進行中(不再收案) NCT05353257

評估 Serplulimab 聯合化療及同步放射治療於局限期小細胞肺癌患者療效與安全性的研究

肺癌Phase III

本研究為一項隨機、雙盲、多中心、第三期臨床研究,旨在比較 Serplulimab + 化療 + 同步放射治療與化療 + 同步放射治療於局限期小細胞肺癌受試者中的臨床療效與安全性。

適應症:Limited-Stage Small Cell Lung Cancer

收案條件

納入條件

  • 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.

排除條件

  • 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.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。