癌研連線CancerLink
已完成 NCT04262856

评估单药治疗及联合免疫治疗用于 PD-L1 阳性非小细胞肺癌参与者的研究

非小细胞肺癌前列腺癌淋巴瘤膀胱癌／尿路上皮癌皮肤癌Phase IIIII 期IV 期EGFRALKPD-L1

这项随机第二期开放标签研究将评估 zimberelimab（AB122）单药治疗、domvanalimab（AB154）联合 zimberelimab，以及 domvanalimab 联合 zimberelimab 及 etrumadenant（AB928）用于第一线、PD-L1 阳性、转移性非小细胞肺癌的安全性与疗效。

适应症：Non Small Cell Lung Cancer、Nonsquamous Non Small Cell Lung Cancer、Squamous Non Small Cell Lung Cancer、Lung Cancer

入组条件

纳入标准

  • 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

排除标准

  • 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

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。