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.
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%).
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
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There are 35 Locations for this study
Tempe Arizona, 85284, United States
Beverly Hills California, 90211, United States
Los Angeles California, 90017, United States
Santa Rosa California, 95403, United States
Whittier California, 90602, United States
Lone Tree Colorado, 80124, United States
Columbus Georgia, 31904, United States
Waterloo Iowa, 50702, United States
Lexington Kentucky, 40503, United States
Baltimore Maryland, 21237, United States
Columbia Maryland, 21044, United States
Frederick Maryland, 21701, United States
Lansing Michigan, 48912, United States
Hattiesburg Mississippi, 39401, United States
Westwood New Jersey, 07675, United States
Johnson City New York, 13790, United States
Mineola New York, 11501, United States
New Hyde Park New York, 11042, United States
Stony Brook New York, 11794, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45219, United States
Toledo Ohio, 43614, United States
Charleston South Carolina, 29414, United States
Beaumont Texas, 77702, United States
Dallas Texas, 75231, United States
Dallas Texas, 75246, United States
Houston Texas, 77024, United States
Houston Texas, 77090, United States
Lubbock Texas, 79410, United States
Midland Texas, 79701, United States
The Woodlands Texas, 77380, United States
Tyler Texas, 75702, United States
Fairfax Virginia, 22031, United States
Roanoke Virginia, 24014, United States
Tacoma Washington, 98002, United States
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