Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Biological: PegilodecakinDrug: Pembrolizumab
- Registration Number
- NCT03382899
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- 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 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%).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 101
- Participants must have histologically or cytologically confirmed WT NSCLC that is stage IV / metastatic or recurrent
- Participants with tumor tissue high expression of PD-L1 as defined by Tumor Proportion Score (TPS) ≥ 50%
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants with measurable disease by spiral CT or MRI per RECIST v.1.1 criteria.
- Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization.
- 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
- Participants with active central nervous system (CNS) metastases or carcinomatous meningitis
- Participants with any serious or uncontrolled medical disorder or active infection with the hepatitis virus or the human immunodeficiency virus (HIV)
- Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue prior to randomization
- Participants that have received pembrolizumab
- Participants with a history of severe hypersensitivity reactions to monoclonal antibodies
- Pregnant or lactating women
- Participants receiving any investigational agent within 28 days of first administration of trial treatment
- Participants that have received therapy with anti-tumor vaccines or other immunostimulatory antitumor agents
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pegilodecakin + Pembrolizumab Pegilodecakin 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. Pegilodecakin + Pembrolizumab Pembrolizumab 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. Pembrolizumab Pembrolizumab Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieved an Objective Response Rate (ORR) From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months) ORR defined as the percentage of participants who achieve a CR or PR as assessed by RECIST v.1.1. The ORR is the number of participants with a complete response (CR) or partial response (PR) divided by the number of randomized participants recorded between the date of randomization and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first. Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From Date of Randomization to Death Due to Any Cause (Up to 24 Months) OS is defined as the time from date of randomization to death due to any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the participant was known to be alive.
Duration of Response (DOR) From Date of Response to Death Due to Any Cause (Up to 24 Months) DOR is defined as the time from the earliest date of qualifying response until earliest date of disease progression per RECIST v1.1 or death from any cause, whichever comes first. Duration of response was analyzed in participants who had CR or PR. Duration of response was censored on the date of the last tumor assessment on trial for participants who did not have objective tumor progression and who did not die due to any cause while on trial. For participants who discontinued participation in the trial or discontinued from tumor scan assessments before disease progression, the duration of response was censored at the date of the last tumor assessment.
Progression Free Survival (PFS) From Date of Randomization to Progressive Disease (PD) or Death Due to Any Cause (Up to 24 Months) PFS is defined as the time from date of randomization to the earlier of first documentation of disease progression or death due to any cause. Progressive disease (PD) is defined by at least a 20% increase in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters or the presence of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression determined by scans. Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow up before documented progression and death or were censored at the date of last adequate tumor assessment, participants or new anticancer therapy started and not tumor progression or death were censored at the last adequate tumor assessment before the start of new anticancer therapy.
Percentage of Participants Who Achieved a Disease Control Rate (DCR) From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 24 Months) DCR is defined as the percentage of participants in the analysis population who have achieved a complete response (CR), partial response (PR) or stable disease (SD) response prior to disease progression. CR is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. PR is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters. SD is defined as neither sufficient shrinkage of target lesions to qualify for partial response, nor sufficient increase to qualify for progressive disease, taking as reference the baseline sum of longest diameters.
Trial Locations
- Locations (74)
Maryland Oncology Hematology, P.A.
🇺🇸Columbia, Maryland, United States
The Oncology Institute of Hope and Innovation
🇺🇸Whittier, California, United States
Orchard Healthcare Research Inc
🇺🇸Skokie, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
St. Joseph Heritage Medical Group
🇺🇸Fullerton, California, United States
Memorial Cancer Institute
🇺🇸Pembroke Pines, Florida, United States
Florida Cancer Specialists East
🇺🇸West Palm Beach, Florida, United States
Goshen Health System
🇺🇸Goshen, Indiana, United States
Lynn Cancer Institute Ctr for Hem-Onc
🇺🇸Boca Raton, Florida, United States
Medical Oncology Hematolgy Consultants, PA
🇺🇸Newark, Delaware, United States
MultiCare Regional Cancer Center - Auburn
🇺🇸Tacoma, Washington, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
The Richland Hospital
🇺🇸Waukesha, Wisconsin, United States
University of Minnesota Hospital
🇺🇸Minneapolis, Minnesota, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Texas Oncology-Memorial City
🇺🇸Houston, Texas, United States
Millennium Oncology
🇺🇸Houston, Texas, United States
Menorah Medical Center
🇺🇸Overland Park, Kansas, United States
Henry Ford Hospital Detroit
🇺🇸Detroit, Michigan, United States
Sarah Cannon Research Institute SCRI
🇺🇸Nashville, Tennessee, United States
Redlands Community Hospital
🇺🇸Redlands, California, United States
Arizona Oncology Associates, P.C.
