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



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:March 19, 2018
End Date:March 25, 2022
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:Clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

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A Randomized Phase 2 Trial of AM0010 in Combination With Pembrolizumab vs. Pembrolizumab Alone as First-Line (1L) Therapy in Patients With Stage IV / Metastatic Wild Type (WT) Non-Small Cell Lung Cancer and Tumors With High Expression of PD-L1 (> 50%)

To compare the efficacy of pegilodecakin in combination with pembrolizumab versus
pembrolizumab 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 pembrolizumab versus pembrolizumab
alone in participants with stage IV / metastatic wild type non-small cell lung cancer and
tumors with high expression of PD-L1 (> 50%).

Inclusion Criteria:

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

2. Participants with tumor tissue high expression of PD-L1 as defined by Tumor Proportion
Score (TPS) ≥ 50%

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

4. Participants with measurable disease by spiral CT or MRI per RECIST v.1.1 criteria.

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

6. Participants must be naïve to therapy for the advanced stage of the disease. Previous
neoadjuvant or adjuvant therapy is allowed for participants who successfully underwent
complete radical surgery and ONLY if the last treatment was administered more than 12
months prior to the start of the trial treatment

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 pembrolizumab

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

6. Pregnant or lactating women

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

8. Participants that have received therapy with anti-tumor vaccines or other
immunostimulatory antitumor agents

9. 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
We found this trial at
73
sites
2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Manish Bhandari
Phone: 513-585-1496
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Muhammad Furqan
Phone: 319-356-1527
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Principal Investigator: Mark R Huber
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 79701
Principal Investigator: Anton Melnyk
Phone: 325-692-0188
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Ann Arbor, Michigan 48197
Principal Investigator: Philip J Stella
Phone: 734-712-1000
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Athens, Georgia 30607
Principal Investigator: Petros G Nikolinakos
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Baltimore, Maryland 21237
Principal Investigator: Suman Rao
Phone: 573-458-6363
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Beaumont, Texas 77702
Principal Investigator: Scott A McKenney
Phone: 409-899-7180
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Beverly Hills, California 90211
Principal Investigator: David Berz
Phone: 310-432-8941
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Boca Raton, Florida 33486
Principal Investigator: Edgardo S Santos
Phone: 561-955-5966
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Principal Investigator: Nashat Y Gabrail
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Charleston, South Carolina 29403
Principal Investigator: Brian M Lingerfelt
Phone: 843-577-6957
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Charlotte, North Carolina 28210
Principal Investigator: Justin Favaro
Phone: 704-342-1900
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Chattanooga, Tennessee 37404
Principal Investigator: Davey Benjamin Daniel
Phone: 14236981844
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Colorado Springs, Colorado 80909
Principal Investigator: Robert Hoyer
Phone: 719-365-6568
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Columbia, Maryland 21044
Principal Investigator: Nicholas J Farrell
Phone: 301-424-6231
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Dallas, Texas 75231
Principal Investigator: Kristi J McIntyre
Phone: 214-265-2080
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Dallas, Texas 75246
Principal Investigator: Kartik Konduri
Phone: 214-370-1000
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Denver, Colorado 80205
Principal Investigator: Jennifer L Eisenstein
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Detroit, Michigan 48202
Principal Investigator: Igor I Rybkin
Phone: 313161784
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Eugene, Oregon 97401
Principal Investigator: Marc Uemura
Phone: 541-683-5001
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Fairfax, Virginia 22031
Principal Investigator: Alexander I Spira
Phone: 703-280-5390
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Frederick, Maryland 21701
Principal Investigator: Elhamy D. Eskander
Phone: 301-662-8477
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Fullerton, California 92835
Principal Investigator: William E Lawler
Phone: 714-446-5801
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200 High Park Avenue
Goshen, Indiana 46526
Principal Investigator: Ebenezer A. Kio
Phone: 574-364-2888
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Hattiesburg, Mississippi 39401
Principal Investigator: John S Hrom
Phone: 601-261-1700
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1 Salt Creek Lane
Hinsdale, Illinois 60521
Principal Investigator: Donald Sweet
Phone: 630-286-5500
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Honolulu, Hawaii 96813
Principal Investigator: David J Tamura
Phone: 808-524-6115
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Houston, Texas 77090
Principal Investigator: Anirudha Dasgupta
Phone: 281-298-8444
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Houston, Texas 77024
Principal Investigator: Muffaddal Morkas
Phone: 713-467-1722
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Huntsville, Alabama 35805
Principal Investigator: Surrinder Paul Dang
Phone: 12567054224
