已完成 NCT04513925

Atezolizumab 及 Tiragolumab 与 Durvalumab 比较用于局部晚期、不可切除第三期非小细胞肺癌 (NSCLC) 参与者之研究

非小细胞肺癌淋巴瘤Phase IIIIII 期IV 期EGFRALKPD-L1

本研究目的为评估 atezolizumab 联合 tiragolumab 与 durvalumab 比较,用于已接受至少两个周期同步以铂类为基础的化学放射治疗 (CRT) 且未出现影像学疾病进展的局部晚期、不可切除第三期非小细胞肺癌 (NSCLC) 参与者之疗效与安全性。

适应症:Non-small Cell Lung Cancer (NSCLC)

入组条件

纳入标准

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
  • Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT)
  • At least two prior cycles of platinum-based chemotherapy administered concurrently with radiotherapy (RT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
  • The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (±10 percent \[%\]) gray (Gy) (54 Gy to 66 Gy) administered by intensity modulated RT (preferred) or 3D-conforming technique
  • No progression during or following concurrent platinum-based CRT
  • A known PD-L1 result
  • Life expectancy \>/= 12 weeks
  • Adequate hematologic and end-organ function
  • Female participants must be willing to avoid pregnancy for 90 days after the final dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months after the final dose of durvalumab
  • Male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab
  • Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab

排除标准

  • Any history of prior NSCLC and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)
  • NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
  • Any evidence of Stage IV disease
  • Treatment with sequential CRT for locally advanced NSCLC
  • Participants with locally advanced NSCLC who have progressed during or after the definitive cCRT prior to randomization
  • Any Grade \>2 unresolved toxicity from previous CRT
  • Grade \>= 2 pneumonitis from prior CRT
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis
  • History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death
  • Prior allogeneic stem cell or solid organ transplantation
  • Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1
  • Any prior Grade \>/= 3 immune-mediated adverse event or any unresolved Grade \> 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents
  • Treatment with systemic immunosuppressive medication
  • Women who are pregnant, or breastfeeding

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。