癌研連線CancerLink
进行中（不再招募） NCT05450692

一项第三期研究，评估 ceralasertib 加 durvalumab 对比 docetaxel 用于既往接受抗 PD-(L)1 治疗及铂类化疗后疾病进展的非小细胞肺癌（NSCLC）患者

非小细胞肺癌淋巴瘤Phase IIIIII 期IV 期EGFRALK

本研究将评估 ceralasertib 与 durvalumab 联合治疗对比标准治疗 docetaxel，用于既往接受抗 PD-(L)1 治疗及铂类化疗后疾病进展的局部晚期及转移性 NSCLC 患者的疗效及安全性。

适应症：Advanced or Metastatic Non-Small Cell Lung Cancer

入组条件

纳入标准

  • Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
  • Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.
  • Documented radiological PD whilst on or after receiving the most recent treatment regimen.
  • Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
  • Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
  • Adequate organ function and marrow reserve
  • Minimum life expectancy of 12 weeks.
  • Body weight \> 30 kg and no cancer-associated cachexia.
  • Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).

排除标准

  • Participant with mixed SCLC and NSCLC histology.
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention.
  • Persistent toxicities (CTCAE Grade \> 2) caused by previous anticancer therapy.
  • Active or prior documented autoimmune or inflammatory disorders.
  • Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
  • Participants:
  • Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
  • All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
  • Must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy.
  • Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \> 10 mg prednisone or equivalent per day.
  • Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
  • Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.

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。