Overview

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

Status:
Terminated
Trial end date:
2020-03-03
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Collaborator:
ARMO BioSciences
Treatments:
Nivolumab
Criteria
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