A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 640
- 试验地点
- 133
- 主要终点
- Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
研究概览
简要总结
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).
详细描述
Approximately 600 patients with locally advanced, unresectable ESCC (AJCC 8th cStage II-IVA) will be randomized in a 2:1 ratio to receive either durvalumab + dCRT or placebo + dCRT. The primary objectives of this study are to assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of progression free survival (PFS, per RECIST 1.1 as assessed by BICR) in PD-L1 High population.
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
Sponsor, excluding supply chain management personnel, will remain 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
- •18 years or older at the time of signing the ICF.
- •Histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (Stage II-IVA).
- •Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy.
- •Patients with at least an evaluable lesion per RECIST 1.
- •Mandatory provision of available tumor tissue for PD-L1 expression analysis.
- •ECOG PS 0 or
- •Adequate organ and marrow function.
- •Life expectancy of more than 3 months.
排除标准
- •Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma.
- •Prior anti-cancer treatment for ESCC.
- •Patient with a great risk of perforation and massive bleeding.
- •History of allogeneic organ transplantation.
- •Active or prior documented autoimmune or inflammatory disorders.
- •Uncontrolled intercurrent illness.
- •History of another primary malignancy.
- •Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
- •Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
研究组 & 干预措施
Arm 1: Durvalumab + definitive CRT
Durvalumab + concurrent chemoradiation
干预措施: Durvalumab (Drug)
Arm 2: Placebo + definitive CRT
Placebo + concurrent chemoradiation
干预措施: cisplatin + fluorouracil (Drug)
Arm 2: Placebo + definitive CRT
Placebo + concurrent chemoradiation
干预措施: Radiation (Radiation)
Arm 1: Durvalumab + definitive CRT
Durvalumab + concurrent chemoradiation
干预措施: Radiation (Radiation)
Arm 2: Placebo + definitive CRT
Placebo + concurrent chemoradiation
干预措施: Placebo (Drug)
Arm 2: Placebo + definitive CRT
Placebo + concurrent chemoradiation
干预措施: cisplatin + capecitabine (Drug)
Arm 1: Durvalumab + definitive CRT
Durvalumab + concurrent chemoradiation
干预措施: cisplatin + fluorouracil (Drug)
Arm 1: Durvalumab + definitive CRT
Durvalumab + concurrent chemoradiation
干预措施: cisplatin + capecitabine (Drug)
结局指标
主要结局
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
时间窗: up to approximately 56 months
To assess the efficacy in terms of PFS in PD-L1 High population
次要结局
- Progression free survival (PFS) per RECIST 1.1 as assessed by BICR(up to approximately 56 months)
- Overall survival (OS)(up to approximately 72 months)