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.
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%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Pegilodecakin plus Pembrolizumab
Pembrolizumab Alone
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.
Time frame: From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months)
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.
Time frame: From Date of Randomization to Death Due to Any Cause (Up to 24 Months)
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.
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CCI - Clearview Cancer Institute
Huntsville, Alabama, United States
Arizona Oncology Associates, P.C.
Tempe, Arizona, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
St. Joseph Heritage Medical Group
Fullerton, California, United States
Glendale Adventist Medical Center
Los Angeles, California, United States
Redlands Community Hospital
Redlands, California, United States
Redwood Regional Oncology Center
Santa Rosa, California, United States
The Oncology Institute of Hope and Innovation
Whittier, California, United States
Memorial Hospital
Colorado Springs, Colorado, United States
Kaiser Permanente Oncology Clinic
Denver, Colorado, United States
...and 64 more locations
Time frame: From Date of Randomization to Progressive Disease (PD) or Death Due to Any Cause (Up to 24 Months)
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.
Time frame: From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 24 Months)
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.
Time frame: From Date of Response to Death Due to Any Cause (Up to 24 Months)