Lung Cancer Clinical Trial

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

Summary

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.

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Full Description

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%).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must have histologically or cytologically confirmed WT NSCLC that is stage IV / metastatic or recurrent
Participants with tumor tissue high expression of PD-L1 as defined by Tumor Proportion Score (TPS) ≥ 50%
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participants with measurable disease by spiral CT or MRI per RECIST v.1.1 criteria.
Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization.
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:

Participants with active central nervous system (CNS) metastases or carcinomatous meningitis
Participants with any serious or uncontrolled medical disorder or active infection with the hepatitis virus or the human immunodeficiency virus (HIV)
Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue prior to randomization
Participants that have received pembrolizumab
Participants with a history of severe hypersensitivity reactions to monoclonal antibodies
Pregnant or lactating women
Participants receiving any investigational agent within 28 days of first administration of trial treatment
Participants that have received therapy with anti-tumor vaccines or other immunostimulatory antitumor agents
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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

101

Study ID:

NCT03382899

Recruitment Status:

Terminated

Sponsor:

Eli Lilly and Company

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There are 73 Locations for this study

See Locations Near You

CCI - Clearview Cancer Institute
Huntsville Alabama, 35805, United States
Arizona Oncology Associates, P.C.
Tempe Arizona, 85284, United States
Beverly Hills Cancer Center
Beverly Hills California, 90211, United States
St. Joseph Heritage Medical Group
Fullerton California, 92835, United States
Glendale Adventist Medical Center
Los Angeles California, 90017, United States
Redlands Community Hospital
Redlands California, 92373, United States
Redwood Regional Oncology Center
Santa Rosa California, 95403, United States
The Oncology Institute of Hope and Innovation
Whittier California, 90602, United States
Memorial Hospital
Colorado Springs Colorado, 80909, United States
Kaiser Permanente Oncology Clinic
Denver Colorado, 80205, United States
Rocky Mountain Cancer Center
Lone Tree Colorado, 80124, United States
Veterans Affairs Connecticut Healthcare System
West Haven Connecticut, 06516, United States
Medical Oncology Hematolgy Consultants, PA
Newark Delaware, 19713, United States
Lynn Cancer Institute Ctr for Hem-Onc
Boca Raton Florida, 33486, United States
Memorial Cancer Institute
Pembroke Pines Florida, 33028, United States
SCRI- Florida Cancer Specialists
Tallahassee Florida, 32308, United States
Tallahassee Memorial Cancer Center
Tallahassee Florida, 32308, United States
Florida Cancer Specialists East
West Palm Beach Florida, 33401, United States
Northeast Georgia Cancer Care, LLC
Athens Georgia, 30607, United States
Pacific Diabetes & Endocrine Center
Honolulu Hawaii, 96813, United States
AMITA Health Cancer Institute & Outpatient Center
Hinsdale Illinois, 60521, United States
Orchard Healthcare Research Inc
Skokie Illinois, 60077, United States
Goshen Health System
Goshen Indiana, 46526, United States
University of Iowa
Iowa City Iowa, 52242, United States
Covenant Clinic
Waterloo Iowa, 50702, United States
Menorah Medical Center
Overland Park Kansas, 66209, United States
Baptist Health Medical Group
Lexington Kentucky, 40503, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
MedStar Research Institute
Baltimore Maryland, 21237, United States
Maryland Oncology Hematology, P.A.
Columbia Maryland, 21044, United States
Frederick Memorial Hospital
Frederick Maryland, 21701, United States
St. Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Henry Ford Hospital Detroit
Detroit Michigan, 48202, United States
Sparrow Health System
Lansing Michigan, 48912, United States
Minnesota Oncology/Hematology PA
Minneapolis Minnesota, 55404, United States
University of Minnesota Hospital
Minneapolis Minnesota, 55455, United States
Hattiesburg Clinic
Hattiesburg Mississippi, 39401, United States
St John's Mercy Medical Center
Saint Louis Missouri, 63141, United States
Nebraska Hematology-Oncology
Lincoln Nebraska, 68506, United States
Morristown Medical Center
Morristown New Jersey, 07962, United States
The Valley Hospital - Luckow Pavilion
Westwood New Jersey, 07675, United States
Clinical Research Alliance, Inc.
Lake Success New York, 11042, United States
Winthrop University Hospital
Mineola New York, 11501, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, United States
DJL Clinical Research, PLLC
Charlotte North Carolina, 28207, United States
Southeastern Medical Oncology Center
Jacksonville North Carolina, 28546, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
Christ Hospital
Cincinnati Ohio, 45219, United States
University of Toledo Medical Center
Toledo Ohio, 43614, United States
The Toledo Clinic
Toledo Ohio, 43623, United States
Oncology Associates of Oregon
Eugene Oregon, 97401, United States
Charleston Hematology Oncology Associates
Charleston South Carolina, 29414, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Chattanooga Oncology Hematology Associates
Chattanooga Tennessee, 37404, United States
Thompson Cancer Survival Center
Knoxville Tennessee, 37916, United States
Sarah Cannon Research Institute SCRI
Nashville Tennessee, 37203, United States
Texas Cancer Center (Abilene)
Abilene Texas, 79606, United States
Mamie McFaddin Ward Cancer Center
Beaumont Texas, 77702, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas Texas, 75231, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Texas Oncology-Memorial City
Houston Texas, 77024, United States
Millennium Oncology
Houston Texas, 77090, United States
Joe Arrington Cancer Center
Lubbock Texas, 79410, United States
Texas Oncology - Midland Allison Cancer Center
Midland Texas, 79701, United States
Texas Oncology-Sherman
Sherman Texas, 75090, United States
US Oncology
The Woodlands Texas, 77380, United States
Texas Oncology - Tyler
Tyler Texas, 75702, United States
Texas Oncology-Deke Slayton Cancer Center
Webster Texas, 77598, United States
Texas Oncology-Wichital Falls Texoma Cancer Center
Wichita Falls Texas, 76310, United States
Fairfax Northern Virginia Hematology Oncology, PC
Fairfax Virginia, 22031, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Roanoke Virginia, 24014, United States
Shenandoah Oncology, P.C.
Winchester Virginia, 22601, United States
MultiCare Regional Cancer Center - Auburn
Tacoma Washington, 98002, United States
The Richland Hospital
Waukesha Wisconsin, 53188, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

101

Study ID:

NCT03382899

Recruitment Status:

Terminated

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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