Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:March 22, 2018
End Date:March 25, 2022

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A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1

To compare the efficacy of pegilodecakin in combination with nivolumab versus nivolumab alone
in participants with metastatic non-small cell lung cancer as measured by objective response
rate.

This is an open-label, multi-center, randomized, Phase 2 study designed to compare the
efficacy and safety of pegilodecakin in combination with nivolumab versus nivolumab alone in
participants with stage IV / metastatic wild type non-small cell lung cancer and tumors with
low tumor expression of PD-L1 (0-49%).

Inclusion Criteria:

1. Participants must have histologically or cytologically confirmed WT NSCLC that is
stage IV / metastatic or recurrent

2. Participants must have received at least one prior systemic therapy that was not an
anti-PD-1, anti-PD-L1 and/or anti-CTLA-4 treatment for the advanced stage of the
disease

3. Participants with tumor tissue low expression of PD-L1 as defined by Tumor Proportion
Score (TPS) 0% - 49%

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

5. Participants with measurable disease by spiral computed tomography (CT) or magnetic
resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumor (RECIST) v.1.1
criteria

6. Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks
prior to randomization

Exclusion Criteria:

1. Participants with active central nervous system (CNS) metastases or carcinomatous
meningitis

2. Participants with any serious or uncontrolled medical disorder or active infection
with the hepatitis virus or the human immunodeficiency virus (HIV)

3. Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior
anti-cancer therapy (other than alopecia and fatigue) prior to randomization

4. Participants that have received nivolumab

5. Participants that have received therapy with anti-tumor vaccines or other
immuno-stimulatory antitumor agents

6. Participants with a history of severe hypersensitivity reactions to monoclonal
antibodies

7. Participants that have received therapy with anti-PD-1, anti-PD-L1, anti-PD-L-2,
anti-CD-137, and/or anti CTLA-4 antibodies

