The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
233
Pembrolizumab administered intravenously every 3 weeks.
Epacadostat administered orally twice daily.
Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.
Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).
Time frame: Assessed every 12 weeks up to 24 months
Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to 24 months
Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Defined as the time from randomization to death due to any cause.
Time frame: Up to 24 months
Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
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 24 months
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant 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 25 months
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Matching placebo administered orally twice daily.
Southern Cancer Center, PC
Daphne, Alabama, United States
Western Regional Medical Center, Inc.
Goodyear, Arizona, United States
Arizona Oncology Associates PC- HOPE
Tucson, Arizona, United States
Lynn Cancer Institute
Boca Raton, Florida, United States
Florida Cancer Specialists (South Region)
Fort Myers, Florida, United States
Florida Cancer Specialists (North Region)
St. Petersburg, Florida, United States
PPG-Oncology
Fort Wayne, Indiana, United States
University of Michigan
Ann Arbor, Michigan, United States
MMCORC
Saint Louis Park, Minnesota, United States
St. Vincent Healthcare Frontier Cancer Center
Billings, Montana, United States
...and 84 more locations
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of any study drug, whether or not considered related to the study drug.
Time frame: Up to 25 months