進行中(不再收案) NCT05186974

Sacituzumab Govitecan 聯合治療用於晚期或轉移性非小細胞肺癌(NSCLC)患者第一線治療的研究

非小細胞肺癌Phase IIIII 期IV 期

本臨床研究旨在進一步了解研究藥物 sacituzumab govitecan-hziy(SG)及其與 pembrolizumab 或 pembrolizumab 加鉑類藥物(carboplatin 或 cisplatin)聯合使用的劑量,用於晚期或轉移性(已擴散)非小細胞肺癌(NSCLC)患者。

適應症:Non-small Cell Lung Cancer

收案條件

納入條件

  • Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator
  • No prior systemic treatment for metastatic NSCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Adequate hematologic counts
  • Adequate hepatic function

排除條件

  • Mixed SCLC and NSCLC histology
  • Active second malignancy
  • NSCLC that is eligible for definitive local therapy alone
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has had an allogenic tissue/solid organ transplant.
  • Has severe (≥ Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient
  • Has received radiation therapy to the lung
  • Individuals may not have received systemic anticancer treatment within the previous 6 months
  • Is currently participating in or has participated in a study of an investigational agent
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Known active central nervous system (CNS) metastases
  • History of cardiac disease
  • Active chronic inflammatory bowel disease
  • Active serious infection requiring antibiotics
  • Active or chronic hepatitis B infection
  • Positive hepatitis C antibody
  • Positive serum pregnancy test or women who are lactating

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。