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

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ClinicalTrials.gov Identifier: NCT03382899
Recruitment Status : Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
ARMO BioSciences
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Biological: Pegilodecakin Drug: Pembrolizumab Phase 2

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%).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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%)
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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))
Biological: Pegilodecakin
Pegilodecakin plus Pembrolizumab
Other Names:
  • LY3500518
  • AM0010

Drug: Pembrolizumab
Pembrolizumab Alone

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))
Drug: Pembrolizumab
Pembrolizumab Alone




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382899


  Show 74 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
ARMO BioSciences
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03382899     History of Changes
Other Study ID Numbers: 17160
J1L-AM-JZGC ( Other Identifier: Eli Lilly and Company )
AM0010-201 ( Other Identifier: ARMO BioSciences )
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents