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

Use our guide to learn which trials are right for you!

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
1329 Lusitana Street
Honolulu, Hawaii 96813
Principal Investigator: David Tamura, MD
Phone: 808-748-7834
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
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...
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Abilene, Texas 79606
Principal Investigator: Anton Melnyk, MD
Phone: 325-692-0188
?
mi
from
Abilene, TX
Click here to add this to my saved trials
Amarillo, Texas 79106
Principal Investigator: Leonardo Forero, MD
Phone: 806-358-8654
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Arlington, Texas 76014
Principal Investigator: Scott Fleischauer, MD
Phone: 817-467-6092
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Athens, Georgia 30607
Principal Investigator: Petros Nikolinakos, MD
Phone: 706-353-2990
?
mi
from
Athens, GA
Click here to add this to my saved trials
9000 Franklin Square Drive
Baltimore, Maryland 21237
Principal Investigator: Suman Rao, MD
Phone: 443-777-8876
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Beaumont, Texas 77702
Principal Investigator: Scott McKenney, MD
Phone: 409-899-7180
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Beverly Hills, California 90211
Principal Investigator: David Berz, MD
Phone: 310-432-8934
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Blacksburg, Virginia 24060
Principal Investigator: Jerome Goldschmidt, MD
Phone: 540-381-5291
?
mi
from
Blacksburg, VA
Click here to add this to my saved trials
Canton, Ohio 44718
Principal Investigator: Nashat Y Gabrail, MD
Phone: 330-492-3345
?
mi
from
Canton, OH
Click here to add this to my saved trials
Charleston, South Carolina 29403
Principal Investigator: Gene Saylors, MD
Phone: 843-577-6957
?
mi
from
Charleston, SC
Click here to add this to my saved trials
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...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
1400 E Boulder St
Colorado Springs, Colorado 80909
Principal Investigator: Robert Hoyer, MD
Phone: 719-365-9645
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbus, Georgia 31904
Principal Investigator: Andrew Pippas, MD
Phone: 706-478-7968
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Dallas, Texas 75231
Principal Investigator: Kristi McIntyre, MD
Phone: 214-265-2080
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75246
Principal Investigator: Kartik Konduri, MD
Phone: 214-370-1000
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75203
Principal Investigator: Inna Shmerlin, MD
Phone: 214-943-9911
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80205
Principal Investigator: Jennifer Eisenstein, MD
Phone: 303-764-8523
?
mi
from
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan 48202
Principal Investigator: Igor Rybkin, MD
Phone: 313-916-3721
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Duluth, Minnesota 55805
Principal Investigator: Homam Alkaied, MD
Phone: 218-249-2567
?
mi
from
Duluth, MN
Click here to add this to my saved trials
Eugene, Oregon 97401
Principal Investigator: Matthew Lonergan, MD
Phone: 541-683-5001
?
mi
from
Eugene, OR
Click here to add this to my saved trials
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...
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Flower Mound, Texas 75028
Principal Investigator: Vibha Thomas, MD
Phone: 972-537-4100
?
mi
from
Flower Mound, TX
Click here to add this to my saved trials
Frederick, Maryland 21702
Principal Investigator: Elhamy Eskander, MD
Phone: 240-566-4941
?
mi
from
Frederick, MD
Click here to add this to my saved trials
2720 North Harbor Boulevard
Fullerton, California 92835
Principal Investigator: William Lawler, MD
Phone: 714-446-5642
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Goshen, Indiana 46526
Principal Investigator: Ebenezer A Kio, MD
Phone: 574-364-2439
?
mi
from
Goshen, IN
Click here to add this to my saved trials
Hattiesburg, Mississippi 39401
Principal Investigator: John Hrom, MD
Phone: 601-288-2495
?
mi
from
Hattiesburg, MS
Click here to add this to my saved trials
1 Salt Creek Lane
Hinsdale, Illinois 60521
Principal Investigator: Donald Sweet, MD
Phone: 630-286-5543
?
mi
from
Hinsdale, IL
Click here to add this to my saved trials
Houston, Texas 77090
Principal Investigator: Anirudha Dasgupta, MD
Phone: 877-870-2640
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77024
Principal Investigator: Muffaddal Morkas, MD
Phone: 713-467-1722
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35805
Principal Investigator: Paul Dang, MD
Phone: 703-208-9212
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Jacksonville, North Carolina 28546
Principal Investigator: Nagesh Jayaram, MD
Phone: 910-353-0824
?
mi
from
Jacksonville, NC
Click here to add this to my saved trials
Johnson City, New York 13790
Principal Investigator: Ronald Harris, MD
Phone: 607-763-6850
?
mi
from
Johnson City, NY
Click here to add this to my saved trials
1915 White Avenue
Knoxville, Tennessee 37916
Principal Investigator: Everett C Ribakove, MD
Phone: 865-331-4985
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lake Success, New York 11042
Principal Investigator: Morton Coleman, MD
Phone: 516-488-2918
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
Lansing, Michigan 48912
Principal Investigator: Gordon Srkalovic, MD
Phone: 517-364-3712
?
