招募中 NCT07541170

一項評估Divarasib在已切除II-III期KRAS G12C陽性非小細胞肺癌(NSCLC)受試者中與研究者選擇免疫療法或觀察相比的有效性和安全性的研究

非小細胞肺癌肉瘤Phase IIIII 期III 期IV 期KRASPD-L1

本研究的主要目的是評估divarasib與研究者選擇免疫療法( pembrolizumab或nivolumab )或在切除Kirsten大鼠肉瘤病毒癌基因同源物甘氨酸12至半胱氨酸( KRAS G12C )陽性II-IIIB期NSCLC的參與者中觀察的有效性,無論腫瘤程式性死亡配體1 ( PD-L1 )狀態如何,在新輔助化學免疫後未達到病理完全反應( pCR )

適應症:Non-small Cell Lung Cancer

收案條件

納入條件

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology
  • Participants must have had complete resection of NSCLC
  • Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based doublet chemotherapy
  • Participants must be randomized within 12 weeks of their surgery date
  • No evidence of disease recurrence or metastatic disease
  • Documentation of the presence of a KRAS G12C mutation

排除條件

  • Participants who achieve pCR following neoadjuvant treatment
  • Prior treatment with a KRAS inhibitor or any other anti-cancer therapy not otherwise specified in the protocol
  • Prior treatment with radiation therapy for NSCLC, with the exception of localized symptom-directed radiation prior to surgical resection
  • Resolved Grade 3 or greater immune-related AE or unresolved Grade 2 or greater immune-related AE from neoadjuvant immunotherapy
  • Active or history of autoimmune disease or immune deficiency
  • Significant cardiovascular disease

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。