The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
154
Pembrolizumab administered intravenously every 3 weeks.
Epacadostat administered orally twice daily.
Matching placebo administered orally twice daily.
Objective Response Rate (ORR) of Pembrolizumab Plus Epacadostat Versus Pembrolizumab Plus Placebo
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on blinded independent central review (BICR).
Time frame: Up to approximately 6 months
Progression-free Survival (PFS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 based on BICR or death due to any cause, whichever occurs first.
Time frame: Up to approximately 36 months
Overall Survival (OS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 36 months
Duration of Response (DOR) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
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.
Time frame: Up to approximately 36 months
Number of Participants With Adverse Events (AEs)
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to 37 months
Number of Participants Who Discontinued Study Drug Due to AEs
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Florida Cancer Specialists (South Region)
Fort Myers, Florida, United States
Florida Cancer Specialists (North Region)
St. Petersburg, Florida, United States
Southeastern Regional Medical Center, Inc.
Newnan, Georgia, United States
Anne Arundel Health System Research Institute
Annapolis, Maryland, United States
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Minnesota Oncology Hematology, PA
Coon Rapids, Minnesota, United States
...and 91 more locations
Time frame: Up to 37 months