🇺🇸Tempe, Arizona, United States
CCI - Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Beverly Hills Cancer Center
🇺🇸Beverly Hills, California, United States
Glendale Adventist Medical Center
🇺🇸Los Angeles, California, United States
Memorial Hospital
🇺🇸Colorado Springs, Colorado, United States
Rocky Mountain Cancer Center
🇺🇸Lone Tree, Colorado, United States
Veterans Affairs Connecticut Healthcare System
🇺🇸West Haven, Connecticut, United States
AMITA Health Cancer Institute & Outpatient Center
🇺🇸Hinsdale, Illinois, United States
Northeast Georgia Cancer Care, LLC
🇺🇸Athens, Georgia, United States
SCRI- Florida Cancer Specialists
🇺🇸Tallahassee, Florida, United States
Tallahassee Memorial Cancer Center
🇺🇸Tallahassee, Florida, United States
Covenant Clinic
🇺🇸Waterloo, Iowa, United States
MedStar Research Institute
🇺🇸Baltimore, Maryland, United States
Frederick Memorial Hospital
🇺🇸Frederick, Maryland, United States
Sparrow Health System
🇺🇸Lansing, Michigan, United States
Minnesota Oncology/Hematology PA
🇺🇸Minneapolis, Minnesota, United States
St John's Mercy Medical Center
🇺🇸Saint Louis, Missouri, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Nebraska Hematology-Oncology
🇺🇸Lincoln, Nebraska, United States
The Valley Hospital - Luckow Pavilion
🇺🇸Westwood, New Jersey, United States
Clinical Research Alliance, Inc.
🇺🇸Lake Success, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
DJL Clinical Research, PLLC
🇺🇸Charlotte, North Carolina, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Southeastern Medical Oncology Center
🇺🇸Jacksonville, North Carolina, United States
University of Toledo Medical Center
🇺🇸Toledo, Ohio, United States
The Toledo Clinic
🇺🇸Toledo, Ohio, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Chattanooga Oncology Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
Texas Cancer Center (Abilene)
🇺🇸Abilene, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital
🇺🇸Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology - Midland Allison Cancer Center
🇺🇸Midland, Texas, United States
Joe Arrington Cancer Center
🇺🇸Lubbock, Texas, United States
US Oncology
🇺🇸The Woodlands, Texas, United States
Texas Oncology-Sherman
🇺🇸Sherman, Texas, United States
Texas Oncology - Tyler
🇺🇸Tyler, Texas, United States
Texas Oncology-Deke Slayton Cancer Center
🇺🇸Webster, Texas, United States
Fairfax Northern Virginia Hematology Oncology, PC
🇺🇸Fairfax, Virginia, United States
Texas Oncology-Wichital Falls Texoma Cancer Center
🇺🇸Wichita Falls, Texas, United States
Oncology and Hematology Associates of Southwest Virginia Inc
🇺🇸Roanoke, Virginia, United States
Redwood Regional Oncology Center
🇺🇸Santa Rosa, California, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Kaiser Permanente Oncology Clinic
🇺🇸Denver, Colorado, United States
Charleston Hematology Oncology Associates
🇺🇸Charleston, South Carolina, United States
Baptist Health Medical Group
🇺🇸Lexington, Kentucky, United States
Pacific Diabetes & Endocrine Center
🇺🇸Honolulu, Hawaii, United States
Mamie McFaddin Ward Cancer Center
🇺🇸Beaumont, Texas, United States
Oncology Associates of Oregon
🇺🇸Eugene, Oregon, United States
Shenandoah Oncology, P.C.
🇺🇸Winchester, Virginia, United States