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

Non Small Cell Lung Cancer Clinical Trial

— Cypress 2  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03382912
• Other study ID #: 17161
• Secondary ID: J1L-AM-JZGDAM001
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

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)