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:

Terminated

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03382912

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, AM0010Pegilodecakin+Nivolumab
NivolumabNivolumab

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
Pegilodecakin+NivolumabExperimentalParticipants received Pegilodecakin subcutaneously 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. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every 2 weeks (Q2W), or 480 mg every 4 weeks (Q4W).
  • Pegilodecakin
  • Nivolumab
NivolumabActive ComparatorParticipants received Nivolumab on day 1 of each 14- or 28- day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every two weeks (Q2W), or 480 mg every 4 weeks (Q4W).
  • Nivolumab

Eligibility 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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Time Frame:From Date of Randomization to Progressive Disease, Death from Any cause (Up to 6 months after the last participant randomized)
Safety Issue:
Description:Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)
Safety Issue:
Description:OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.
Measure:Progression Free Survival (PFS)
Time Frame:From Date of Randomization to Progressive Disease or Death Due to Any Cause (Up to 6 months after the last participant randomized)
Safety Issue:
Description:PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.
Measure:Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Time Frame:From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months after the last participant randomization)
Safety Issue:
Description:Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measure:Duration of Response
Time Frame:From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)
Safety Issue:
Description:Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.

Details

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

Last Updated

September 11, 2020