Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated Sep 11, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Eli Lilly and Company
- Interventions being studied
- Biological: Pegilodecakin; Drug: Nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed Wild Type NSCLC that is stage IV / metastatic or recurrent 2. 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 3. Participants with tumor tissue low expression of PD-L1 as defined by Tumor Proportion Score (TPS) 0% - 49% 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. 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 6. Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization 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 nivolumab 5. Participants that have received therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents 6. Participants with a history of severe hypersensitivity reactions to monoclonal antibodies 7. 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 8. Participants receiving any investigational agent within 28 days of first administration of trial treatment 9. Pregnant or lactating women
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Arizona Oncology Associates, P.C.Tempe, Arizona
- Beverly Hills Cancer CenterBeverly Hills, California
- Glendale Adventist Medical CenterLos Angeles, California
- Redwood Regional Oncology CenterSanta Rosa, California
- The Oncology Institute of Hope and InnovationWhittier, California
- Rocky Mountain Cancer CenterLone Tree, Colorado
- John B. Amos Cancer CenterColumbus, Georgia
- Covenant ClinicWaterloo, Iowa
- Baptist Health Medical GroupLexington, Kentucky
- MedStar Health Research InstituteBaltimore, Maryland
- Maryland Oncology Hematology, P.A.Columbia, Maryland
- Frederick Memorial HospitalFrederick, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 11, 2020. Always confirm current availability with the study team.