Status:
TERMINATED
Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
ARMO BioSciences
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
This is an open-label, multi-center, randomized, Phase 2 study designed to compare the efficacy and safety of pegilodecakin in combination with nivolumab versus nivolumab alone in participants with st...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03382912
Start Date
March 22 2018
End Date
March 3 2020
Last Update
September 11 2020
Active Locations (35)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Oncology Associates, P.C.
Tempe, Arizona, United States, 85284
2
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
3
Glendale Adventist Medical Center
Los Angeles, California, United States, 90017
4
Redwood Regional Oncology Center
Santa Rosa, California, United States, 95403