The purpose of this study was to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
Epacadostat administered orally at the protocol-defined dose twice daily.
Matching placebo for epacadostat administered orally twice daily.
Pacific Cancer Medical Center, Inc
Anaheim, California, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Defined as the time from randomization to the date of death from any cause.
Time frame: Approximately 38 months
Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first.
Time frame: Approximately 25 months
Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by blinded independent central review.
Time frame: Approximately 25 months
Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.
Time frame: Approximately 25 months
Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Defined as the time from randomization to the date of death from any cause.
Time frame: Approximately 38 months
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Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.
Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first.
Time frame: Approximately 25 months
Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review.
Time frame: Approximately 25 months
Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.
Time frame: Approximately 25 months