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。