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Jacksonville, North Carolina 28546
Principal Investigator: Nagesh H Jayaram
Phone: 910-353-0824
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1915 White Ave.
Knoxville, Tennessee 37916
(865) 541-1678
Principal Investigator: Jashmin K Patel
Thompson Cancer Survival Center The Thompson Cancer Survival Center Downtown facility has pioneered many advances...
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Lake Success, New York 11042
Principal Investigator: Morton Coleman
Phone: 516-488-2918
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Lansing, Michigan 48909
Principal Investigator: Gordan Srkalovic
Phone: 517-364-9402
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166 Pasadena Drive
Lexington, Kentucky 40503
Principal Investigator: Firas B Badin
Phone: 859-260-6456
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Lincoln, Nebraska 68506
Principal Investigator: Eric J Avery
Phone: 402-484-4900
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10103 RidgeGate Parkway
Lone Tree, Colorado 80124
Principal Investigator: Robert Jotte
Phone: 303-925-0700
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Los Angeles, California 90033
Principal Investigator: Lasika Seneviratne
Phone: 213-977-1214
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Louisville, Kentucky 40207
Principal Investigator: John T Hamm
Phone: 812-288-9969
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Lubbock, Texas 79410
Principal Investigator: Isaac Tafur
Phone: 806-725-8000
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Midland, Texas 79701
Principal Investigator: David L Watkins
Phone: 432-687-1949
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259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Jeffrey Schneider
Phone: 516-663-9500
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Minneapolis, Minnesota 55405
Principal Investigator: Tim Larson
Phone: 612-884-6300
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Minneapolis, Minnesota 55455
Principal Investigator: Manish Patel
Phone: 612-624-0123
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Morristown, New Jersey 07962
Principal Investigator: Missak Haigentz
Phone: 718-405-8404
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Nashville, Tennessee 37203
Principal Investigator: David R Spigel
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Newark, Delaware 19713
Principal Investigator: Michael J. Guarino
Phone: 302-366-1200
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5721 W 119th St
Overland Park, Kansas 66209
(913) 498-6000
Principal Investigator: Joseph F Stilwill
Phone: 913-498-7409
Menorah Medical Center Menorah Medical Center (MMC), a full-service, acute care hospital located on the...
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Pembroke Pines, Florida 33025
Principal Investigator: Luis Raez
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Redlands, California 92373
Principal Investigator: Emad Ibrahim
Phone: 909-478-7973
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Roanoke, Virginia 24014
Principal Investigator: Jerome H Goldschmidt Jr.
Phone: 276-228-7665
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621 South New Ballas Road
Saint Louis, Missouri 63141
Principal Investigator: Bethany Sleckman
Phone: 314-251-4400
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Santa Rosa, California 95403
Principal Investigator: Ian C Anderson
Phone: 707-521-3814
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Sherman, Texas 75090
Principal Investigator: Tammy E Roque
Phone: 903-892-9455
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Skokie, Illinois 60076
Principal Investigator: Ira A Oliff
Phone: 224-534-7580
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Principal Investigator: Roger S Keresztes
Phone: 631-444-6708
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Tacoma, Washington 98002
Principal Investigator: Nehal Masood
Phone: 253-403-1677
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Tallahassee, Florida 32308
Principal Investigator: Karen Russell
Phone: 850-431-5360
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Tallahassee, Florida 32308
Principal Investigator: Viralkumar Bhanderi
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Tempe, Arizona 85284
Principal Investigator: Abhimanyu Ghose
Phone: 480-256-1664
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Toledo, Ohio 43614
Principal Investigator: John J. Nemunaitis
Phone: 419-383-3491
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Toledo, Ohio 43623
Principal Investigator: Rex Mowat
Phone: 419-479-5495
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Tyler, Texas 75702
Principal Investigator: Matei Socoteanu
Phone: 903-579-9800
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Waterloo, Iowa 50702
Principal Investigator: Mohammed Masri
Phone: 319-272-2070
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Waukesha, Wisconsin 53188
Principal Investigator: Timothy Wassenaar
Phone: 262-928-2570
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Webster, Texas 77598
Principal Investigator: Anish Meerasahib
Phone: 281-332-7505
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West Haven, Connecticut 06516
Principal Investigator: Herta Chao
Phone: 120393257115692
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West Palm Beach, Florida 33401
Principal Investigator: Neal Rothschild
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Westwood, New Jersey 07675
Principal Investigator: Eli Kirshner
Phone: 201-634-5792
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Whittier, California 90606
Principal Investigator: Merrill K Shum
Phone: 562-693-4477
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Wichita Falls, Texas 76310
Principal Investigator: Brian Kent Ulrich
Phone: 9406918271
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Winchester, Virginia 22601
Principal Investigator: William A. Houck
Phone: 540-662-1108
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