Back to resultsStudy of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (Cypress 1)
Primary Purpose
Non Small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pegilodecakin
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- CCI - Clearview Cancer Institute
- Arizona Oncology Associates, P.C.
- Beverly Hills Cancer Center
- St. Joseph Heritage Medical Group
- Glendale Adventist Medical Center
- Redlands Community Hospital
- Redwood Regional Oncology Center
- The Oncology Institute of Hope and Innovation
- Memorial Hospital
- Kaiser Permanente Oncology Clinic
- Rocky Mountain Cancer Center
- Veterans Affairs Connecticut Healthcare System
- Medical Oncology Hematolgy Consultants, PA
- Lynn Cancer Institute Ctr for Hem-Onc
- Memorial Cancer Institute
- SCRI- Florida Cancer Specialists
- Tallahassee Memorial Cancer Center
- Florida Cancer Specialists East
- Northeast Georgia Cancer Care, LLC
- Pacific Diabetes & Endocrine Center
- AMITA Health Cancer Institute & Outpatient Center
- Orchard Healthcare Research Inc
- Goshen Health System
- University of Iowa
- Covenant Clinic
- Menorah Medical Center
- Baptist Health Medical Group
- Norton Cancer Institute
- MedStar Research Institute
- Maryland Oncology Hematology, P.A.
- Frederick Memorial Hospital
- St. Joseph Mercy Hospital
- Henry Ford Hospital Detroit
- Sparrow Health System
- Minnesota Oncology/Hematology PA
- University of Minnesota Hospital
- Hattiesburg Clinic
- St John's Mercy Medical Center
- Nebraska Hematology-Oncology
- Morristown Medical Center
- The Valley Hospital - Luckow Pavilion
- Clinical Research Alliance, Inc.
- Winthrop University Hospital
- Stony Brook University Medical Center
- DJL Clinical Research, PLLC
- Southeastern Medical Oncology Center
- Gabrail Cancer Center
- Christ Hospital
- University of Toledo Medical Center
- The Toledo Clinic
- Oncology Associates of Oregon
- Charleston Hematology Oncology Associates
- Avera Cancer Institute
- Chattanooga Oncology Hematology Associates
- Thompson Cancer Survival Center
- Sarah Cannon Research Institute SCRI
- Texas Cancer Center (Abilene)
- Mamie McFaddin Ward Cancer Center
- Texas Oncology - Dallas Presbyterian Hospital
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
- Texas Oncology-Memorial City
- Millennium Oncology
- Joe Arrington Cancer Center
- Texas Oncology - Midland Allison Cancer Center
- Texas Oncology-Sherman
- US Oncology
- Texas Oncology - Tyler
- Texas Oncology-Deke Slayton Cancer Center
- Texas Oncology-Wichital Falls Texoma Cancer Center
- Fairfax Northern Virginia Hematology Oncology, PC
- Oncology and Hematology Associates of Southwest Virginia Inc
- Shenandoah Oncology, P.C.
- MultiCare Regional Cancer Center - Auburn
- The Richland Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pegilodecakin + Pembrolizumab
Pembrolizumab
Arm Description
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.
Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Survival (OS)
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.
Progression Free Survival (PFS)
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)
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.
Duration of Response (DOR)
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.
Full Information
NCT ID
NCT03382899
First Posted
December 18, 2017
Last Updated
January 15, 2021
Sponsor
Eli Lilly and Company
Collaborators
ARMO BioSciences
1. Study Identification
Unique Protocol Identification Number
NCT03382899
Brief Title
Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
Acronym
Cypress 1
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
The CYPRESS-1 trial was closed early after the planned primary analysis because the risk benefit ratio is unfavorable.
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
December 6, 2019 (Actual)
Study Completion Date
March 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
ARMO BioSciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pegilodecakin + Pembrolizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Pembrolizumab
Arm Type
Active Comparator
Arm Description
Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Intervention Type
Biological
Intervention Name(s)
Pegilodecakin
Other Intervention Name(s)
LY3500518, AM0010
Intervention Description
Pegilodecakin plus Pembrolizumab
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab Alone
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved an Objective Response Rate (ORR)
Description
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.
Time Frame
From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
From Date of Randomization to Death Due to Any Cause (Up to 24 Months)
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
From Date of Randomization to Progressive Disease (PD) or Death Due to Any Cause (Up to 24 Months)
Title
Percentage of Participants Who Achieved a Disease Control Rate (DCR)
Description
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.
Time Frame
From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 24 Months)
Title
Duration of Response (DOR)
Description
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.
Time Frame
From Date of Response to Death Due to Any Cause (Up to 24 Months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
CCI - Clearview Cancer Institute
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Arizona Oncology Associates, P.C.
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
St. Joseph Heritage Medical Group
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Glendale Adventist Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Redlands Community Hospital
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Redwood Regional Oncology Center
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Memorial Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Kaiser Permanente Oncology Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Veterans Affairs Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516-2770
Country
United States
Facility Name
Medical Oncology Hematolgy Consultants, PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Lynn Cancer Institute Ctr for Hem-Onc
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Memorial Cancer Institute
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
SCRI- Florida Cancer Specialists
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Tallahassee Memorial Cancer Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Florida Cancer Specialists East
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Northeast Georgia Cancer Care, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Pacific Diabetes & Endocrine Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
AMITA Health Cancer Institute & Outpatient Center
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Orchard Healthcare Research Inc
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Goshen Health System
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Covenant Clinic
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Baptist Health Medical Group
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
MedStar Research Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Maryland Oncology Hematology, P.A.
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Frederick Memorial Hospital
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21701
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Henry Ford Hospital Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Sparrow Health System
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Minnesota Oncology/Hematology PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Minnesota Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
St John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Nebraska Hematology-Oncology
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
The Valley Hospital - Luckow Pavilion
City
Westwood
State/Province
New Jersey
ZIP/Postal Code
07675
Country
United States
Facility Name
Clinical Research Alliance, Inc.
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
DJL Clinical Research, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Southeastern Medical Oncology Center
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614-2598
Country
United States
Facility Name
The Toledo Clinic
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Oncology Associates of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Charleston Hematology Oncology Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Sarah Cannon Research Institute SCRI
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Cancer Center (Abilene)
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Mamie McFaddin Ward Cancer Center
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Texas Oncology - Dallas Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology-Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Millennium Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Joe Arrington Cancer Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Texas Oncology - Midland Allison Cancer Center
City
Midland
State/Province
Texas
ZIP/Postal Code
79701
Country
United States
Facility Name
Texas Oncology-Sherman
City
Sherman
State/Province
Texas
ZIP/Postal Code
75090-0504
Country
United States
Facility Name
US Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Texas Oncology-Deke Slayton Cancer Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598-4219
Country
United States
Facility Name
Texas Oncology-Wichital Falls Texoma Cancer Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Fairfax Northern Virginia Hematology Oncology, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia Inc
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Shenandoah Oncology, P.C.
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
MultiCare Regional Cancer Center - Auburn
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98002
Country
United States
Facility Name
The Richland Hospital
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://www.clinicalstudydatarequest.com
Citations:
PubMed Identifier
33166722
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.
Results Reference
derived
Learn more about this trial
Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
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