A Phase 3, Randomized, Global Trial of Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in First-line Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Phase 3
- Intervention
- Nivolumab
- Conditions
- Lung Cancer
- Sponsor
- Incyte Corporation
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed stage IV or recurrent NSCLC of squamous or non-squamous histology that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
- •No prior treatment with systemic anti-cancer therapy for Stage IV disease.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to
- •Measurable disease by computed tomography or magnetic resonance imaging per RECIST v1.
- •Documentation of program death ligand-1 (PD-L1) status of 0 to 49% by IHC performed by the central laboratory prior to randomization.
- •Other protocol inclusion criteria may apply
Exclusion Criteria
- •Known epidermal growth factor receptor (EGFR) mutations sensitive to available targeted inhibitor therapy.
- •Known ALK or ROS1 rearrangements sensitive to available targeted inhibitor therapy.
- •Untreated central nervous system (CNS) metastases.
- •Unevaluable PD-L1 status or PD-L1 status of ≥ 50% by IHC performed by a central laboratory.
- •Carcinomatous meningitis.
- •Active, known or suspected autoimmune disease.
- •Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, IDO1 targeted agent, or any other antibody or drug targeting T cell co-stimulation or checkpoint pathways.
- •History of allergy or hypersensitivity to platinum-containing compounds or study drug components.
- •Physical and laboratory test findings outside the protocol-defined range.
- •Other protocol exclusion criteria may apply.
Arms & Interventions
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
Intervention: Nivolumab
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
Intervention: Epacadostat
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
Intervention: Carboplatin
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
Intervention: Cisplatin
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
Intervention: Paclitaxel
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
Intervention: Gemcitabine
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
Intervention: Paclitaxel
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
Intervention: Pemetrexed
Arm B
Platinum doublet chemotherapy
Intervention: Carboplatin
Arm B
Platinum doublet chemotherapy
Intervention: Cisplatin
Arm B
Platinum doublet chemotherapy
Intervention: Gemcitabine
Arm B
Platinum doublet chemotherapy
Intervention: Paclitaxel
Arm B
Platinum doublet chemotherapy
Intervention: Pemetrexed
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
Intervention: Nivolumab
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
Intervention: Placebo
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
Intervention: Carboplatin
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
Intervention: Cisplatin
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
Intervention: Gemcitabine
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
Intervention: Pemetrexed
Outcomes
Primary Outcomes
Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Time Frame: Approximately 38 months
Defined as the time from randomization to the date of death from any cause.
Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Time Frame: Approximately 25 months
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.
Secondary Outcomes
- Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)(Approximately 25 months)
- Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)(Approximately 25 months)
- Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)(Approximately 25 months)
- Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)(Approximately 38 months)
- Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)(Approximately 25 months)
- Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)(Approximately 25 months)