这是一项第三期随机开放标签研究，旨在比较 JDQ443 单药治疗与 docetaxel 在携带 KRAS G12C 突变的晚期非小细胞肺癌（NSCLC）患者中的疗效，这些患者先前曾接受含铂化疗及免疫检查点抑制剂治疗（序贯或联合）。
适应症：Non-Small Cell Lung Cancer
入组条件
纳入标准
- Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
- Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novartis designated central laboratory or by accepted local tests.
- Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease
- Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit.
排除标准
- Participants who have previously received docetaxel (except if received in neoadjuvant or adjuvant setting with no progression within 12 months after the of end of treatment), or any other KRAS G12C inhibitor.
- Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other druggable alterations will be excluded if required by local guidelines.
- Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Participant has an history of interstitial lung disease or pneumonitis grade \> 1.
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。