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

Stopped early · Phase 2

Conditions studied: Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT03382912

Run by

Eli Lilly and Company

People needed

52

Starts

2018-03-22

Expected to finish

2020-03-03

Last updated by the study team

2020-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Oncology Associates, P.C. — Tempe, Arizona, United States
• Beverly Hills Cancer Center — Beverly Hills, California, United States
• Glendale Adventist Medical Center — Los Angeles, California, United States
• Redwood Regional Oncology Center — Santa Rosa, California, United States
• The Oncology Institute of Hope and Innovation — Whittier, California, United States
• Rocky Mountain Cancer Center — Lone Tree, Colorado, United States
• John B. Amos Cancer Center — Columbus, Georgia, United States
• Covenant Clinic — Waterloo, Iowa, United States
• Baptist Health Medical Group — Lexington, Kentucky, United States
• MedStar Health Research Institute — Baltimore, Maryland, United States
• Maryland Oncology Hematology, P.A. — Columbia, Maryland, United States
• Frederick Memorial Hospital — Frederick, Maryland, United States
• Sparrow Health System — Lansing, Michigan, United States
• Hattiesburg Clinic — Hattiesburg, Mississippi, United States
• The Valley Hospital - Luckow Pavilion — Westwood, New Jersey, United States
• Broome Oncology LLC — Johnson City, New York, United States
• Winthrop University Hospital — Mineola, New York, United States
• Clinical Research Alliance, Inc. — New Hyde Park, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Christ Hospital — Cincinnati, Ohio, United States
• University of Toledo Medical Center — Toledo, Ohio, United States
• Charleston Hematology Oncology Associates — Charleston, South Carolina, United States
• Mamie McFaddin Ward Cancer Center — Beaumont, Texas, United States
• Texas Oncology - Dallas Presbyterian Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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