招募中 NCT05920356

一項評估Sotorasib Platinum Doublet組合與Pembrolizumab Platinum Doublet組合作為IV期或IIIB/C期非鱗狀非小細胞肺癌參與者一線治療的研究( CodeBreaK 202 )

非小細胞肺癌神經內分泌腫瘤Phase IIIIII 期IV 期KRASPD-L1

主要目的是比較接受sotorasib加鉑金雙劑化療的參與者與接受pembrolizumab加鉑金雙劑化療的參與者的無惡化生存期(PFS)和總生存期(OS)。

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

收案條件

納入條件

  • 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

排除條件

  • 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

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。