本研究为一项随机、双盲、多中心、第三期临床研究,旨在比较 Serplulimab + 化疗 + 同步放射治疗与化疗 + 同步放射治疗于局限期小细胞肺癌受试者中的临床疗效与安全性。
适应症:Limited-Stage Small Cell Lung Cancer
入组条件
纳入标准
- 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.
入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。