mi
from
Lansing, MI
Click here to add this to my saved trials
Lexington, Kentucky 40503
Principal Investigator: Firas Badin, MD
Phone: 859-260-6406
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Lincoln, Nebraska 68506
Principal Investigator: Eric Avery, MD
Phone: 402-484-4907
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Lone Tree, Colorado 80124
Principal Investigator: Robert Jotte, MD
Phone: 303-925-0700
?
mi
from
Lone Tree, CO
Click here to add this to my saved trials
Los Angeles, California 90017
Principal Investigator: Lasika Seneviratne, MD
Phone: 213-977-1214
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40207
Principal Investigator: John Hamm, MD
Phone: 319-272-2388
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lubbock, Texas 79410
Principal Investigator: Isaac Tafur, MD
Phone: 806-725-8068
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
5236 West University Drive
McKinney, Texas 75071
Principal Investigator: Monte Jones, MD
Phone: 972-542-8609
?
mi
from
McKinney, TX
Click here to add this to my saved trials
Midland, Texas 79701
Principal Investigator: David Watkins, MD
Phone: 432-687-1949
?
mi
from
Midland, TX
Click here to add this to my saved trials
120 Mineola Boulevard
Mineola, New York 11501
Principal Investigator: Jeffrey Schneider, MD
Phone: 516-663-3115
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Minneapolis, Minnesota 55405
Principal Investigator: Timothy Larson, MD
Phone: 612-884-6300
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Morristown, New Jersey 07960
Principal Investigator: Missak Haigentz, MD
Phone: 973-660-3157
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
Omaha, Nebraska 68130
Principal Investigator: Ralph Hauke, MD
Phone: 402-691-6971
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Paramus, New Jersey 07652
Principal Investigator: Eli Kirshner, MD
Phone: 201-634-5791
?
mi
from
Paramus, NJ
Click here to add this to my saved trials
Paris, Texas 75460
Principal Investigator: Sucharu Prakash, MD
Phone: 903-785-0031
?
mi
from
Paris, TX
Click here to add this to my saved trials
Pembroke Pines, Florida 33028
Principal Investigator: Luis Raez, MD
Phone: 954-844-9132
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Redlands, California 92373
Principal Investigator: Emad Ibrahim, MD
Phone: 909-478-7973
?
mi
from
Redlands, CA
Click here to add this to my saved trials
Rockville, Maryland 20850
Principal Investigator: Nicholas Farrell, MD
Phone: 301-424-6231
?
mi
from
Rockville, MD
Click here to add this to my saved trials
Sacramento, California 95816
Principal Investigator: Deepti Behl, MD
Phone: 916-454-6931
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
2130 Northeast Interstate 410 Loop
San Antonio, Texas 78217
Principal Investigator: Raul Portillo, MD
Phone: 210-224-6531
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Santa Rosa, California 95403
Principal Investigator: Ian Anderson, MD
Phone: 707-521-3830
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
Skokie, Illinois 60076
Principal Investigator: Ira Oliff, MD
Phone: 224-534-7580
?
mi
from
Skokie, IL
Click here to add this to my saved trials
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...
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Tacoma, Washington 98405
Principal Investigator: Nehal Masood, MD
Phone: 253-403-3321
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tallahassee, Florida 32308
Principal Investigator: Karen Russell, MD
Phone: 850-431-0673
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Tempe, Arizona 85284
Principal Investigator: Abhimanyu Ghose, MD
Phone: 480-256-1664
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
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....
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Toledo, Ohio 43623
Principal Investigator: Rex Mowat, MD
Phone: 419-214-4236
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Tyler, Texas 75702
Principal Investigator: Matei Socoteanu, MD
Phone: 903-579-9800
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Vancouver, Washington 98684
Principal Investigator: David Smith, MD
Phone: 360-449-6521
?
mi
from
Vancouver, WA
Click here to add this to my saved trials
Waco, Texas 76712
Principal Investigator: Carlos Encarnacion, MD
Phone: 254-399-0741
?
mi
from
Waco, TX
Click here to add this to my saved trials
Waterloo, Iowa 50702
Principal Investigator: Mohammed Masri, MD
Phone: 319-272-2388
?
mi
from
Waterloo, IA
Click here to add this to my saved trials
Waukesha, Wisconsin 53188
Principal Investigator: Timothy Wassenaar, MD
Phone: 262-928-5539
?
mi
from
Waukesha, WI
Click here to add this to my saved trials
Weslaco, Texas 78596
Principal Investigator: Habib Ghaddar, MD
Phone: 956-969-0021
?
mi
from
Weslaco, TX
Click here to add this to my saved trials
Whittier, California 90603
Principal Investigator: Merrill K Shum, M.D.
Phone: 562-693-4477
?
mi
from
Whittier, CA
Click here to add this to my saved trials
Wichita Falls, Texas 76310
Principal Investigator: Brian Ulrich, MD
Phone: 940-691-8271
?
mi
from
Wichita Falls, TX
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
Principal Investigator: Franklin Chen, MD
Phone: 336-718-8335
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials