Clinical Study of Programmed Cell Death Ligand-1(PD-L1) Antibody (Atezolizumab) Plus Chemotherapy (Carboplatin Plus Etoposide) for Previously Untreated Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease free survival（DFS）
研究概览
简要总结
This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy compared with treatment with Chemotherapy alone in previously untreated Limited-Stage Small Cell Lung Cancer patients.
详细描述
This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy (Carboplatin plus Etoposide) compared with treatment with Chemotherapy (Carboplatin plus Etoposide) alone in previously untreated Limited-Stage Small Cell Lung Cancer patients. Participants will be divided in a 1:1 ratio to receive either Atezolizumab + Carboplatin + Etoposide or Carboplatin + Etoposide followed by radical surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be volunteered to participate in the clinical trial. Patients must sign the informed Consent form (ICF) and be willing to follow and able to complete all test procedures.
- •Histologically or cytologically confirmed stage IIb-IIIb SCLC.
- •Patients with good physical condition and good organ function.
- •Previously untreated patients.
- •Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- •Patients can tolerate chemotherapy, immunotherapy, and surgery.
排除标准
- •Unclear diagnosis of SCLC.
- •Contraindicated chemotherapy, immunotherapy, and surgery.
- •Undergoing other active malignancies within 5 years or at the same time.Patients with localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ, will not be excluded.
- •Positive test result for human immunodeficiency virus (HIV).
- •Positive test result for active tuberculosis.
- •Pregnant or lactating women
- •A history of psychotropic substance abuse, drug abuse, or alcoholism.
- •Other factors assessed by the sponsors.
研究组 & 干预措施
Atezolizumab + Carboplatin +Etoposide +surgery
Neoadjuvant therapy: Atezolizumab, 1200 milligrams(mg) on Day 1 of every 21-day cycle, 2 cycles; Carboplatin, 75 mg per square meter(mg/m^2) on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m^2 on Day 1 of every 3-day cycle, 2 cycles.
Surgery: patients will receive surgery.
干预措施: Atezolizumab (Drug)
Atezolizumab + Carboplatin +Etoposide +surgery
Neoadjuvant therapy: Atezolizumab, 1200 milligrams(mg) on Day 1 of every 21-day cycle, 2 cycles; Carboplatin, 75 mg per square meter(mg/m^2) on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m^2 on Day 1 of every 3-day cycle, 2 cycles.
Surgery: patients will receive surgery.
干预措施: Carboplatin (Drug)
Atezolizumab + Carboplatin +Etoposide +surgery
Neoadjuvant therapy: Atezolizumab, 1200 milligrams(mg) on Day 1 of every 21-day cycle, 2 cycles; Carboplatin, 75 mg per square meter(mg/m^2) on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m^2 on Day 1 of every 3-day cycle, 2 cycles.
Surgery: patients will receive surgery.
干预措施: Etoposide (Drug)
Carboplatin +Etoposide +surgery
Neoadjuvant therapy: Carboplatin, 75 mg/m^2 on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m^2 on Day 1 of every 3-day cycle, 2 cycles.
Surgery: patients will receive surgery.
干预措施: Carboplatin (Drug)
Carboplatin +Etoposide +surgery
Neoadjuvant therapy: Carboplatin, 75 mg/m^2 on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m^2 on Day 1 of every 3-day cycle, 2 cycles.
Surgery: patients will receive surgery.
干预措施: Etoposide (Drug)
结局指标
主要结局
Disease free survival（DFS）
时间窗: 12 months
To assess disease free survival（DFS）after surgery.
次要结局
- Objective response rate (ORR)(3 months)
- Overall survival (OS)(24 months)
- Disease control rate (DCR)(3 months)
- Complete pathological response (CPR）(3 months)
- Major pathological response (MPR)(3 months)
- Duration of response (DOR)(3 months)
研究者
Yayi He
Professor
Shanghai Pulmonary Hospital, Shanghai, China