A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 511
- 试验地点
- 252
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.
详细描述
Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.
Arm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female, aged ≥18 years when signing the ICF.
- •Histologically diagnosed with SCLC.
- •Diagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.
- •Major organs are functioning well.
排除标准
- •Histologically or cytologically confirmed mixed SCLC.
- •Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
- •Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.
- •Patients with other active malignancies within 5 years or at the same time.
- •Subjects with known history of severe allergy to any monoclonal antibody.
- •Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
- •In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.
研究组 & 干预措施
Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
干预措施: HLX10 (Drug)
Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
干预措施: carboplatin/cisplatin-etoposide (Drug)
Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
干预措施: Thoracic radiotherapy (Radiation)
Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
干预措施: Prophylactic Cranial Irradiation (PCI) (Radiation)
placebo + carboplatin/cisplatin-etoposide + radiotherapy
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
干预措施: carboplatin/cisplatin-etoposide (Drug)
placebo + carboplatin/cisplatin-etoposide + radiotherapy
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
干预措施: Thoracic radiotherapy (Radiation)
placebo + carboplatin/cisplatin-etoposide + radiotherapy
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
干预措施: Placebo (Drug)
placebo + carboplatin/cisplatin-etoposide + radiotherapy
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
干预措施: Prophylactic Cranial Irradiation (PCI) (Radiation)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to approximately 24months
PFS, assessed by the Blinded Independent Central Review (BICR) as per RECIST v1.1
Overall survival (OS)
时间窗: up to 36 months
the time from randomization to death due to any cause
次要结局
- Progression-free survival(up to approximately 24months)
- Objective response rate (ORR)(up to approximately 24months)
- Duration of remission (DOR)(up to approximately 24months)