癌研連線CancerLink
已完成 NCT04619797

Tiragolumab 聯合 Atezolizumab 加 Pemetrexed 及 Carboplatin/Cisplatin 與 Pembrolizumab 加 Pemetrexed 及 Carboplatin/Cisplatin 比較用於未曾接受治療的晚期非鱗狀非小細胞肺癌參與者之研究

非小細胞肺癌淋巴瘤Phase IIIII 期IV 期EGFRALKROS1PD-L1

本研究目的為評估 tiragolumab 聯合 atezolizumab 加 pemetrexed 及 carboplatin/cisplatin（A 組）與安慰劑聯合 pembrolizumab 加 pemetrexed 及 carboplatin/cisplatin（B 組）比較，用於未曾接受治療的局部晚期不可切除或轉移性非鱗狀非小細胞肺癌 (NSCLC) 參與者之療效、安全性及藥物動力學。 符合條件的參與者將被隨機

適應症：Non-small Cell Lung Cancer (NSCLC)

收案條件

納入條件

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
  • No prior systemic treatment for metastatic non-squamous NSCLC
  • Known tumor programmed death-ligand 1 (PD-L1) status
  • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
  • Life expectancy \>= 12 weeks
  • Adequate hematologic and end-organ function
  • Negative human immunodeficiency virus (HIV) test at screening
  • Serology test negative for active hepatitis B virus or active hepatitis C virus at screening.

排除條件

  • Mutations in epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene
  • Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • 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 randomization, with the exception of malignancies with a negligible risk of metastasis or death
  • Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
  • 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-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
  • Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the participant may receive during the study
  • Women who are pregnant, or breastfeeding
  • Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration.

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。