Clinical Trials /

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

NCT03382912

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
  • Official Title: A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1

Clinical Trial IDs

  • ORG STUDY ID: 17161
  • SECONDARY ID: J1L-AM-JZGD
  • SECONDARY ID: AM0010-202
  • NCT ID: NCT03382912

Conditions

  • Non Small Cell Lung Cancer

Interventions

DrugSynonymsArms
PegilodecakinLY3500518, AM00101
Nivolumab1

Purpose

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 stage IV / metastatic wild type non-small cell lung cancer and tumors with
      low tumor expression of PD-L1 (0-49%).
    

Trial Arms

NameTypeDescriptionInterventions
1ExperimentalPegilodecakin self-administered as a SQ injection QD (≤ 80kg body weight = 0.8mg or [0.2mL] > 80kg body weight = 1.6mg [0.4mL]). Nivolumab will be administered as intravenous (IV) infusion on Day 1 of a 14-day cycle (240mg over 30 minutes (± 10min))
  • Pegilodecakin
  • Nivolumab
2Active ComparatorNivolumab will be administered as an intravenous (IV) infusion on Day 1 of a 14-day cycle (240mg over 30 minutes (± 10min))
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          1. Participants must have histologically or cytologically confirmed WT 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate
Time Frame:36 months after the last participant randomized
Safety Issue:
Description:The primary endpoint of this study is ORR defined as the proportion of participants who achieve a CR or PR as assessed by RECIST v.1.1.

Secondary Outcome Measures

Measure:Overall Survival
Time Frame:36 months after the last participant randomized
Safety Issue:
Description:OS defined as the time from date of randomization to death due to any cause
Measure:Progression Free Survival
Time Frame:36 months after the last participant randomized
Safety Issue:
Description:PFS defined as the time from date of randomization to the earlier of first documentation of disease progression or death due to any cause

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Eli Lilly and Company

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