进行中(不再招募) NCT03178552

一项评估多种靶向治疗作为非小细胞肺癌(NSCLC)参与者治疗的疗效及安全性的研究

非小细胞肺癌Phase IIIII 期IV 期TMB

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。