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)

Roche Farma S.A (Soc.Unipersonal) que realiza el ensayo0 个研究点目标入组 568 人开始时间: 2017年5月31日最近更新: 2017年9月4日

试验速览

暂无简介。

•- 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
•- 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 other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, limited stage bladder cancer, Stage I uterine cancer, or other cancers from which the patient has been disease-free for at least 2 years
•-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

发起方

Roche Farma S.A (Soc.Unipersonal) que realiza el ensayo