Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    cypress-1
Previous Study | Return to List | Next Study

Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (Cypress 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03382899
Recruitment Status : Terminated (The CYPRESS-1 trial was closed early after the planned final analysis because the risk benefit ratio is unfavorable.)
First Posted : December 26, 2017
Last Update Posted : May 6, 2020
Sponsor:
Collaborator:
ARMO BioSciences
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 18, 2017
First Posted Date  ICMJE December 26, 2017
Last Update Posted Date May 6, 2020
Actual Study Start Date  ICMJE March 19, 2018
Actual Primary Completion Date December 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
Objective Response Rate [ Time Frame: 36 months after the last participant randomized ]
The primary endpoint of this study is ORR defined as the proportion of participants who achieve a CR or PR as assessed by RECIST v.1.1.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
Objective Response Rate [ Time Frame: 36 months after the last patient randomized ]
The primary endpoint of this study is ORR defined as the proportion of patients who achieve a CR or PR as assessed by RECIST v.1.1.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Overall Survival [ Time Frame: 36 months after the last participant randomized ]
    OS defined as the time from date of randomization to death due to any cause
  • Progression Free Survival [ Time Frame: 36 months after the last participant randomized ]
    PFS defined as the time from date of randomization to the earlier of first documentation of disease progression or death due to any cause
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
  • Overall Survival [ Time Frame: 36 months after the last patient randomized ]
    OS defined as the time from date of randomization to death due to any cause
  • Progression Free Survival [ Time Frame: 36 months after the last patient randomized ]
    PFS defined as the time from date of randomization to the earlier of first documentation of disease progression or death due to any cause
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
Official Title  ICMJE 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%)
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%).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE
  • Biological: Pegilodecakin
    Pegilodecakin plus Pembrolizumab
    Other Names:
    • LY3500518
    • AM0010
  • Drug: Pembrolizumab
    Pembrolizumab Alone
Study Arms  ICMJE
  • Experimental: 1
    Pegilodecakin self-administered as a SQ injection QD (≤ 80kg body weight = 0.8mg or [0.2mL] > 80kg body weight = 1.6mg [0.4mL]). Pembrolizumab will be administered as intravenous (IV) infusion on Day 1 of a 21-day cycle (200mg over 30 minutes (± 10min))
    Interventions:
    • Biological: Pegilodecakin
    • Drug: Pembrolizumab
  • Active Comparator: 2
    Pembrolizumab will be administered as an intravenous (IV) infusion on Day 1 of a 21-day cycle (200mg over 30 minutes (± 10min))
    Intervention: Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 4, 2020)
99
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2017)
100
Actual Study Completion Date  ICMJE March 4, 2020
Actual Primary Completion Date December 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03382899
Other Study ID Numbers  ICMJE 17160
J1L-AM-JZGC ( Other Identifier: Eli Lilly and Company )
AM0010-201 ( Other Identifier: ARMO BioSciences )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and 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.
URL: http://www.clinicalstudydatarequest.com
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE ARMO BioSciences
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP