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
Houston, Texas 77090
Principal Investigator: Anirudha Dasgupta
Phone: 281-298-8444
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Abilene, Texas 79701
Principal Investigator: Anton Melnyk
Phone: 325-692-0188
Click here to add this to my saved trials
Ann Arbor, Michigan 48197
Principal Investigator: Philip J Stella
Phone: 734-712-1000
Click here to add this to my saved trials
Click here to add this to my saved trials
Baltimore, Maryland 21237
Principal Investigator: Suman Rao
Phone: 573-458-6363
Click here to add this to my saved trials
Beaumont, Texas 77702
Principal Investigator: Scott A McKenney
Phone: 409-899-7180
Click here to add this to my saved trials
Beverly Hills, California 90211
Principal Investigator: David Berz
Phone: 310-432-8941
Click here to add this to my saved trials
Boca Raton, Florida 33486
Principal Investigator: Edgardo S Santos
Phone: 561-955-5966
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Charleston, South Carolina 29403
Principal Investigator: Brian M Lingerfelt
Phone: 843-577-6957
Click here to add this to my saved trials
Charlotte, North Carolina 28210
Principal Investigator: Justin Favaro
Phone: 704-342-1900
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
Principal Investigator: Davey Benjamin Daniel
Phone: 14236981844
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Colorado Springs, Colorado 80909
Principal Investigator: Robert Hoyer
Phone: 719-365-6568
Click here to add this to my saved trials
Columbia, Maryland 21044
Principal Investigator: Nicholas J Farrell
Phone: 301-424-6231
Click here to add this to my saved trials
Dallas, Texas 75231
Principal Investigator: Kristi J McIntyre
Phone: 214-265-2080
Click here to add this to my saved trials
Dallas, Texas 75246
Principal Investigator: Kartik Konduri
Phone: 214-370-1000
Click here to add this to my saved trials
Denver, Colorado 80205
Principal Investigator: Jennifer L Eisenstein
Click here to add this to my saved trials
Detroit, Michigan 48202
Principal Investigator: Igor I Rybkin
Phone: 313161784
Click here to add this to my saved trials
Eugene, Oregon 97401
Principal Investigator: Marc Uemura
Phone: 541-683-5001
Click here to add this to my saved trials
Fairfax, Virginia 22031
Principal Investigator: Alexander I Spira
Phone: 703-280-5390
Click here to add this to my saved trials
Frederick, Maryland 21701
Principal Investigator: Elhamy D. Eskander
Phone: 301-662-8477
Click here to add this to my saved trials
Fullerton, California 92835
Principal Investigator: William E Lawler
Phone: 714-446-5801
Click here to add this to my saved trials
200 High Park Avenue
Goshen, Indiana 46526
Goshen, Indiana 46526
Principal Investigator: Ebenezer A. Kio
Phone: 574-364-2888
Click here to add this to my saved trials
Hattiesburg, Mississippi 39401
Principal Investigator: John S Hrom
Phone: 601-261-1700
Click here to add this to my saved trials
1 Salt Creek Lane
Hinsdale, Illinois 60521
Hinsdale, Illinois 60521
Principal Investigator: Donald Sweet
Phone: 630-286-5500
Click here to add this to my saved trials
Honolulu, Hawaii 96813
Principal Investigator: David J Tamura
Phone: 808-524-6115
Click here to add this to my saved trials
Houston, Texas 77024
Principal Investigator: Muffaddal Morkas
Phone: 713-467-1722
Click here to add this to my saved trials
Huntsville, Alabama 35805
Principal Investigator: Surrinder Paul Dang
Phone: 12567054224
Click here to add this to my saved trials
Jacksonville, North Carolina 28546
Principal Investigator: Nagesh H Jayaram
Phone: 910-353-0824
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Lake Success, New York 11042
Principal Investigator: Morton Coleman
Phone: 516-488-2918
Click here to add this to my saved trials
Lansing, Michigan 48909
Principal Investigator: Gordan Srkalovic
Phone: 517-364-9402
Click here to add this to my saved trials
166 Pasadena Drive
Lexington, Kentucky 40503
Lexington, Kentucky 40503
Principal Investigator: Firas B Badin
Phone: 859-260-6456
Click here to add this to my saved trials
Lincoln, Nebraska 68506
Principal Investigator: Eric J Avery
Phone: 402-484-4900
Click here to add this to my saved trials
10103 RidgeGate Parkway
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
Principal Investigator: Robert Jotte
Phone: 303-925-0700
Click here to add this to my saved trials
Los Angeles, California 90033
Principal Investigator: Lasika Seneviratne
Phone: 213-977-1214
Click here to add this to my saved trials
Louisville, Kentucky 40207
Principal Investigator: John T Hamm
Phone: 812-288-9969
Click here to add this to my saved trials
Lubbock, Texas 79410
Principal Investigator: Isaac Tafur
Phone: 806-725-8000
Click here to add this to my saved trials
Midland, Texas 79701
Principal Investigator: David L Watkins
Phone: 432-687-1949
Click here to add this to my saved trials
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,...
