A Phase 2, Randomized, Double-Blind Study of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Versus Pembrolizumab Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer Expressing High Levels of PD-L1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 99
- 主要终点
- Objective Response Rate (ORR) of Pembrolizumab Plus Epacadostat Versus Pembrolizumab Plus Placebo
研究概览
简要总结
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).
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)
盲法说明
With the implementation of Amendment 05 the study is no longer blinded.
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 or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation.
- •Measurable disease based on RECIST 1.
- •Tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥ 50% of tumor cells (tumor proportion score [TPS] ≥ 50%) as assessed by immunohistochemistry at a central laboratory.
- •Life expectancy of at least 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ function per protocol-defined criteria.
排除标准
- •Known untreated central nervous system metastases and/or carcinomatous meningitis.
- •History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
- •Symptomatic ascites or pleural effusion.
- •Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
- •Active autoimmune disease that has required systemic treatment in past 2 years.
- •Has had an allogeneic tissue/solid organ transplant.
- •Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
- •Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
- •History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
- •Use of protocol-defined prior/concomitant therapy.
研究组 & 干预措施
Pembrolizumab + Placebo
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
干预措施: Pembrolizumab (Drug)
Pembrolizumab + Epacadostat
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
干预措施: Pembrolizumab (Drug)
Pembrolizumab + Epacadostat
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
干预措施: Epacadostat (Drug)
Pembrolizumab + Placebo
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
干预措施: Placebo (Drug)
结局指标
主要结局
Objective Response Rate (ORR) of Pembrolizumab Plus Epacadostat Versus Pembrolizumab Plus Placebo
时间窗: Up to approximately 6 months
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).
次要结局
- Number of Participants With Adverse Events (AEs)(Up to 37 months)
- Progression-free Survival (PFS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo(Up to approximately 36 months)
- Overall Survival (OS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo(Up to approximately 36 months)
- Duration of Response (DOR) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo(Up to approximately 36 months)
- Number of Participants Who Discontinued Study Drug Due to AEs(Up to 37 months)