癌研連線CancerLink
進行中（不再收案） NCT05211895

一項全球性研究，評估 Durvalumab + Domvanalimab 於同步化放療後用於第三期不可切除 NSCLC 參與者的效果

非小細胞肺癌黑色素瘤Phase IIIIII 期IV 期EGFRALKPD-L1

這是一項第三期、隨機、雙盲、安慰劑對照、多中心、國際性研究，評估 durvalumab (MEDI4736) 與 domvanalimab (AB154) 相比 durvalumab 加安慰劑，用於局部晚期（第三期）、不可切除 NSCLC 成人患者，其疾病在接受確定性含鉑同步化放療 (cCRT) 後未出現惡化。

適應症：Non-Small Cell Lung Cancer

收案條件

納入條件

  • 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

排除條件

  • 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.

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。