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 |
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Recruitment Status :
Terminated
(The CYPRESS-2 trial was closed early after the planned final analysis because the risk benefit ratio is unfavorable.)
First Posted : December 26, 2017
Results First Posted : September 11, 2020
Last Update Posted : September 11, 2020
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Sponsor:
Eli Lilly and Company
Collaborator:
ARMO BioSciences
Information provided by (Responsible Party):
Eli Lilly and Company
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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 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 52 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 |
| Actual Primary Completion Date : | August 28, 2019 |
| Actual Study Completion Date : | March 3, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Nivolumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pegilodecakin+Nivolumab
Participants 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). |
Biological: Pegilodecakin
Pegilodecakin plus Nivolumab
Other Names:
Drug: Nivolumab Nivolumab Alone |
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Active Comparator: Nivolumab
Participants 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).
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Drug: Nivolumab
Nivolumab Alone |
Primary Outcome Measures :
- 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) ]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.
Secondary Outcome Measures :
- Overall Survival (OS) [ Time Frame: From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized) ]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.
- Progression Free Survival (PFS) [ Time Frame: From Date of Randomization to Progressive Disease or Death Due to Any Cause (Up to 6 months after the last participant randomized) ]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.
- Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [ Time Frame: From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months after the last participant randomization) ]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.
- Duration of Response [ Time Frame: From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized) ]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.
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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:
- 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
Exclusion Criteria:
- 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
- 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
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
Locations
Show 35 study locations
Sponsors and Collaborators
Eli Lilly and Company
ARMO BioSciences
Investigators
| 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 |
Study Documents (Full-Text)
Documents provided by Eli Lilly and Company:
Documents provided by Eli Lilly and Company:
Study Protocol [PDF] February 6, 2019
Statistical Analysis Plan [PDF] September 10, 2019
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT03382912 |
| 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 |
| Results First Posted: | September 11, 2020 |
| Last Update Posted: | September 11, 2020 |
| Last Verified: | June 2020 |
| 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 |
| 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 Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |