招募中 NCT05920356

一项评估Sotorasib Platinum Doublet组合与Pembrolizumab Platinum Doublet组合作为IV期或IIIB/C期非鳞状非小细胞肺癌参与者一线治疗的研究( CodeBreaK 202 )

非小细胞肺癌神经内分泌肿瘤Phase IIIIII 期IV 期KRASPD-L1

主要目的是比较接受sotorasib加铂金双剂化疗的参与者与接受pembrolizumab加铂金双剂化疗的参与者的无恶化生存期(PFS)和总生存期(OS)。

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

入组条件

纳入标准

  • Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
  • No history of systemic anticancer therapy in metastatic/non-curable settings
  • Eastern Cooperative Oncology Group (ECOG) ≤ 1

排除标准

  • Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
  • Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy
  • Symptomatic (treated or untreated) brain metastases
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication
  • Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
  • Prior therapy with a KRAS G12C inhibitor

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。