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Non Small Cell Lung CancerPhase 2Cypress 1NCT03382899

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

A Phase 2 study testing Pegilodecakin and Pembrolizumab in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 74 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Pegilodecakin and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
74 sitesUnited States
Study dates
19 Mar 2018to 5 Mar 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

74 sites in 1 country.

74 sites in 1 country

United States74 sites

  • Texas Cancer Center (Abilene)

    Abilene, Texas, 79606

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • MedStar Research Institute

    Baltimore, Maryland, 21237

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Lynn Cancer Institute Ctr for Hem-Onc

    Boca Raton, Florida, 33486

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29414

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28207

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • Memorial Hospital

    Colorado Springs, Colorado, 80909

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Kaiser Permanente Oncology Clinic

    Denver, Colorado, 80205

  • Henry Ford Hospital Detroit

    Detroit, Michigan, 48202

  • Oncology Associates of Oregon

    Eugene, Oregon, 97401

  • Fairfax Northern Virginia Hematology Oncology, PC

    Fairfax, Virginia, 22031

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • St. Joseph Heritage Medical Group

    Fullerton, California, 92835

  • Goshen Health System

    Goshen, Indiana, 46526

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • AMITA Health Cancer Institute & Outpatient Center

    Hinsdale, Illinois, 60521

  • Pacific Diabetes & Endocrine Center

    Honolulu, Hawaii, 96813

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • Millennium Oncology

    Houston, Texas, 77090

  • CCI - Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • University of Iowa

    Iowa City, Iowa, 52242-1009

  • Southeastern Medical Oncology Center

    Jacksonville, North Carolina, 28546

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Clinical Research Alliance, Inc.

    Lake Success, New York, 11042

  • Sparrow Health System

    Lansing, Michigan, 48912

  • Baptist Health Medical Group

    Lexington, Kentucky, 40503

  • Nebraska Hematology-Oncology

    Lincoln, Nebraska, 68506

  • Rocky Mountain Cancer Center

    Lone Tree, Colorado, 80124

  • Glendale Adventist Medical Center

    Los Angeles, California, 90017

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Joe Arrington Cancer Center

    Lubbock, Texas, 79410

  • Texas Oncology - Midland Allison Cancer Center

    Midland, Texas, 79701

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Minnesota Oncology/Hematology PA

    Minneapolis, Minnesota, 55404

  • University of Minnesota Hospital

    Minneapolis, Minnesota, 55455

  • Morristown Medical Center

    Morristown, New Jersey, 07962

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203

  • Medical Oncology Hematolgy Consultants, PA

    Newark, Delaware, 19713

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Memorial Cancer Institute

    Pembroke Pines, Florida, 33028

  • Redlands Community Hospital

    Redlands, California, 92373

  • Oncology and Hematology Associates of Southwest Virginia Inc

    Roanoke, Virginia, 24014

  • Redwood Regional Oncology Center

    Santa Rosa, California, 95403

  • Texas Oncology-Sherman

    Sherman, Texas, 75090-0504

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Orchard Healthcare Research Inc

    Skokie, Illinois, 60077

  • St John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • MultiCare Regional Cancer Center - Auburn

    Tacoma, Washington, 98002

  • SCRI- Florida Cancer Specialists

    Tallahassee, Florida, 32308

  • Tallahassee Memorial Cancer Center

    Tallahassee, Florida, 32308

  • Arizona Oncology Associates, P.C.

    Tempe, Arizona, 85284

  • US Oncology

    The Woodlands, Texas, 77380

  • University of Toledo Medical Center

    Toledo, Ohio, 43614-2598

  • The Toledo Clinic

    Toledo, Ohio, 43623

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Covenant Clinic

    Waterloo, Iowa, 50702

  • The Richland Hospital

    Waukesha, Wisconsin, 53188

  • Texas Oncology-Deke Slayton Cancer Center

    Webster, Texas, 77598-4219

  • Veterans Affairs Connecticut Healthcare System

    West Haven, Connecticut, 06516-2770

  • Florida Cancer Specialists East

    West Palm Beach, Florida, 33401

  • The Valley Hospital - Luckow Pavilion

    Westwood, New Jersey, 07675

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90602

  • Texas Oncology-Wichital Falls Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Shenandoah Oncology, P.C.

    Winchester, Virginia, 22601

Other trials in United States

About this study

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%)

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.

Read the 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%).

Being tested
Pegilodecakin, Pembrolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PegilodecakinBiological

    Also called LY3500518, AM0010

    Pegilodecakin plus Pembrolizumab

  • PembrolizumabDrug

    Pembrolizumab Alone

Study groups in NCT03382899
Study groupRoleWhat they receive
Pegilodecakin + PembrolizumabExperimentalParticipants 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.
Receives: Biological: Pegilodecakin; Drug: Pembrolizumab
PembrolizumabActive comparatorParticipants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months)

Secondary outcomes (4)

  1. 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.

    Measured: From Date of Randomization to Death Due to Any Cause (Up to 24 Months)

  2. 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.

    Measured: From Date of Randomization to Progressive Disease (PD) or Death Due to Any Cause (Up to 24 Months)

  3. 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.

    Measured: From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 24 Months)

  4. 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.

    Measured: From Date of Response to Death Due to Any Cause (Up to 24 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2017
  2. Study start19 Mar 2018
  3. Primary completion6 Dec 2019
  4. Study completion5 Mar 2020

Why it stopped: The CYPRESS-1 trial was closed early after the planned primary analysis because the risk benefit ratio is unfavorable.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03382899
Sponsor's protocol ID
17160
Other IDs
J1L-AM-JZGC, AM0010-201
Acronym
Cypress 1
Status last verified
Jul 2020
First submitted
18 Dec 2017
Last updated
20 Jan 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 33166722

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegilodecakin and Pembrolizumab in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 74 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved an Objective Response Rate (ORR) (time frame: From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03382899, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.

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