 10002
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Beijing,
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-632-2366
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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5801 South Ellis Avenue
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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Chicago, IL
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Fort Worth, Texas 76107
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Fort Worth, TX
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Long Beach, California 90813
Phone: 562-590-0345
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Long Beach, CA
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Los Angeles, California 90017
Phone: 213-977-1214
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Los Angeles, CA
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100 Medical Plaza Driveway
Los Angeles, California 90095
Phone: 310-582-4060
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Los Angeles, CA
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333 Cedar St
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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New Haven, CT
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New York, New York 10016
Phone: 929-455-2436
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New York, NY
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Orange, California 92868
Phone: 714-734-6200
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Orange, CA
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Philadelphia, Pennsylvania 19111
Phone: 215-214-1736
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Philadelphia, PA
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Redondo Beach, California 90277
Phone: 310-750-3382
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Redondo Beach, CA
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2000 Circle of Hope Dr
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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Salt Lake City, UT
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Temple, Texas 76508
Phone: 254-724-5889
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Tyler, Texas 75701
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