Click here to add this to my saved trials
Minneapolis, Minnesota 55405
Principal Investigator: Tim Larson
Phone: 612-884-6300
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
Principal Investigator: Manish Patel
Phone: 612-624-0123
Click here to add this to my saved trials
Morristown, New Jersey 07962
Principal Investigator: Missak Haigentz
Phone: 718-405-8404
Click here to add this to my saved trials
Nashville, Tennessee 37203
Principal Investigator: David R Spigel
Click here to add this to my saved trials
Newark, Delaware 19713
Principal Investigator: Michael J. Guarino
Phone: 302-366-1200
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Redlands, California 92373
Principal Investigator: Emad Ibrahim
Phone: 909-478-7973
Click here to add this to my saved trials
Roanoke, Virginia 24014
Principal Investigator: Jerome H Goldschmidt Jr.
Phone: 276-228-7665
Click here to add this to my saved trials
621 South New Ballas Road
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Principal Investigator: Bethany Sleckman
Phone: 314-251-4400
Click here to add this to my saved trials
Santa Rosa, California 95403
Principal Investigator: Ian C Anderson
Phone: 707-521-3814
Click here to add this to my saved trials
Sherman, Texas 75090
Principal Investigator: Tammy E Roque
Phone: 903-892-9455
Click here to add this to my saved trials
Skokie, Illinois 60076
Principal Investigator: Ira A Oliff
Phone: 224-534-7580
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Tacoma, Washington 98002
Principal Investigator: Nehal Masood
Phone: 253-403-1677
Click here to add this to my saved trials
Tallahassee, Florida 32308
Principal Investigator: Karen Russell
Phone: 850-431-5360
Click here to add this to my saved trials
Tallahassee, Florida 32308
Principal Investigator: Viralkumar Bhanderi
Click here to add this to my saved trials
Tempe, Arizona 85284
Principal Investigator: Abhimanyu Ghose
Phone: 480-256-1664
Click here to add this to my saved trials
Toledo, Ohio 43614
Principal Investigator: John J. Nemunaitis
Phone: 419-383-3491
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Waukesha, Wisconsin 53188
Principal Investigator: Timothy Wassenaar
Phone: 262-928-2570
Click here to add this to my saved trials
Webster, Texas 77598
Principal Investigator: Anish Meerasahib
Phone: 281-332-7505
Click here to add this to my saved trials
West Haven, Connecticut 06516
Principal Investigator: Herta Chao
Phone: 120393257115692
Click here to add this to my saved trials
West Palm Beach, Florida 33401
Principal Investigator: Neal Rothschild
Click here to add this to my saved trials
Westwood, New Jersey 07675
Principal Investigator: Eli Kirshner
Phone: 201-634-5792
Click here to add this to my saved trials
Whittier, California 90606
Principal Investigator: Merrill K Shum
Phone: 562-693-4477
Click here to add this to my saved trials
Wichita Falls, Texas 76310
Principal Investigator: Brian Kent Ulrich
Phone: 9406918271
Click here to add this to my saved trials
Winchester, Virginia 22601
Principal Investigator: William A. Houck
Phone: 540-662-1108
Click here to add this to my saved trials