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)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
干预措施: Nivolumab (Drug)
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
干预措施: Epacadostat (Drug)
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
干预措施: Carboplatin (Drug)
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
干预措施: Cisplatin (Drug)
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
干预措施: Paclitaxel (Drug)
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
干预措施: Gemcitabine (Drug)
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
干预措施: Paclitaxel (Drug)
Arm A
Nivolumab plus epacadostat in combination with platinum doublet
干预措施: Pemetrexed (Drug)
Arm B
Platinum doublet chemotherapy
干预措施: Carboplatin (Drug)
Arm B
Platinum doublet chemotherapy
干预措施: Cisplatin (Drug)
Arm B
Platinum doublet chemotherapy
干预措施: Gemcitabine (Drug)
Arm B
Platinum doublet chemotherapy
干预措施: Paclitaxel (Drug)
Arm B
Platinum doublet chemotherapy
干预措施: Pemetrexed (Drug)
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
干预措施: Nivolumab (Drug)
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
干预措施: Placebo (Drug)
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
干预措施: Carboplatin (Drug)
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
干预措施: Cisplatin (Drug)
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
干预措施: Gemcitabine (Drug)
Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
时间窗: 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)
时间窗: 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.
次要结局
- 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)