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.
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%).
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
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There are 73 Locations for this study
Huntsville Alabama, 35805, United States
Tempe Arizona, 85284, United States
Beverly Hills California, 90211, United States
Fullerton California, 92835, United States
Los Angeles California, 90017, United States
Redlands California, 92373, United States
Santa Rosa California, 95403, United States
Whittier California, 90602, United States
Colorado Springs Colorado, 80909, United States
Denver Colorado, 80205, United States
Lone Tree Colorado, 80124, United States
West Haven Connecticut, 06516, United States
Newark Delaware, 19713, United States
Boca Raton Florida, 33486, United States
Pembroke Pines Florida, 33028, United States
Tallahassee Florida, 32308, United States
Tallahassee Florida, 32308, United States
West Palm Beach Florida, 33401, United States
Athens Georgia, 30607, United States
Honolulu Hawaii, 96813, United States
Hinsdale Illinois, 60521, United States
Skokie Illinois, 60077, United States
Goshen Indiana, 46526, United States
Iowa City Iowa, 52242, United States
Waterloo Iowa, 50702, United States
Overland Park Kansas, 66209, United States
Lexington Kentucky, 40503, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21237, United States
Columbia Maryland, 21044, United States
Frederick Maryland, 21701, United States
Ann Arbor Michigan, 48106, United States
Detroit Michigan, 48202, United States
Lansing Michigan, 48912, United States
Minneapolis Minnesota, 55404, United States
Minneapolis Minnesota, 55455, United States
Hattiesburg Mississippi, 39401, United States
Saint Louis Missouri, 63141, United States
Lincoln Nebraska, 68506, United States
Morristown New Jersey, 07962, United States
Westwood New Jersey, 07675, United States
Lake Success New York, 11042, United States
Mineola New York, 11501, United States
Stony Brook New York, 11794, United States
Charlotte North Carolina, 28207, United States
Jacksonville North Carolina, 28546, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45219, United States
Toledo Ohio, 43614, United States
Toledo Ohio, 43623, United States
Eugene Oregon, 97401, United States
Charleston South Carolina, 29414, United States
Sioux Falls South Dakota, 57105, United States
Chattanooga Tennessee, 37404, United States
Knoxville Tennessee, 37916, United States
Nashville Tennessee, 37203, United States
Abilene Texas, 79606, 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
Sherman Texas, 75090, United States
The Woodlands Texas, 77380, United States
Tyler Texas, 75702, United States
Webster Texas, 77598, United States
Wichita Falls Texas, 76310, United States
Fairfax Virginia, 22031, United States
Roanoke Virginia, 24014, United States
Winchester Virginia, 22601, United States
Tacoma Washington, 98002, United States
Waukesha Wisconsin, 53188, United States
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