這是一項第2/3期、全球性、多中心、開放標籤、多隊列研究,旨在評估標靶治療或免疫治療作為單藥或聯合方案,用於經血液為本的次世代基因定序(NGS)循環腫瘤DNA(ctDNA)檢測確定帶有致癌體細胞突變或腫瘤突變負荷(TMB)檢測呈陽性的不可切除、晚期或轉移性NSCLC參與者的安全性及療效。
適應症:Non-Small Cell Lung Cancer
收案條件
納入條件
- 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
排除條件
- 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
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。