癌研連線CancerLink
进行中（不再招募） NCT05502237

zimberelimab与domvanalimab联合化疗对比pembrolizumab联合化疗用于未经治疗的转移性非小细胞肺癌患者

非小细胞肺癌淋巴瘤Phase IIIIII 期IV 期EGFRALKROS1BRAFRETNTRKPD-L1

本研究的主要目标为比较zimberelimab（ZIM）与domvanalimab（DOM）联合化疗，相较于pembrolizumab（PEMBRO）联合化疗，对无可行基因变异的未经治疗转移性非小细胞肺癌患者总生存期（OS）的影响。

适应症：Non-small Cell Lung Cancer

入组条件

纳入标准

  • Life expectancy ≥ 3 months.
  • Pathologically documented NSCLC that meets both of the criteria below:
  • Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition).
  • Have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations.
  • Have no actionable genomic alterations such as ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other driver oncogenes with approved frontline therapies.
  • Have not received prior systemic treatment for metastatic NSCLC.
  • Measurable disease per RECIST v1.1 criteria by investigator assessment.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  • Have adequate organ functions.

排除标准

  • Have mixed small-cell lung cancer (SCLC) and NSCLC histology.
  • Positive serum pregnancy test or individuals who are breastfeeding or have plans to breastfeed during the study period.
  • Received prior treatment with any anti-PD-1, anti-PD-L1, or any other antibody targeting an immune checkpoint.
  • Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
  • Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
  • Have an active autoimmune disease that required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
  • Are receiving chronic systemic steroids.
  • Have significant third-space fluid retention.
  • Have untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has had an allogenic tissue/solid organ transplant.
  • Have received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
  • Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

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。