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 (B-FAST: Blood-First Assay Screening Trial)

CHUGAI PHARMACEUTICAL CO., LTD.0 个研究点目标入组 580 人开始时间: 2018年1月17日最近更新: 2023年10月17日

研究概览

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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
•- 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

•- Inability to swallow oral medication
•- Women who are pregnant or lacting
•- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
•- History of malignancy other than NSLCL 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 human immunodeficiency virus (HIV) positivity or autoimmune deficiency syndrome (AIDS)-related illness
•- 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

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