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Non Small Cell Lung CancerPhase 2Cypress 2NCT03382912

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

A Phase 2 study testing Pegilodecakin and Nivolumab in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 35 sites in United States.

Terminated

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

Official record
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Trial 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. 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 Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
35 sitesUnited States
Study dates
22 Mar 2018to 3 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 Wild Type NSCLC that is stage IV / metastatic or recurrent
  • 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
  • Participants with tumor tissue low expression of PD-L1 as defined by Tumor Proportion Score (TPS) 0% - 49%
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 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
  • Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization

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 nivolumab
  • Participants that have received therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
  • Participants with a history of severe hypersensitivity reactions to monoclonal antibodies
Show all 9Show fewer
  • 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
  • Participants receiving any investigational agent within 28 days of first administration of trial treatment
  • Pregnant or lactating women

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • MedStar Health Research Institute

    Baltimore, Maryland, 21237

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29414

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Fairfax Northern Virginia Hematology Oncology, PC

    Fairfax, Virginia, 22031

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • Millennium Oncology

    Houston, Texas, 77090

  • Broome Oncology LLC

    Johnson City, New York, 13790

  • Sparrow Health System

    Lansing, Michigan, 48912

  • Baptist Health Medical Group

    Lexington, Kentucky, 40503

  • Rocky Mountain Cancer Center

    Lone Tree, Colorado, 80124

  • Glendale Adventist Medical Center

    Los Angeles, California, 90017

  • Joe Arrington Cancer Center

    Lubbock, Texas, 79410

  • Texas Oncology - Midland Allison Cancer Center

    Midland, Texas, 79701

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Clinical Research Alliance, Inc.

    New Hyde Park, New York, 11042

  • Oncology and Hematology Associates of Southwest Virginia Inc

    Roanoke, Virginia, 24014

  • Redwood Regional Oncology Center

    Santa Rosa, California, 95403

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • MultiCare Regional Cancer Center - Auburn

    Tacoma, Washington, 98002

  • Arizona Oncology Associates, P.C.

    Tempe, Arizona, 85284

  • US Oncology

    The Woodlands, Texas, 77380

  • University of Toledo Medical Center

    Toledo, Ohio, 43614-2598

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Covenant Clinic

    Waterloo, Iowa, 50702

  • The Valley Hospital - Luckow Pavilion

    Westwood, New Jersey, 07675

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90602

Other trials in United States

About this study

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

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.

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 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%).

Being tested
Pegilodecakin, Nivolumab
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 Nivolumab

  • NivolumabDrug

    Nivolumab Alone

Study groups in NCT03382912
Study groupRoleWhat they receive
Pegilodecakin+NivolumabExperimentalParticipants received Pegilodecakin subcutaneously 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. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every 2 weeks (Q2W), or 480 mg every 4 weeks (Q4W).
Receives: Biological: Pegilodecakin; Drug: Nivolumab
NivolumabActive comparatorParticipants received Nivolumab on day 1 of each 14- or 28- day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every two weeks (Q2W), or 480 mg every 4 weeks (Q4W).
Receives: Drug: Nivolumab

What is being measured

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

  1. Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

    Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.

    Measured: From Date of Randomization to Progressive Disease, Death from Any cause (Up to 6 months after the last participant randomized)

Secondary outcomes (4)

  1. Overall Survival (OS)

    OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was 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 6 months after the last participant randomized)

  2. Progression Free Survival (PFS)

    PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.

    Measured: From Date of Randomization to Progressive Disease or Death Due to Any Cause (Up to 6 months after the last participant randomized)

  3. Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

    Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

    Measured: From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months after the last participant randomization)

  4. Duration of Response

    Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.

    Measured: From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)

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 start22 Mar 2018
  3. Primary completion28 Aug 2019
  4. Study completion3 Mar 2020

Why it stopped: The CYPRESS-2 trial was closed early after the planned final 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
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03382912
Sponsor's protocol ID
17161
Other IDs
J1L-AM-JZGD, AM0010-202
Acronym
Cypress 2
Status last verified
Jun 2020
First submitted
18 Dec 2017
Last updated
11 Sep 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

  • Albrethsen M, Creeden J, Morand S, DeBiase J, Berry B, Stanbery L, Edelman G, Nemunaitis J. Relationship of hypothyroidism and immune response to pegylated IL-10/nivolumab. Immunotherapy. 2020 Oct;12(14):1041-1046. doi: 10.2217/imt-2020-0016. Epub 2020 Aug 18.

    PubMed 32808556

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegilodecakin and Nivolumab in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 35 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 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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 11 Sep 2020). 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 With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] (time frame: From Date of Randomization to Progressive Disease, Death from Any cause (Up to 6 months after the last participant randomized)). 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 NCT03382912, which also lists 2 linked publications.

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 11 Sep 2020.

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