Study Stopped
The CYPRESS-1 trial was closed early after the planned primary analysis because the risk benefit ratio is unfavorable.
Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
Cypress 1
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%)
3 other identifiers
interventional
101
1 country
74
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2018
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2017
CompletedFirst Posted
Study publicly available on registry
December 26, 2017
CompletedStudy Start
First participant enrolled
March 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2020
CompletedResults Posted
Study results publicly available
January 20, 2021
CompletedJanuary 20, 2021
July 1, 2020
1.7 years
December 18, 2017
December 4, 2020
January 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved an Objective Response Rate (ORR)
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.
From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months)
Secondary Outcomes (4)
Overall Survival (OS)
From Date of Randomization to Death Due to Any Cause (Up to 24 Months)
Progression Free Survival (PFS)
From Date of Randomization to Progressive Disease (PD) or Death Due to Any Cause (Up to 24 Months)
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)
Duration of Response (DOR)
From Date of Response to Death Due to Any Cause (Up to 24 Months)
Study Arms (2)
Pegilodecakin + Pembrolizumab
EXPERIMENTALParticipants 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
ACTIVE COMPARATORParticipants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Interventions
Pegilodecakin plus Pembrolizumab
Eligibility Criteria
You may qualify if:
- 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 naĂ¯ve 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- ARMO BioSciencescollaborator
Study Sites (74)
CCI - Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Arizona Oncology Associates, P.C.
Tempe, Arizona, 85284, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
St. Joseph Heritage Medical Group
Fullerton, California, 92835, United States
Glendale Adventist Medical Center
Los Angeles, California, 90017, United States
Redlands Community Hospital
Redlands, California, 92373, United States
Redwood Regional Oncology Center
Santa Rosa, California, 95403, United States
The Oncology Institute of Hope and Innovation
Whittier, California, 90602, United States
Memorial Hospital
Colorado Springs, Colorado, 80909, United States
Kaiser Permanente Oncology Clinic
Denver, Colorado, 80205, United States
Rocky Mountain Cancer Center
Lone Tree, Colorado, 80124, United States
Veterans Affairs Connecticut Healthcare System
West Haven, Connecticut, 06516-2770, United States
Medical Oncology Hematolgy Consultants, PA
Newark, Delaware, 19713, United States
Lynn Cancer Institute Ctr for Hem-Onc
Boca Raton, Florida, 33486, United States
Memorial Cancer Institute
Pembroke Pines, Florida, 33028, United States
SCRI- Florida Cancer Specialists
Tallahassee, Florida, 32308, United States
Tallahassee Memorial Cancer Center
Tallahassee, Florida, 32308, United States
Florida Cancer Specialists East
West Palm Beach, Florida, 33401, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96813, United States
AMITA Health Cancer Institute & Outpatient Center
Hinsdale, Illinois, 60521, United States
Orchard Healthcare Research Inc
Skokie, Illinois, 60077, United States
Goshen Health System
Goshen, Indiana, 46526, United States
University of Iowa
Iowa City, Iowa, 52242-1009, United States
Covenant Clinic
Waterloo, Iowa, 50702, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Baptist Health Medical Group
Lexington, Kentucky, 40503, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
MedStar Research Institute
Baltimore, Maryland, 21237, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Henry Ford Hospital Detroit
Detroit, Michigan, 48202, United States
Sparrow Health System
Lansing, Michigan, 48912, United States
Minnesota Oncology/Hematology PA
Minneapolis, Minnesota, 55404, United States
University of Minnesota Hospital
Minneapolis, Minnesota, 55455, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
St John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Nebraska Hematology-Oncology
Lincoln, Nebraska, 68506, United States
Morristown Medical Center
Morristown, New Jersey, 07962, United States
The Valley Hospital - Luckow Pavilion
Westwood, New Jersey, 07675, United States
Clinical Research Alliance, Inc.
Lake Success, New York, 11042, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28207, United States
Southeastern Medical Oncology Center
Jacksonville, North Carolina, 28546, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Toledo Medical Center
Toledo, Ohio, 43614-2598, United States
The Toledo Clinic
Toledo, Ohio, 43623, United States
Oncology Associates of Oregon
Eugene, Oregon, 97401, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, 29414, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, 37203, United States
Texas Cancer Center (Abilene)
Abilene, Texas, 79606, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology-Memorial City
Houston, Texas, 77024, United States
Millennium Oncology
Houston, Texas, 77090, United States
Joe Arrington Cancer Center
Lubbock, Texas, 79410, United States
Texas Oncology - Midland Allison Cancer Center
Midland, Texas, 79701, United States
Texas Oncology-Sherman
Sherman, Texas, 75090-0504, United States
US Oncology
The Woodlands, Texas, 77380, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Texas Oncology-Deke Slayton Cancer Center
Webster, Texas, 77598-4219, United States
Texas Oncology-Wichital Falls Texoma Cancer Center
Wichita Falls, Texas, 76310, United States
Fairfax Northern Virginia Hematology Oncology, PC
Fairfax, Virginia, 22031, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Roanoke, Virginia, 24014, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, 22601, United States
MultiCare Regional Cancer Center - Auburn
Tacoma, Washington, 98002, United States
The Richland Hospital
Waukesha, Wisconsin, 53188, United States
Related Publications (1)
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.
PMID: 33166722DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated early after completion of primary analysis; hence, no mature data were available for final analysis.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2017
First Posted
December 26, 2017
Study Start
March 19, 2018
Primary Completion
December 6, 2019
Study Completion
March 5, 2020
Last Updated
January 20, 2021
Results First Posted
January 20, 2021
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.