A Phase I Study to Evaluate the Safety and Preliminary Efficacy of [225Ac]Ac-DOTATATE Injection Combined With Tislelizumab in the Maintenance Treatment Period for Patients of Extensive-stage Small Cell Lung Cancer (ES-SCLC) With Somatostatin Receptors (SSTR)+ as First-line Treatment
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- During the dose expansion phase, the efficacy of [225Ac]Ac-DOTATATE injection at the RP2D dose for maintenance treatment in first-line therapy for SSTR-positive ES-SCLC patients when used in combination with tislelizumab was evaluated.
研究概览
简要总结
This is a phase I study to evaluate the safety and preliminary efficacy of [225Ac]Ac-DOTATATE injection combined with tislelizumab in the maintenance treatment period for patients of extensive-stage small cell lung cancer (ES-SCLC) with somatostatin receptors (SSTR)+ as first-line treatment.Patients with ES-SCLC who have completed the induction therapy of first-line standard treatment and are yet to enter the maintenance treatment period are planned to be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have the ability to understand and sign an approved informed consent form (ICF).
- •Patients must be >= 18 and <＝80 years of age.
- •Extensive-stage small cell lung cancer that requires histopathological or cytological confirmation.
- •Presence of at least 1 measurable site of disease (based on RECIST 1.1).
- •ECOG score of 0 or
- •SSTR-PET positive.
- •Sufficient bone marrow capacity and organ function:
- •Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml/min (Cockcroft Gault formula).
- •Hemoglobin≥90g/L, neutrophil count ≥1.5×10^9/L, platelets≥100×10^9/L. Serum total bilirubin ≤1.5×ULN. Serum albumin ≥30g/L. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN，or ALT/AST≤5×ULN with liver metastases.
- •Partially activated prothrombin time (APTT) ≤1.5 x ULN.
- •Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 6 months of the last use of the trial drug.
排除标准
- •Pregnant or lactating females.
- •Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment.
- •Uncontrolled congestive heart failure.
- •uncontrolled diabetes mellitus, including baseline fasting glucose > 2 x ULN.
- •Known hypersensitivity to Lutetium[177Lu] Oxodotreotide Injection or [225Ac]Ac-DOTATATE Injection and their excipients.
- •Other treatment options (e.g., chemotherapy, targeted therapy) that, in the opinion of the investigator, are more appropriate for the patient than the treatment provided in the study based on the patient's disease characteristics.
- •Unsuitable for the study for any reason, in the opinion of the investigator.
研究组 & 干预措施
[225Ac]Ac-DOTATATE
The subjects received the [225Ac]Ac-DOTATATE injection combined with tislelizumab. The tislelizumab was administered at a fixed dose of 200mg on day 1, and was given every 3 weeks. The [225Ac]Ac-DOTATATE injection was administered once every 6 (±1) weeks, with a maximum of 4 administrations.
干预措施: [225Ac]Ac-DOTATATE (Drug)
结局指标
主要结局
During the dose expansion phase, the efficacy of [225Ac]Ac-DOTATATE injection at the RP2D dose for maintenance treatment in first-line therapy for SSTR-positive ES-SCLC patients when used in combination with tislelizumab was evaluated.
时间窗: 12 months after last dose administration
PFS
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection at the RP2D dose for maintenance treatment in first-line therapy for SSTR-positive ES-SCLC patients when used in combination with tislelizumab was evaluated.
时间窗: 6 months after last dose administration
Incidence and severity of adverse events (AEs) DLT MTD RP2D
次要结局
- During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.(12 months after last dose administration)
- During the dose expansion phase, other efficacy endpoint indicators will be evaluated.(12 months after last dose administration)
- During the dose expansion phase, the safety is evaluated.(6 months after last dose administration)