SHR-1316 Plus Chemotherapy and Sequential Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): a Phase II Trial

Shandong Cancer Hospital and Institute1 个研究点分布在 1 个国家目标入组 67 人开始时间: 2020年10月1日最近更新: 2024年7月3日

适应症

干预措施

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 67
试验地点: 1
主要终点: overall survival （OS）

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the tolerance and preliminary efficacy of SHR1316 combined with chest radiotherapy after induction therapy.

详细描述

This is a single-arm, single-center phase II study. Eligible subjects will receive the following treatment regimens: 4~6 cycles of SHR1316 combined with EP/EC (etoposide, 100mg/m2, D1-3, q3w and cisplatin, 75mg/m², D1, q3w or carboplatin, AUC=5, D1, q3w). Patients with response sequentially received adebrelimab combined with chest radiotherapy based on investigator decision. Patients then the maintenance therapy with adebrelimab until disease progression or intolerable AEs.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Confirmed diagnosis of Extensive small cell lung cancer
•Eastern Cooperative Oncology Group performance status (PS) of 0 to 1
•18 to 75 years old
•The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10^9/L, ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 times ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN
•have not received first-line systemic therapy or immunosuppressive therapy for es-sclc
•The estimated survival period is more than 8 weeks
•With measurable lesion defined by the RECIST v1.1: Previously irradiated lesions may only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease;
•Signed written informed consent prior to study entry

排除标准

•Active or untreated CNS metastases
•Leptomeningeal diseases
•Uncontrolled or symptomatic hypercalcemia
•Active, known or suspected autoimmune diseases
•have received any T cell co stimulation or immune checkpoint therapy
•Corticosteroids (> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug.
•Subjects had active infections.
•Failing to properly control the clinical symptoms or disease of the heart
•Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation
•Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to cisplatin or etoposide
•According to the researcher's judgment, there are other factors that may lead to the termination of the study