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。