A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (BFAST: Blood First Assay Screening Trial) - BO29554

F. Hoffmann-La Roche AG0 个研究点目标入组 616 人开始时间: 2024年4月29日最近更新: 2024年8月21日

适应症

试验速览

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•Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC, Measurable disease (as defined by RECIST, v1.1), Adequate recovery from most recent systemic or local treatment for cancer, Adequate organ function, Life expectancy >=12 weeks, For female patients of childbearing potential and male patients, willingness to use acceptable methods of contraception

•Inability to swallow oral medication, Women who are pregnant or lactating, Symptomatic, untreated CNS metastases Patients with treated and/or asymptomatic brain metastases may still be eligible for treatment on the study depending on individual cohort requirements; see the cohort-specific appendices for details regarding eligibility, History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate = 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ of breast, or Stage I uterine cancer, Significant cardiovascular disease, Known active or uncontrolled HIV infection

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