A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:January 13, 2017
End Date:November 8, 2028
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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Trial Summary
Trial Overview
Inclusion Criteria

Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and
chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus
ipilimumab's safety and effectiveness in treating resectable NSCLC.

This study has multiple primary endpoints.

The first primary completion date of Pathological Complete Response is anticipated to be
reached April 2020.

The completion date for all primary outcome measures is expected May 2023.


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue

- Lung function capacity capable of tolerating the proposed lung surgery

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

- Available tissue of primary lung tumor

Exclusion Criteria:

- Presence of locally advanced, inoperable or metastatic disease

- Participants with active, known or suspected autoimmune disease

- Prior treatment with any drug that targets T cell co-stimulations pathways (such as
checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
77
sites
University of Kentucky
Lexington, Kentucky
859) 257-9000
Phone: 859-218-6145
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21231
410-955-6190
Phone: 410-502-8737
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Baltimore, MD
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Beth Israel Deaconess Medical Center
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-632-3468
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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Fort Wayne Medical Oncology and Hematology
11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
(260) 484-8830
Phone: 260-969-7876
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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Fort Wayne, IN
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-322-4967
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Orlando Health
24 Sturtevant St
Orlando, Florida 32806
Phone: 321-841-3812
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Orlando, FL
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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-418-9389
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Indian River Med. Ctr.
1000 36th Street
Vero Beach, Florida 32960
Phone: 772-226-4960
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Vero Beach, FL
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Local Institution
Athens, Georgia 30607
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Texas Oncology, PA at South Austin Cancer Center
Austin, Texas 78745
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Medstar Franklin Sqaure Medical Center
Baltimore, Maryland 21237
Phone: 443-777-7364
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Texas Oncology, P.A.
Bedford, Texas 76022
Phone: 817-359-9000
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St. Vincent Frontier Cancer Center
Billings, Montana 59102
Phone: 406-238-6290
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Dana-Farber Cancer Institute
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-4767
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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The University of Vermont Cancer Center
Burlington, Vermont 05405
Phone: 802-656-9916
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Instituto Medico Especializado Alexander Fleming
Capital Federal, Buenos Aires
Phone: +541132218956
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Charleston Hematology/Oncology Associates, Pa
Charleston, South Carolina 29403
Phone: 843-577-6957
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-4421
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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University of Chicago Medical Center
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Phone: 773-702-1280
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Northwestern Medicine
Chicago, Illinois 60611
Phone: 312-695-4781
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The Christ Hospital
2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Phone: 513-451-4033
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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MetroHealth Med Ctr
2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Phone: 216-778-3526
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Local Institution
Columbia, Missouri 65212
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University of Miami
Deerfield Beach, Florida 33442
Phone: 954-698-3616
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Rocky Mountain Cancer Center
Denver, Colorado 80218
Phone: 303-285-5081
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Henry Ford Health System
Detroit, Michigan 48202
Phone: 313-916-0482
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Detroit, MI
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WBAMC Oncology Department
El Paso, Texas 79920
Phone: 915-742-3432
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Local Institution
Elizabethtown, Kentucky 42701
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Virginia Cancer Specialists, PC
8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Phone: 703-208-3173
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Local Institution
32 Washington Street
Fairhaven, Massachusetts 02719
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Fairhaven, MA
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Local Institution
Fort Gordon, Georgia 30905
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Local Institution
Fort Worth, Texas 76164
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Local Institution
Fredericksburg, Virginia 22408
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Bon Secours St. Francis Hospital
Greenville, South Carolina 29601
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The Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey
Phone: 551-996-8066
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Hattiesburg Clinic
Hattiesburg, Mississippi 39401
Phone: 601-288-2495
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Hattiesburg, MS
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Local Institution
High Point, North Carolina 27262
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Memorial Regional Hospital
Hollywood, Florida 33021
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Hollywood, FL
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Local Institution
Houston, Texas 77030
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Millenium Oncology
Houston, Texas 77090
Phone: 877-870-2640
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Houston, TX
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New York Oncology Hematology, Pc
Irving, Texas 75063
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Irving, TX
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Local Institution
Jacksonville, Florida 32256
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Comprehensive Cancer Centers of Nevada
9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Los Angeles Hematology/Oncology Medical Group
Los Angeles, California 90017
Phone: 213-977-1214
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Los Angeles, CA
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Local Institution
Los Angeles, California 90095
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Local Institution
Louisville, Kentucky 40202
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Local Institution
Lubbock, Texas
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Northwest Georgia Oncology Center
Marietta, Georgia 30060
Phone: 770-333-2161
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Intermountain Medical Center
5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Phone: 801-507-3950
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Tennessee Oncology, PLLC
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Phone: 615-329-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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University Medical Center New Orleans
New Orleans, Louisiana 70112
Phone: 504-702-5171
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New Orleans, LA
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Local Institution
New York, New York 10016
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Laura And Isaac Perlmutter Cancer Center
New York, New York 10016
Phone: 212-263-8696
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Illinois Cancer Specialists
Niles, Illinois 60714
Phone: 847-827-9060
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Cancer Institute Of Florida
Orlando, Florida 32804
Phone: 407-303-2523
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Local Institution
Philadelphia, Pennsylvania 19102
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Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Phone: 215-214-3789
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Arizona Oncology Assoc, Pc-Hal
Phoenix, Arizona 85016
Phone: 602-277-4868
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Local Institution
Phoenix, Arizona 85016
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Local Institution
Pittsburgh, Pennsylvania 15240
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Allegheny General Hospital
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Phone: 412-578-1364
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Cancer Center of Central Connecticut
Plainville, Connecticut
Phone: 860-224-4408
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Plainville, CT
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Local Institution
Portland, Oregon 97201
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Local Institution
Sacramento, California 95819
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Local Institution
1506 South Silicon Way
Saint George, Utah 84770
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Southwest Regional Cancer Clinic
544 South 400 East
Saint George, Utah 84770
Phone: 435-688-4168
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Huntsman Cancer Institute
Salt Lake City, Utah 84112
Phone: 801-587-4368
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Salt Lake City, UT
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Local Institution
Santa Barbara, California 93105
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Local Institution
Santa Rosa, California 95403
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Texas Cancer Center - Sherman
Sherman, Texas 75090
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Local Institution
8007 183rd Street
Tinley Park, Illinois 60487
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HOPE Cancer Center of East Texas
721 Clinic Drive
Tyler, Texas 75701
Phone: 903-595-7045
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Tyler, TX
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Texas Oncology
Waco, Texas 76712
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Valley Hospital Luckow Pavili
1 Valley Health Plaza
Westwood, New Jersey 07675
Phone: 201-634-5792
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Local Institution
Wichita, Kansas 67214
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Local Institution
Worcester, Massachusetts 01608
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Genesis Health Care System
740 Adair Avenue
Zanesville, Ohio 43701
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