进行中(不再招募) NCT05353257

评估 Serplulimab 联合化疗及同步放射治疗于局限期小细胞肺癌患者疗效与安全性的研究

肺癌Phase III

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。