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) - A Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients

F. HOFFMANN - LA ROCHE LTD.0 个研究点目标入组 660 人开始时间: 2021年6月17日最近更新: 2021年8月24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
•- Age >=18 years
•- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
•- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 284
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 284

•- 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 HIV positivity or 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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