进行中(不再招募) NCT03706690

Durvalumab 作为非小细胞肺癌患者巩固治疗的研究

非小细胞肺癌肉瘤Phase IIIIII 期IV 期PD-L1

这是一项第三期、随机、双盲、安慰剂对照、多中心研究,评估 durvalumab 对比安慰剂作为巩固治疗,用于局部晚期、不可切除的非小细胞肺癌(第三期)患者,这些患者在接受确定性铂类化放疗后未出现疾病进展。

适应症:Carcinoma, Non-Small-Cell Lung

入组条件

纳入标准

  • Age≥18 years
  • Documented NSCLC and present with locally advanced, unresectable (Stage III) disease;
  • Receipt of concurrent or sequential chemoradiation therapy,
  • No progression following definitive, platinum-based, concurrent or sequential chemoradiation therapy
  • World Health Organization (WHO) PS of 0 or 1;
  • No prior exposure to any anti CTLA-4, anti-PD-1, anti-PD-L1, or anti PD L2 antibodies, excluding therapeutic anticancer vaccines
  • Adequate organ and marrow function required
  • Life expectancy of at least 12 weeks
  • Tumor PD-L1 status, with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory, must be known prior to randomization.
  • Tumour sample requirements are as follows: Provision of a tumour tissue sample (newly acquired sample \<=3 months old is preferred, but an archived sample \<=6 months old is acceptable) in a quantity sufficient to allow for analysis.

排除标准

  • History of allogeneic organ transplantation, or another primary malignancy, or active primary immunodeficiency.
  • Active or prior documented autoimmune or inflammatory disorders
  • Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent
  • Active infection including tuberculosis hepatitis B hepatitis C (HCV), or human immunodeficiency virus (positive human immunodeficiency virus \[HIV\] 1/2 antibodies).
  • Mixed small cell and NSCLC histology, sarcomatoid variant
  • Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from the prior chemoradiation therapy.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.

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。