癌研連線CancerLink
进行中（不再招募） NCT05211895

一项全球性研究，评估 Durvalumab + Domvanalimab 于同步化放疗后用于第三期不可切除 NSCLC 参与者的效果

非小细胞肺癌黑色素瘤Phase IIIIII 期IV 期EGFRALKPD-L1

这是一项第三期、随机、双盲、安慰剂对照、多中心、国际性研究，评估 durvalumab (MEDI4736) 与 domvanalimab (AB154) 相比 durvalumab 加安慰剂，用于局部晚期（第三期）、不可切除 NSCLC 成人患者，其疾病在接受确定性含铂同步化放疗 (cCRT) 后未出现恶化。

适应症：Non-Small Cell Lung Cancer

入组条件

纳入标准

  • Participant must be ≥ 18 years at the time of screening.
  • Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
  • Provision of a tumour tissue sample obtained prior to CRT
  • Documented tumour PD-L1 status ≥ 1% by central lab
  • Documented EGFR and ALK wild-type status (local or central).
  • Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
  • Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
  • Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
  • WHO performance status of 0 or 1 at randomization
  • Adequate organ and marrow function

排除标准

  • History of another primary malignancy, except for:
  • Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence.
  • Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease .
  • Adequately treated carcinoma in situ, including Ta tumors without evidence of disease.
  • Mixed small cell and non-small cell lung cancer histology.
  • Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
  • Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
  • Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia).
  • Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.
  • History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis
  • Active or prior documented autoimmune or inflammatory disorders (with exceptions)
  • Active EBV infection, or known or suspected chronic active EBV infection at screening
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

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。