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

Non Small Cell Lung Cancer Clinical Trial

— Cypress 1  

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%)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03382899
• Other study ID #: 17160
• Secondary ID: J1L-AM-JZGCAM001
• Status: Terminated
• Phase: Phase 2
• Start date: March 19, 2018
• Est. completion date: March 5, 2020

Study information

• Verified date: July 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 pembrolizumab versus pembrolizumab 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 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%).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: March 5, 2020
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participants must have histologically or cytologically confirmed WT NSCLC that is stage IV / metastatic or recurrent

2. Participants with tumor tissue high expression of PD-L1 as defined by Tumor Proportion Score (TPS) = 50%

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

4. Participants with measurable disease by spiral CT or MRI per RECIST v.1.1 criteria.

5. Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization.

6. 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

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 pembrolizumab

5. Participants with a history of severe hypersensitivity reactions to monoclonal antibodies

6. Pregnant or lactating women

7. Participants receiving any investigational agent within 28 days of first administration of trial treatment

8. Participants that have received therapy with anti-tumor vaccines or other immunostimulatory antitumor agents

9. 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

Related Conditions & MeSH terms

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

Intervention

Biological:
• Pegilodecakin
Pegilodecakin plus Pembrolizumab

Drug:
• Pembrolizumab
Pembrolizumab Alone

Locations

Country	Name	City	State
United States	Texas Cancer Center (Abilene)	Abilene	Texas
United States	St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Northeast Georgia Cancer Care, LLC	Athens	Georgia
United States	MedStar Research Institute	Baltimore	Maryland
United States	Mamie McFaddin Ward Cancer Center	Beaumont	Texas
United States	Beverly Hills Cancer Center	Beverly Hills	California
United States	Lynn Cancer Institute Ctr for Hem-Onc	Boca Raton	Florida
United States	Gabrail Cancer Center	Canton	Ohio
United States	Charleston Hematology Oncology Associates	Charleston	South Carolina
United States	DJL Clinical Research, PLLC	Charlotte	North Carolina
United States	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee
United States	Christ Hospital	Cincinnati	Ohio
United States	Memorial Hospital	Colorado Springs	Colorado
United States	Maryland Oncology Hematology, P.A.	Columbia	Maryland
United States	Texas Oncology - Dallas Presbyterian Hospital	Dallas	Texas
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Kaiser Permanente Oncology Clinic	Denver	Colorado
United States	Henry Ford Hospital Detroit	Detroit	Michigan
United States	Oncology Associates of Oregon	Eugene	Oregon
United States	Fairfax Northern Virginia Hematology Oncology, PC	Fairfax	Virginia
United States	Frederick Memorial Hospital	Frederick	Maryland
United States	St. Joseph Heritage Medical Group	Fullerton	California
United States	Goshen Health System	Goshen	Indiana
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	AMITA Health Cancer Institute & Outpatient Center	Hinsdale	Illinois
United States	Pacific Diabetes & Endocrine Center	Honolulu	Hawaii
United States	Millennium Oncology	Houston	Texas
United States	Texas Oncology-Memorial City	Houston	Texas
United States	CCI - Clearview Cancer Institute	Huntsville	Alabama
United States	University of Iowa	Iowa City	Iowa
United States	Southeastern Medical Oncology Center	Jacksonville	North Carolina
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Clinical Research Alliance, Inc.	Lake Success	New York
United States	Sparrow Health System	Lansing	Michigan
United States	Baptist Health Medical Group	Lexington	Kentucky
United States	Nebraska Hematology-Oncology	Lincoln	Nebraska
United States	Rocky Mountain Cancer Center	Lone Tree	Colorado
United States	Glendale Adventist Medical Center	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
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	Minnesota Oncology/Hematology PA	Minneapolis	Minnesota
United States	University of Minnesota Hospital	Minneapolis	Minnesota
United States	Morristown Medical Center	Morristown	New Jersey
United States	Sarah Cannon Research Institute SCRI	Nashville	Tennessee
United States	Medical Oncology Hematolgy Consultants, PA	Newark	Delaware
United States	Menorah Medical Center	Overland Park	Kansas
United States	Memorial Cancer Institute	Pembroke Pines	Florida
United States	Redlands Community Hospital	Redlands	California
United States	Oncology and Hematology Associates of Southwest Virginia Inc	Roanoke	Virginia
United States	St John's Mercy Medical Center	Saint Louis	Missouri
United States	Redwood Regional Oncology Center	Santa Rosa	California
United States	Texas Oncology-Sherman	Sherman	Texas
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Orchard Healthcare Research Inc	Skokie	Illinois
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	MultiCare Regional Cancer Center - Auburn	Tacoma	Washington
United States	SCRI- Florida Cancer Specialists	Tallahassee	Florida
United States	Tallahassee Memorial Cancer Center	Tallahassee	Florida
United States	Arizona Oncology Associates, P.C.	Tempe	Arizona
United States	US Oncology	The Woodlands	Texas
United States	The Toledo Clinic	Toledo	Ohio
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 Richland Hospital	Waukesha	Wisconsin
United States	Texas Oncology-Deke Slayton Cancer Center	Webster	Texas
United States	Veterans Affairs Connecticut Healthcare System	West Haven	Connecticut
United States	Florida Cancer Specialists East	West Palm Beach	Florida
United States	The Valley Hospital - Luckow Pavilion	Westwood	New Jersey
United States	The Oncology Institute of Hope and Innovation	Whittier	California
United States	Texas Oncology-Wichital Falls Texoma Cancer Center	Wichita Falls	Texas
United States	Shenandoah Oncology, P.C.	Winchester	Virginia

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 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.	From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months)
Secondary	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.	From Date of Randomization to Death Due to Any Cause (Up to 24 Months)
Secondary	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.	From Date of Randomization to Progressive Disease (PD) or Death Due to Any Cause (Up to 24 Months)
Secondary	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.	From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 24 Months)
Secondary	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.	From Date of Response to Death Due to Any Cause (Up to 24 Months)