癌研連線CancerLink
已完成 NCT04262856

評估單藥治療及聯合免疫治療用於 PD-L1 陽性非小細胞肺癌參與者的研究

非小細胞肺癌前列腺癌淋巴瘤膀胱癌／泌尿道上皮癌皮膚癌Phase IIIII 期IV 期EGFRALKPD-L1

這項隨機第二期開放標籤研究將評估 zimberelimab（AB122）單藥治療、domvanalimab（AB154）聯合 zimberelimab，以及 domvanalimab 聯合 zimberelimab 及 etrumadenant（AB928）用於第一線、PD-L1 陽性、轉移性非小細胞肺癌的安全性與療效。

適應症：Non Small Cell Lung Cancer、Nonsquamous Non Small Cell Lung Cancer、Squamous Non Small Cell Lung Cancer、Lung Cancer

收案條件

納入條件

  • Male or female participants; age ≥ 18 years
  • Histologically confirmed, treatment naive, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Must have at least 1 measurable lesion per RECIST v1.1
  • Adequate organ and marrow function

排除條件

  • Use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (IMPs)
  • Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption)
  • History of trauma or major surgery within 28 days prior to the first dose of IMP
  • Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications
  • Positive test results for Hepatitis B surface antigen, Hepatitis C virus antibody with presence of Hepatitis C qualitative RNA or human immunodeficiency virus (HIV-1 and/or HIV-2) antibody at screening
  • Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
  • Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer

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。