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Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (Cypress 2)

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ClinicalTrials.gov Identifier: NCT03382912
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
ARMO BioSciences
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
To compare the efficacy of pegilodecakin in combination with nivolumab versus nivolumab 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: Nivolumab 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 nivolumab versus nivolumab alone in participants with stage IV / metastatic wild type non-small cell lung cancer and tumors with low tumor expression of PD-L1 (0-49%).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : August 28, 2019
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Arms and Interventions
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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]). Nivolumab will be administered as intravenous (IV) infusion on Day 1 of a 14-day cycle (240mg over 30 minutes (± 10min))
 Biological: Pegilodecakin
Pegilodecakin plus Nivolumab
Other Names:
  • LY3500518
  • AM0010

Drug: Nivolumab
Nivolumab Alone
Active Comparator: 2
Nivolumab will be administered as an intravenous (IV) infusion on Day 1 of a 14-day cycle (240mg over 30 minutes (± 10min))
 Drug: Nivolumab
Nivolumab Alone


Outcome Measures
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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


Eligibility Criteria
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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 must have received at least one prior systemic therapy that was not an anti-PD-1, anti-PD-L1 and/or anti-CTLA-4 treatment for the advanced stage of the disease
  3. Participants with tumor tissue low expression of PD-L1 as defined by Tumor Proportion Score (TPS) 0% - 49%
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  5. Participants with measurable disease by spiral computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumor (RECIST) v.1.1 criteria
  6. Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization

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 nivolumab
  5. Participants that have received therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
  6. Participants with a history of severe hypersensitivity reactions to monoclonal antibodies
  7. 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
  8. Participants receiving any investigational agent within 28 days of first administration of trial treatment
  9. Pregnant or lactating women
Contacts and Locations
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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): NCT03382912


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

  Show 34 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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03382912     History of Changes
Other Study ID Numbers: 17161
J1L-AM-JZGD ( Other Identifier: Eli Lilly and Company )
AM0010-202 ( Other Identifier: ARMO BioSciences )
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Yes

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
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents