招募中 NCT07541170

一项评估Divarasib在已切除II-III期KRAS G12C阳性非小细胞肺癌(NSCLC)受试者中与研究者选择免疫疗法或观察相比的有效性和安全性的研究

非小细胞肺癌肉瘤Phase IIIII 期III 期IV 期KRASPD-L1

本研究的主要目的是评估divarasib与研究者选择免疫疗法( 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 )阳性II-IIIB期NSCLC的参与者中观察的有效性,无论肿瘤程式性死亡配体1 ( PD-L1 )状态如何,在新辅助化学免疫后未达到病理完全反应( pCR )

适应症:Non-small Cell Lung Cancer

入组条件

纳入标准

  • 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

排除标准

  • 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

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。