8. Participants receiving any investigational agent within 28 days of first
administration of trial treatment

9. Pregnant or lactating women
We found this trial at
73
sites
Johnson City, New York 13790
Principal Investigator: Ronald Harris, MD
Phone: 607-763-6850
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Principal Investigator: Mark Huber, MD
Phone: 605-322-3018
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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Abilene, Texas 79606
Principal Investigator: Anton Melnyk, MD
Phone: 325-692-0188
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Amarillo, Texas 79106
Principal Investigator: Leonardo Forero, MD
Phone: 806-358-8654
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Arlington, Texas 76014
Principal Investigator: Scott Fleischauer, MD
Phone: 817-467-6092
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Athens, Georgia 30607
Principal Investigator: Petros Nikolinakos, MD
Phone: 706-353-2990
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9000 Franklin Square Drive
Baltimore, Maryland 21237
Principal Investigator: Suman Rao, MD
Phone: 443-777-8876
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Beaumont, Texas 77702
Principal Investigator: Scott McKenney, MD
Phone: 409-899-7180
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Beverly Hills, California 90211
Principal Investigator: David Berz, MD
Phone: 310-432-8934
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Blacksburg, Virginia 24060
Principal Investigator: Jerome Goldschmidt, MD
Phone: 540-381-5291
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Canton, Ohio 44718
Principal Investigator: Nashat Y Gabrail, MD
Phone: 330-492-3345
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Charleston, South Carolina 29403
Principal Investigator: Gene Saylors, MD
Phone: 843-577-6957
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Manish Bhandari, MD
Phone: 513-585-1777
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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1400 E Boulder St
Colorado Springs, Colorado 80909
Principal Investigator: Robert Hoyer, MD
Phone: 719-365-9645
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Columbus, Georgia 31904
Principal Investigator: Andrew Pippas, MD
Phone: 706-478-7968
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Dallas, Texas 75231
Principal Investigator: Kristi McIntyre, MD
Phone: 214-265-2080
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Dallas, Texas 75246
Principal Investigator: Kartik Konduri, MD
Phone: 214-370-1000
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Dallas, Texas 75203
Principal Investigator: Inna Shmerlin, MD
Phone: 214-943-9911
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Denver, Colorado 80205
Principal Investigator: Jennifer Eisenstein, MD
Phone: 303-764-8523
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Detroit, Michigan 48202
Principal Investigator: Igor Rybkin, MD
Phone: 313-916-3721
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Duluth, Minnesota 55805
Principal Investigator: Homam Alkaied, MD
Phone: 218-249-2567
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Eugene, Oregon 97401
Principal Investigator: Matthew Lonergan, MD
Phone: 541-683-5001
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Timothy McCarthy, MD
Phone: 703-280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Flower Mound, Texas 75028
Principal Investigator: Vibha Thomas, MD
Phone: 972-537-4100
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Frederick, Maryland 21702
Principal Investigator: Elhamy Eskander, MD
Phone: 240-566-4941
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2720 North Harbor Boulevard
Fullerton, California 92835
Principal Investigator: William Lawler, MD
Phone: 714-446-5642
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Goshen, Indiana 46526
Principal Investigator: Ebenezer A Kio, MD
Phone: 574-364-2439
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Hattiesburg, Mississippi 39401
Principal Investigator: John Hrom, MD
Phone: 601-288-2495
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1 Salt Creek Lane
Hinsdale, Illinois 60521
Principal Investigator: Donald Sweet, MD
Phone: 630-286-5543
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1329 Lusitana Street
Honolulu, Hawaii 96813
Principal Investigator: David Tamura, MD
Phone: 808-748-7834
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Houston, Texas 77090
Principal Investigator: Anirudha Dasgupta, MD
Phone: 877-870-2640
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Houston, Texas 77024
Principal Investigator: Muffaddal Morkas, MD
Phone: 713-467-1722
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Huntsville, Alabama 35805
Principal Investigator: Paul Dang, MD
Phone: 703-208-9212
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Jacksonville, North Carolina 28546
Principal Investigator: Nagesh Jayaram, MD
Phone: 910-353-0824
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1915 White Avenue
Knoxville, Tennessee 37916
Principal Investigator: Everett C Ribakove, MD
Phone: 865-331-4985
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Lake Success, New York 11042
Principal Investigator: Morton Coleman, MD
Phone: 516-488-2918
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Lansing, Michigan 48912
Principal Investigator: Gordon Srkalovic, MD
Phone: 517-364-3712
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Lexington, Kentucky 40503
Principal Investigator: Firas Badin, MD
Phone: 859-260-6406
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Lincoln, Nebraska 68506
Principal Investigator: Eric Avery, MD
Phone: 402-484-4907
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Lone Tree, Colorado 80124
Principal Investigator: Robert Jotte, MD
Phone: 303-925-0700
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Los Angeles, California 90017
Principal Investigator: Lasika Seneviratne, MD
Phone: 213-977-1214
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Louisville, Kentucky 40207
Principal Investigator: John Hamm, MD
Phone: 319-272-2388
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Lubbock, Texas 79410
Principal Investigator: Isaac Tafur, MD
Phone: 806-725-8068
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5236 West University Drive
McKinney, Texas 75071
Principal Investigator: Monte Jones, MD
Phone: 972-542-8609
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Midland, Texas 79701
Principal Investigator: David Watkins, MD
Phone: 432-687-1949
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120 Mineola Boulevard
Mineola, New York 11501
Principal Investigator: Jeffrey Schneider, MD
Phone: 516-663-3115
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Minneapolis, Minnesota 55405
Principal Investigator: Timothy Larson, MD
Phone: 612-884-6300
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Morristown, New Jersey 07960
Principal Investigator: Missak Haigentz, MD
Phone: 973-660-3157
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Omaha, Nebraska 68130
Principal Investigator: Ralph Hauke, MD
Phone: 402-691-6971
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Paramus, New Jersey 07652
Principal Investigator: Eli Kirshner, MD
Phone: 201-634-5791
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Paris, Texas 75460
Principal Investigator: Sucharu Prakash, MD
Phone: 903-785-0031
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Pembroke Pines, Florida 33028
Principal Investigator: Luis Raez, MD
Phone: 954-844-9132
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Redlands, California 92373
Principal Investigator: Emad Ibrahim, MD
Phone: 909-478-7973
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Rockville, Maryland 20850
Principal Investigator: Nicholas Farrell, MD
Phone: 301-424-6231
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Sacramento, California 95816
Principal Investigator: Deepti Behl, MD
Phone: 916-454-6931
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2130 Northeast Interstate 410 Loop
San Antonio, Texas 78217
Principal Investigator: Raul Portillo, MD
Phone: 210-224-6531
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Santa Rosa, California 95403
Principal Investigator: Ian Anderson, MD
Phone: 707-521-3830
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Skokie, Illinois 60076
Principal Investigator: Ira Oliff, MD
Phone: 224-534-7580
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Principal Investigator: Roger Keresztes, MD
Phone: 631-638-0837
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Tacoma, Washington 98405
Principal Investigator: Nehal Masood, MD
Phone: 253-403-3321
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Tallahassee, Florida 32308
Principal Investigator: Karen Russell, MD
Phone: 850-431-0673
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Tempe, Arizona 85284
Principal Investigator: Abhimanyu Ghose, MD
Phone: 480-256-1664
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
Principal Investigator: John J Nemunaitis, MD
Phone: 419-383-6962
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
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Toledo, Ohio 43623
Principal Investigator: Rex Mowat, MD
Phone: 419-214-4236
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Tyler, Texas 75702
Principal Investigator: Matei Socoteanu, MD
Phone: 903-579-9800
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Vancouver, Washington 98684
Principal Investigator: David Smith, MD
Phone: 360-449-6521
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Waco, Texas 76712
Principal Investigator: Carlos Encarnacion, MD
Phone: 254-399-0741
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Waterloo, Iowa 50702
Principal Investigator: Mohammed Masri, MD
Phone: 319-272-2388
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Waukesha, Wisconsin 53188
Principal Investigator: Timothy Wassenaar, MD
Phone: 262-928-5539
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Weslaco, Texas 78596
Principal Investigator: Habib Ghaddar, MD
Phone: 956-969-0021
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Whittier, California 90603
Principal Investigator: Merrill K Shum, M.D.
Phone: 562-693-4477
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Wichita Falls, Texas 76310
Principal Investigator: Brian Ulrich, MD
Phone: 940-691-8271
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Winston-Salem, North Carolina 27103
Principal Investigator: Franklin Chen, MD
Phone: 336-718-8335
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