Adebrelimab and Concurrent Radiochemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- 6-m PFS rate
研究概览
简要总结
Patients with extensive-stage small-cell lung cancer (ES-SCLC) have poor prognosis, with limited treatment options. Chemo-immunotherapy is the standard 1st-line therapy for patients with ES-SCLC.When 4 cycles of etoposide+carboplatin (EC) or etoposide+cisplatin(EP) chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy.
In this study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC chemotherapy plus Adebrelimab, participants with response（PR/CR/SD）will receive concurrent radiotherapy and 2 cycles of EC chemotherapy plus Adebrelimab, then maintenance therapy with Adebrelimab （Q3W）.
The purpose of this study is to explore the safety and efficacy of Adebrelimab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.
详细描述
Participants receive EC chemotherapy combined with Adebrelimab for 2 cycles, and the efficacy will be evaluated. If the efficacy evaluation is SD/PR/CR, concurrent chemoradiotherapy combined with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy + Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.
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
- •Aged 18-75 years;
- •Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system) ;
- •Must sign a written informed consent form prior to any study specific procedures;
- •No prior treatment for ES-SCLC;
- •No more than 5 lesions (including metastases),and at least one measurable lesion that meets RECIST 1.1 evaluation criteria;
- •Life expectancy more than 3 months;
- •ECOG PS 0-1
排除标准
- •Previous treatment with radiochemotherapy for limited-stage small cell lung cancer;
- •Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy ;
- •Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;
- •Active brain metastases, Leptomeningeal metastasis(untreated central nervous system (CNS) metastases unless asymptomatic and lesion size<1cm;
- •Patients with spinal cord compression;
- •Patients with multiple liver metastases(except isolated lesion and lesion size<2cm);
- •Uncontrollable third cavity effusion (e.g. a large amount of pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which was judged by the investigator to be unsuitable for study;
- •The investigator judges that there are any patients who endanger the patient's safety, interfere with the study assessment, and have poor compliance.
研究组 & 干预措施
Treatment (etoposide, carboplatin, radiation, Adebrelimab)
Participants receive etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.
干预措施: Adebrelimab (Drug)
Treatment (etoposide, carboplatin, radiation, Adebrelimab)
Participants receive etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.
干预措施: Radiation Therapy (Radiation)
Treatment (etoposide, carboplatin, radiation, Adebrelimab)
Participants receive etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.
干预措施: etoposide, carboplatin(EC) (Drug)
结局指标
主要结局
6-m PFS rate
时间窗: 6 months
6-m PFS rate is defined as the percentage of participants whose disease is still progression-free at the 6th month
次要结局
- ORR(up to 24 months.)
- 12-m PFS rate(12 months)
- PFS(From date of the first treatment to the first documented disease progression, assessed up to 24 months)
- OS(From date of the first treatment to death due to any cause, assessed up to 24 months)
- AEs(up to 24 months)