进行中(不再招募) NCT03319940

评估 Tarlatamab 用于小细胞肺癌(SCLC)成人患者的安全性、耐受性及药物动力学(PK)的研究

肺癌Phase I

一项评估 Tarlatamab 用于 SCLC 患者的安全性、耐受性及药物动力学的研究。

适应症:Small Cell Lung Carcinoma

入组条件

纳入标准

  • Participant has provided informed consent prior to initiation of any study-specific activities/procedures
  • Age greater than or equal to 18 years old at the time of signing the informed consent
  • Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Participants with treated brain metastases are eligible provided they meet defined criteria
  • Adequate organ function as defined in protocol

排除标准

  • History of other malignancy within the past 2 years prior to first dose of tarlatamab with exceptions
  • Major surgery within 28 days of first dose tarlatamab
  • Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not).
  • Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
  • Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab
  • Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
  • Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration

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。