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 | 
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.
			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%).
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
	
									101 Jessup Hall
Iowa City, Iowa 52242
	
			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
	
			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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								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
	
			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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									2139 Auburn Ave
Cincinnati, Ohio 45219
	
			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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								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
	
			
					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
	
			
					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
	
			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
	
			
					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
	
			
					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
	
			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
	
			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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								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
	
			
					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
	
			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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								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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