Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (Cypress 1)

Lilly

Status and phase: Terminated; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Biological: Pegilodecakin; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03382899

17160

J1L-AM-JZGC (Other Identifier)

AM0010-201 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is an open-label, multi-center, randomized, Phase 2 study designed to compare the efficacy and safety of pegilodecakin in combination with pembrolizumab versus pembrolizumab alone in participants with stage IV / metastatic wild type non-small cell lung cancer and tumors with high expression of PD-L1 (> 50%).

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Pegilodecakin + Pembrolizumab

Experimental group

Description:

Participants received pegilodecakin subcutaneously (SQ) at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (\>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm. Pembrolizumab administered as an intravenous (IV) infusion at 200 mg on Day 1 of a 21-day cycle.

Treatment:

Drug: Pembrolizumab

Biological: Pegilodecakin

Pembrolizumab

Active Comparator group

Description:

Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.

Treatment:

Drug: Pembrolizumab