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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03382912
Other study ID # 17161
Secondary ID J1L-AM-JZGDAM001
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 22, 2018
Est. completion date March 3, 2020

Study information

Verified date June 2020
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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%).


Recruitment information / eligibility

Status Terminated
Enrollment 52
Est. completion date March 3, 2020
Est. primary completion date August 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Participants must have histologically or cytologically confirmed Wild Type 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

Study Design


Intervention

Biological:
Pegilodecakin
Pegilodecakin plus Nivolumab
Drug:
Nivolumab
Nivolumab Alone

Locations

Country Name City State
United States MedStar Health Research Institute Baltimore Maryland
United States Mamie McFaddin Ward Cancer Center Beaumont Texas
United States Beverly Hills Cancer Center Beverly Hills California
United States Gabrail Cancer Center Canton Ohio
United States Charleston Hematology Oncology Associates Charleston South Carolina
United States Christ Hospital Cincinnati Ohio
United States Maryland Oncology Hematology, P.A. Columbia Maryland
United States John B. Amos Cancer Center Columbus Georgia
United States Texas Oncology - Dallas Presbyterian Hospital Dallas Texas
United States Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas
United States Fairfax Northern Virginia Hematology Oncology, PC Fairfax Virginia
United States Frederick Memorial Hospital Frederick Maryland
United States Hattiesburg Clinic Hattiesburg Mississippi
United States Millennium Oncology Houston Texas
United States Texas Oncology-Memorial City Houston Texas
United States Broome Oncology LLC Johnson City New York
United States Sparrow Health System Lansing Michigan
United States Baptist Health Medical Group Lexington Kentucky
United States Rocky Mountain Cancer Center Lone Tree Colorado
United States Glendale Adventist Medical Center Los Angeles California
United States Joe Arrington Cancer Center Lubbock Texas
United States Texas Oncology - Midland Allison Cancer Center Midland Texas
United States Winthrop University Hospital Mineola New York
United States Clinical Research Alliance, Inc. New Hyde Park New York
United States Oncology and Hematology Associates of Southwest Virginia Inc Roanoke Virginia
United States Redwood Regional Oncology Center Santa Rosa California
United States Stony Brook University Medical Center Stony Brook New York
United States MultiCare Regional Cancer Center - Auburn Tacoma Washington
United States Arizona Oncology Associates, P.C. Tempe Arizona
United States US Oncology The Woodlands Texas
United States University of Toledo Medical Center Toledo Ohio
United States Texas Oncology - Tyler Tyler Texas
United States Covenant Clinic Waterloo Iowa
United States The Valley Hospital - Luckow Pavilion Westwood New Jersey
United States The Oncology Institute of Hope and Innovation Whittier California

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company ARMO BioSciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From Date of Randomization to Progressive Disease, Death from Any cause (Up to 6 months after the last participant randomized)
Secondary 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. From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)
Secondary 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. From Date of Randomization to Progressive Disease or Death Due to Any Cause (Up to 6 months after the last participant randomized)
Secondary 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. From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months after the last participant randomization)
Secondary 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. From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)
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