Addition of High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy to the Maintenance Therapy with PD-L1 Inhibitor Versus PD-L1 Inhibitor Alone for Extensive Stage Small Cell Lung Cancer (STONE-001)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 182
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study is expected to enroll 182 patients with partial response or stable disease after first-line immunochemotherapy for extensive-stage small cell lung cancer and eligible for thoracic consolidation radiotherapy within 2 years. Patients were randomized 2:1 to immune single-agent maintenance therapy in combination with hyperfractionated high-dose radiotherapy and immune single-agent maintenance therapy after being assessed by the investigator as otherwise eligible for enrollment. Patients in both arms received maintenance therapy with the PD-L1 inhibitor, atezolizumab or dulvedolizumab, until disease progression, unacceptable toxicity, or loss of clinical benefit. Patients in the combined radiotherapy arm required hyperfractionated high-dose (54 Gy) radiotherapy twice daily for residual disease in the chest. Each patient will be followed for approximately 2 years.
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
- •Fully informed written consent.
- •Age ≥ 18 years.
- •Confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC).
- •No previous systemic therapy except for induction immunochemotherapy for ES-SCLC.
- •Partial response or stable disease after 4-6 cycles of induction immunochemotherapy (PD-L1 inhibitor + cisplatin/carboplatin + etoposide). No more than 28 days between last tumor assessment before randomization and randomization.
- •Eligible for thoracic radiotherapy as assessed by the radiotherapy physician (The dose limits predicted for the organs at risk are as follows: bilateral lung V20 ≤ 25%, V5 ≤ 48%).
- •Patients with stable, asymptomatic CNS metastases are allowed.
- •Adequate bone marrow, renal function, and hepatic function.
- •Male or female patients of childbearing potential volunteered to use effective contraception during the study and within 6 months of the last dose of study drug.
排除标准
- •Prior thoracic radiotherapy.
- •History of interstitial lung disease (including but not limited to idiopathic pulmonary fibrosis), pneumonitis, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- •Positive testing for hepatitis B virus surface antigen (HBV sAg), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus (HIV).
- •Leptomeningeal metastasis.
- •Uncontrolled tumor-related pain.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
- •Malignancies other than NSCLC within 5 years prior to enrollment, with the exception of those treated with expected curative outcome.
- •Active or history of autoimmune disease or immune deficiency.
- •Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina.
- •Major surgical procedure other than for diagnosis within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the course of the study.
研究组 & 干预措施
Addition of thoracic consolidation radiotherapy to the maintenance therapy with PD-L1 inhibitor
干预措施: High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy (Radiation)
Addition of thoracic consolidation radiotherapy to the maintenance therapy with PD-L1 inhibitor
干预措施: atezolizumab or durvalumab (Drug)
Maintenance therapy with PD-L1 inhibitor
干预措施: atezolizumab or durvalumab (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: From randomization to the date of death due to any cause, assessed up to 4 years
次要结局
- Progression-free survival (PFS)(From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 4 years)
- Landmark analyses of survival(1-year and 2-year landmark analysis of OS and 6-month and 1-year landmark analysis of PFS)
- Best overall response (BOR)(Up to 4 years)
- Confirmed objective response rate (cORR)(Up to 4 years)
- Incidence and severity of adverse events(From randomization to 30 days after the end of study treatment)
研究者
Anhui Shi, MD
Chief Physician of Radiotherapy Department
Peking University Cancer Hospital & Institute