Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-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 pembrolizumab versus pembrolizumab alone in participants with metastatic non-small cell lung cancer as measured by objective response rate.

Key facts

Study ID

NCT03382899

Run by

Eli Lilly and Company

People needed

101

Starts

2018-03-19

Expected to finish

2020-03-05

Last updated by the study team

2021-01-20

Who can join

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

You may qualify if…

• 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

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 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

Where it is running

• Arizona Oncology Associates, P.C. — Tempe, Arizona, United States
• Beverly Hills Cancer Center — Beverly Hills, California, United States
• St. Joseph Heritage Medical Group — Fullerton, California, United States
• Glendale Adventist Medical Center — Los Angeles, California, United States
• Redlands Community Hospital — Redlands, California, United States
• Redwood Regional Oncology Center — Santa Rosa, California, United States
• The Oncology Institute of Hope and Innovation — Whittier, California, United States
• Memorial Hospital — Colorado Springs, Colorado, United States
• Kaiser Permanente Oncology Clinic — Denver, Colorado, United States
• Rocky Mountain Cancer Center — Lone Tree, Colorado, United States
• Veterans Affairs Connecticut Healthcare System — West Haven, Connecticut, United States
• Medical Oncology Hematolgy Consultants, PA — Newark, Delaware, United States
• Lynn Cancer Institute Ctr for Hem-Onc — Boca Raton, Florida, United States
• Memorial Cancer Institute — Pembroke Pines, Florida, United States
• SCRI- Florida Cancer Specialists — Tallahassee, Florida, United States
• Tallahassee Memorial Cancer Center — Tallahassee, Florida, United States
• Florida Cancer Specialists East — West Palm Beach, Florida, United States
• Northeast Georgia Cancer Care, LLC — Athens, Georgia, United States
• Pacific Diabetes & Endocrine Center — Honolulu, Hawaii, United States
• AMITA Health Cancer Institute & Outpatient Center — Hinsdale, Illinois, United States
• Orchard Healthcare Research Inc — Skokie, Illinois, United States
• Goshen Health System — Goshen, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Covenant Clinic — Waterloo, Iowa, United States
• CCI - Clearview Cancer Institute — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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