Clinical trial NCT03382899: Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
Official title: A Randomized Phase 2 Trial of AM0010 in Combination With Pembrolizumab vs. Pembrolizumab Alone as First-Line (1L) Therapy in Patients With Stage IV / Metastatic Wild Type (WT) Non-Small Cell Lung Cancer and Tumors With High Expression of PD-L1 (> 50%)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ARMO BioSciences
First posted: 2017-12-26
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%).

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Achieved an Objective Response Rate (ORR)
timeFrame: From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From Date of Randomization to Death Due to Any Cause (Up to 24 Months)
measure: Progression Free Survival (PFS)
timeFrame: From Date of Randomization to Progressive Disease (PD) or Death Due to Any Cause (Up to 24 Months)
measure: Percentage of Participants Who Achieved a Disease Control Rate (DCR)
timeFrame: From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 24 Months)
measure: Duration of Response (DOR)
timeFrame: From Date of Response to Death Due to Any Cause (Up to 24 Months)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: CCI - Clearview Cancer Institute
state: Alabama
city: Tempe
country: United States
facility: Arizona Oncology Associates, P.C.
state: Arizona
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Medical Group
state: California
city: Los Angeles
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Redlands
country: United States
facility: Redlands Community Hospital
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Oncology Center
state: California
city: Whittier
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Colorado Springs
country: United States
facility: Memorial Hospital
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente Oncology Clinic
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: West Haven
country: United States
facility: Veterans Affairs Connecticut Healthcare System
state: Connecticut
city: Newark
country: United States
facility: Medical Oncology Hematolgy Consultants, PA
state: Delaware
city: Boca Raton
country: United States
facility: Lynn Cancer Institute Ctr for Hem-Onc
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute
state: Florida
city: Tallahassee
country: United States
facility: SCRI- Florida Cancer Specialists
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Cancer Center
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists East
state: Florida
city: Athens
country: United States
facility: Northeast Georgia Cancer Care, LLC
state: Georgia
city: Honolulu
country: United States
facility: Pacific Diabetes & Endocrine Center
state: Hawaii
city: Hinsdale
country: United States
facility: AMITA Health Cancer Institute & Outpatient Center
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc
state: Illinois
city: Goshen
country: United States
facility: Goshen Health System
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Waterloo
country: United States
facility: Covenant Clinic
state: Iowa
city: Overland Park
country: United States
facility: Menorah Medical Center
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Medical Group
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Baltimore
country: United States
facility: MedStar Research Institute
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Frederick
country: United States
facility: Frederick Memorial Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital Detroit
state: Michigan
city: Lansing
country: United States
facility: Sparrow Health System
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology/Hematology PA
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Hospital
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Saint Louis
country: United States
facility: St John's Mercy Medical Center
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Hematology-Oncology
state: Nebraska
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Westwood
country: United States
facility: The Valley Hospital - Luckow Pavilion
state: New Jersey
city: Lake Success
country: United States
facility: Clinical Research Alliance, Inc.
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Jacksonville
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Toledo
country: United States
facility: The Toledo Clinic
state: Ohio
city: Eugene
country: United States
facility: Oncology Associates of Oregon
state: Oregon
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute SCRI
state: Tennessee
city: Abilene
country: United States
facility: Texas Cancer Center (Abilene)
state: Texas
city: Beaumont
country: United States
facility: Mamie McFaddin Ward Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: Texas Oncology-Memorial City
state: Texas
city: Houston
country: United States
facility: Millennium Oncology
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Center
state: Texas
city: Midland
country: United States
facility: Texas Oncology - Midland Allison Cancer Center
state: Texas
city: Sherman
country: United States
facility: Texas Oncology-Sherman
state: Texas
city: The Woodlands
country: United States
facility: US Oncology
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Webster
country: United States
facility: Texas Oncology-Deke Slayton Cancer Center
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology-Wichital Falls Texoma Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Fairfax Northern Virginia Hematology Oncology, PC
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia Inc
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology, P.C.
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Regional Cancer Center - Auburn
state: Washington
city: Waukesha
country: United States
facility: The Richland Hospital
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Spigel D, Jotte R, Nemunaitis J, Shum M, Schneider J, Goldschmidt J, Eisenstein J, Berz D, Seneviratne L, Socoteanu M, Bhanderi V, Konduri K, Xia M, Wang H, Hozak RR, Gueorguieva I, Ferry D, Gandhi L, Chao BH, Rybkin I. Randomized Phase 2 Studies of Checkpoint Inhibitors Alone or in Combination With Pegilodecakin in Patients With Metastatic NSCLC (CYPRESS 1 and CYPRESS 2). J Thorac Oncol. 2021 Feb;16(2):327-333. doi: 10.1016/j.jtho.2020.10.001. Epub 2020 Nov 6.