TerminatedPhase 2NCT03382899

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

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.

Checked against the public recordLast updated Jan 20, 2021 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations74
SponsorEli Lilly and Company
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Eli Lilly and Company
Interventions being studied
Biological: Pegilodecakin; Drug: Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed WT NSCLC that is stage IV / metastatic or recurrent 2. Participants with tumor tissue high expression of PD-L1 as defined by Tumor Proportion Score (TPS) ≥ 50% 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Participants with measurable disease by spiral CT or MRI per RECIST v.1.1 criteria. 5. Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization. 6. 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: 1. Participants with active central nervous system (CNS) metastases or carcinomatous meningitis 2. Participants with any serious or uncontrolled medical disorder or active infection with the hepatitis virus or the human immunodeficiency virus (HIV) 3. Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue prior to randomization 4. Participants that have received pembrolizumab 5. Participants with a history of severe hypersensitivity reactions to monoclonal antibodies 6. Pregnant or lactating women 7. Participants receiving any investigational agent within 28 days of first administration of trial treatment 8. Participants that have received therapy with anti-tumor vaccines or other immunostimulatory antitumor agents 9. 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • CCI - Clearview Cancer InstituteHuntsville, Alabama
  • Arizona Oncology Associates, P.C.Tempe, Arizona
  • Beverly Hills Cancer CenterBeverly Hills, California
  • St. Joseph Heritage Medical GroupFullerton, California
  • Glendale Adventist Medical CenterLos Angeles, California
  • Redlands Community HospitalRedlands, California
  • Redwood Regional Oncology CenterSanta Rosa, California
  • The Oncology Institute of Hope and InnovationWhittier, California
  • Memorial HospitalColorado Springs, Colorado
  • Kaiser Permanente Oncology ClinicDenver, Colorado
  • Rocky Mountain Cancer CenterLone Tree, Colorado
  • Veterans Affairs Connecticut Healthcare SystemWest Haven, Connecticut

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 20, 2021. Always confirm current availability with the study team.

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