A Randomized Phase 2 Trial of AM0010 in Combination With Pembrolizumab vs. Pembrolizumab Alone as First-Line (1L) Therapy in Patients With Stage IV / Metastatic Wild Type (WT) Non-Small Cell Lung Cancer and Tumors With High Expression of PD-L1 (> 50%)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 101
- 试验地点
- 74
- 主要终点
- Percentage of Participants Who Achieved an Objective Response Rate (ORR)
研究概览
简要总结
To compare the efficacy of pegilodecakin in combination with pembrolizumab versus pembrolizumab alone in participants with metastatic non-small cell lung cancer as measured by objective response rate.
详细描述
This is an open-label, multi-center, randomized, Phase 2 study designed to compare the efficacy and safety of pegilodecakin in combination with pembrolizumab versus pembrolizumab alone in participants with stage IV / metastatic wild type non-small cell lung cancer and tumors with high expression of PD-L1 (> 50%).
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
- None
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
- •Participants must have histologically or cytologically confirmed WT NSCLC that is stage IV / metastatic or recurrent
- •Participants with tumor tissue high expression of PD-L1 as defined by Tumor Proportion Score (TPS) ≥ 50%
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Participants with measurable disease by spiral CT or MRI per RECIST v.1.1 criteria.
- •Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization.
- •Participants must be naïve to therapy for the advanced stage of the disease. Previous neoadjuvant or adjuvant therapy is allowed for participants who successfully underwent complete radical surgery and ONLY if the last treatment was administered more than 12 months prior to the start of the trial treatment
排除标准
- •Participants with active central nervous system (CNS) metastases or carcinomatous meningitis
- •Participants with any serious or uncontrolled medical disorder or active infection with the hepatitis virus or the human immunodeficiency virus (HIV)
- •Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue prior to randomization
- •Participants that have received pembrolizumab
- •Participants with a history of severe hypersensitivity reactions to monoclonal antibodies
- •Pregnant or lactating women
- •Participants receiving any investigational agent within 28 days of first administration of trial treatment
- •Participants that have received therapy with anti-tumor vaccines or other immunostimulatory antitumor agents
- •Participants that have received therapy with anti-PD-1, anti-PD-L1, anti-PD-L-2, anti-CD-137, and/or anti CTLA-4 antibodies
研究组 & 干预措施
Pegilodecakin + Pembrolizumab
Participants received pegilodecakin subcutaneously (SQ) at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm.
Pembrolizumab administered as an intravenous (IV) infusion at 200 mg on Day 1 of a 21-day cycle.
干预措施: Pegilodecakin (Biological)
Pegilodecakin + Pembrolizumab
Participants received pegilodecakin subcutaneously (SQ) at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm.
Pembrolizumab administered as an intravenous (IV) infusion at 200 mg on Day 1 of a 21-day cycle.
干预措施: Pembrolizumab (Drug)
Pembrolizumab
Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved an Objective Response Rate (ORR)
时间窗: From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months)
ORR defined as the percentage of participants who achieve a CR or PR as assessed by RECIST v.1.1. The ORR is the number of participants with a complete response (CR) or partial response (PR) divided by the number of randomized participants recorded between the date of randomization and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first. Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters.
次要结局
- Overall Survival (OS)(From Date of Randomization to Death Due to Any Cause (Up to 24 Months))
- Duration of Response (DOR)(From Date of Response to Death Due to Any Cause (Up to 24 Months))
- Progression Free Survival (PFS)(From Date of Randomization to Progressive Disease (PD) or Death Due to Any Cause (Up to 24 Months))
- Percentage of Participants Who Achieved a Disease Control Rate (DCR)(From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 24 Months))