这是一项第2/3期、全球性、多中心、开放标签、多队列研究,旨在评估靶向治疗或免疫治疗作为单药或联合方案,用于经血液为本的次世代基因测序(NGS)循环肿瘤DNA(ctDNA)检测确定带有致癌体细胞突变或肿瘤突变负荷(TMB)检测呈阳性的不可切除、晚期或转移性NSCLC参与者的安全性及疗效。
适应症:Non-Small Cell Lung Cancer
入组条件
纳入标准
- Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Measurable disease
- Adequate recovery from most recent systemic or local treatment for cancer
- Adequate organ function
- Life expectancy greater than or equal to (\>/=) 12 weeks
- For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception
排除标准
- Inability to swallow oral medication
- Women who are pregnant or lactating
- Symptomatic, untreated CNS metastases
- History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
- Known active or uncontrolled human immunodeficiency virus (HIV) infection
- Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
- Inability to comply with other requirements of the protocol
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。