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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT03382912
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pegilodecakin — BIOLOGICAL
    Pegilodecakin plus Nivolumab
  • Nivolumab — DRUG
    Nivolumab Alone

Study Details

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.

Key Dates

Start date
Mar 22, 2018
Status verified
Jun 2020
Primary completion
Aug 28, 2019
Completion
Mar 3, 2020

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pegilodecakin+Nivolumab
    Participants 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).
  • Active Comparator: Nivolumab
    Participants 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).

Primary Outcome 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) ]

Locations (35)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates, P.C.TempeArizona85284-
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
Glendale Adventist Medical CenterLos AngelesCalifornia90017-
Redwood Regional Oncology CenterSanta RosaCalifornia95403-
The Oncology Institute of Hope and InnovationWhittierCalifornia90602-
Rocky Mountain Cancer CenterLone TreeColorado80124-
John B. Amos Cancer CenterColumbusGeorgia31904-
Covenant ClinicWaterlooIowa50702-
Baptist Health Medical GroupLexingtonKentucky40503-
MedStar Health Research InstituteBaltimoreMaryland21237-
Maryland Oncology Hematology, P.A.ColumbiaMaryland21044-
Frederick Memorial HospitalFrederickMaryland21701-
Sparrow Health SystemLansingMichigan48912-
Hattiesburg ClinicHattiesburgMississippi39401-
The Valley Hospital - Luckow PavilionWestwoodNew Jersey07675-
Broome Oncology LLCJohnson CityNew York13790-
Winthrop University HospitalMineolaNew York11501-
Clinical Research Alliance, Inc.New Hyde ParkNew York11042-
Stony Brook University Medical CenterStony BrookNew York11794-
Gabrail Cancer CenterCantonOhio44718-
Christ HospitalCincinnatiOhio45219-
University of Toledo Medical CenterToledoOhio43614-2598-
Charleston Hematology Oncology AssociatesCharlestonSouth Carolina29414-
Mamie McFaddin Ward Cancer CenterBeaumontTexas77702-
Texas Oncology - Dallas Presbyterian HospitalDallasTexas75231-
Texas Oncology-Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
Millennium OncologyHoustonTexas77090-
Texas Oncology-Memorial CityHoustonTexas77024-
Joe Arrington Cancer CenterLubbockTexas79410-
Texas Oncology - Midland Allison Cancer CenterMidlandTexas79701-
US OncologyThe WoodlandsTexas77380-
Texas Oncology - TylerTylerTexas75702-
Fairfax Northern Virginia Hematology Oncology, PCFairfaxVirginia22031-
Oncology and Hematology Associates of Southwest Virginia IncRoanokeVirginia24014-
MultiCare Regional Cancer Center - AuburnTacomaWashington98002-

Find similar trials in Tempe, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Arizona Oncology Associates, P.C.· Tempe, AZBeverly Hills Cancer Center· Beverly Hills, CAGlendale Adventist Medical Center· Los Angeles, CARedwood Regional Oncology Center· Santa Rosa, CAThe Oncology Institute of Hope and Innovation· Whittier, CARocky Mountain Cancer Center· Lone Tree, CO

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