Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
NCT ID: NCT03382899
Last Updated: 2021-01-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
101 participants
INTERVENTIONAL
2018-03-19
2020-03-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pegilodecakin + Pembrolizumab
Participants received pegilodecakin subcutaneously (SQ) at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (\>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm.
Pembrolizumab administered as an intravenous (IV) infusion at 200 mg on Day 1 of a 21-day cycle.
Pegilodecakin
Pegilodecakin plus Pembrolizumab
Pembrolizumab
Pembrolizumab Alone
Pembrolizumab
Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Pembrolizumab
Pembrolizumab Alone
Interventions
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Pegilodecakin
Pegilodecakin plus Pembrolizumab
Pembrolizumab
Pembrolizumab Alone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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ARMO BioSciences
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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CCI - Clearview Cancer Institute
Huntsville, Alabama, United States
Arizona Oncology Associates, P.C.
Tempe, Arizona, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
St. Joseph Heritage Medical Group
Fullerton, California, United States
Glendale Adventist Medical Center
Los Angeles, California, United States
Redlands Community Hospital
Redlands, California, United States
Redwood Regional Oncology Center
Santa Rosa, California, United States
The Oncology Institute of Hope and Innovation
Whittier, California, United States
Memorial Hospital
Colorado Springs, Colorado, United States
Kaiser Permanente Oncology Clinic
Denver, Colorado, United States
Rocky Mountain Cancer Center
Lone Tree, Colorado, United States
Veterans Affairs Connecticut Healthcare System
West Haven, Connecticut, United States
Medical Oncology Hematolgy Consultants, PA
Newark, Delaware, United States
Lynn Cancer Institute Ctr for Hem-Onc
Boca Raton, Florida, United States
Memorial Cancer Institute
Pembroke Pines, Florida, United States
SCRI- Florida Cancer Specialists
Tallahassee, Florida, United States
Tallahassee Memorial Cancer Center
Tallahassee, Florida, United States
Florida Cancer Specialists East
West Palm Beach, Florida, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States
AMITA Health Cancer Institute & Outpatient Center
Hinsdale, Illinois, United States
Orchard Healthcare Research Inc
Skokie, Illinois, United States
Goshen Health System
Goshen, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Covenant Clinic
Waterloo, Iowa, United States
Menorah Medical Center
Overland Park, Kansas, United States
Baptist Health Medical Group
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
MedStar Research Institute
Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Frederick Memorial Hospital
Frederick, Maryland, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Henry Ford Hospital Detroit
Detroit, Michigan, United States
Sparrow Health System
Lansing, Michigan, United States
Minnesota Oncology/Hematology PA
Minneapolis, Minnesota, United States
University of Minnesota Hospital
Minneapolis, Minnesota, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
St John's Mercy Medical Center
St Louis, Missouri, United States
Nebraska Hematology-Oncology
Lincoln, Nebraska, United States
Morristown Medical Center
Morristown, New Jersey, United States
The Valley Hospital - Luckow Pavilion
Westwood, New Jersey, United States
Clinical Research Alliance, Inc.
Lake Success, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
Southeastern Medical Oncology Center
Jacksonville, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Christ Hospital
Cincinnati, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
The Toledo Clinic
Toledo, Ohio, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
Texas Cancer Center (Abilene)
Abilene, Texas, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology-Memorial City
Houston, Texas, United States
Millennium Oncology
Houston, Texas, United States
Joe Arrington Cancer Center
Lubbock, Texas, United States
Texas Oncology - Midland Allison Cancer Center
Midland, Texas, United States
Texas Oncology-Sherman
Sherman, Texas, United States
US Oncology
The Woodlands, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Texas Oncology-Deke Slayton Cancer Center
Webster, Texas, United States
Texas Oncology-Wichital Falls Texoma Cancer Center
Wichita Falls, Texas, United States
Fairfax Northern Virginia Hematology Oncology, PC
Fairfax, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Roanoke, Virginia, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, United States
MultiCare Regional Cancer Center - Auburn
Tacoma, Washington, United States
The Richland Hospital
Waukesha, Wisconsin, United States
Countries
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References
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Spigel D, Jotte R, Nemunaitis J, Shum M, Schneider J, Goldschmidt J, Eisenstein J, Berz D, Seneviratne L, Socoteanu M, Bhanderi V, Konduri K, Xia M, Wang H, Hozak RR, Gueorguieva I, Ferry D, Gandhi L, Chao BH, Rybkin I. Randomized Phase 2 Studies of Checkpoint Inhibitors Alone or in Combination With Pegilodecakin in Patients With Metastatic NSCLC (CYPRESS 1 and CYPRESS 2). J Thorac Oncol. 2021 Feb;16(2):327-333. doi: 10.1016/j.jtho.2020.10.001. Epub 2020 Nov 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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J1L-AM-JZGC
Identifier Type: OTHER
Identifier Source: secondary_id
AM0010-201
Identifier Type: OTHER
Identifier Source: secondary_id
17160
Identifier Type: -
Identifier Source: org_study_id
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