Lung Cancer Clinical Trial

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

Summary

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.

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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 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%).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must have histologically or cytologically confirmed Wild Type NSCLC that is stage IV / metastatic or recurrent
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
Participants with tumor tissue low expression of PD-L1 as defined by Tumor Proportion Score (TPS) 0% - 49%
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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
Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization

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 nivolumab
Participants that have received therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
Participants with a history of severe hypersensitivity reactions to monoclonal antibodies
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
Participants receiving any investigational agent within 28 days of first administration of trial treatment
Pregnant or lactating women

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

52

Study ID:

NCT03382912

Recruitment Status:

Terminated

Sponsor:

Eli Lilly and Company

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There are 35 Locations for this study

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Arizona Oncology Associates, P.C.
Tempe Arizona, 85284, United States
Beverly Hills Cancer Center
Beverly Hills California, 90211, United States
Glendale Adventist Medical Center
Los Angeles California, 90017, United States
Redwood Regional Oncology Center
Santa Rosa California, 95403, United States
The Oncology Institute of Hope and Innovation
Whittier California, 90602, United States
Rocky Mountain Cancer Center
Lone Tree Colorado, 80124, United States
John B. Amos Cancer Center
Columbus Georgia, 31904, United States
Covenant Clinic
Waterloo Iowa, 50702, United States
Baptist Health Medical Group
Lexington Kentucky, 40503, United States
MedStar Health 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
Sparrow Health System
Lansing Michigan, 48912, United States
Hattiesburg Clinic
Hattiesburg Mississippi, 39401, United States
The Valley Hospital - Luckow Pavilion
Westwood New Jersey, 07675, United States
Broome Oncology LLC
Johnson City New York, 13790, United States
Winthrop University Hospital
Mineola New York, 11501, United States
Clinical Research Alliance, Inc.
New Hyde Park New York, 11042, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, 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
Charleston Hematology Oncology Associates
Charleston South Carolina, 29414, 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
US Oncology
The Woodlands Texas, 77380, United States
Texas Oncology - Tyler
Tyler Texas, 75702, 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
MultiCare Regional Cancer Center - Auburn
Tacoma Washington, 98002, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

52

Study ID:

NCT03382912

Recruitment Status:

Terminated

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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