Trial details

Trial short name: B-FAST

Official title: A Phase II/III Multicenter Study Evaluating The Efficacy And Safety of Multiple Targeted Therapies As Treatments for Patients With Advanced or Metastatis Non-Small Cell Cancer (NSCLC) Harboring ACtionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)

Principal Investigator: Dr. S. Cheng

Cancer type: Lung
Cancer location: Lung
Disease stage: Advanced Cancer
Trial phase: Phase 2, Phase 3
Intervention: Drug: Alectinib, Drug: Atezolizumab, Drug: Pemetrexed, Drug: Cisplatin, Drug: Carboplatin, Drug: Gemcitabine

Registration #: NCT03178552

Trial description:
The purpose of this study is to look at the effectiveness of targeted therapies or immunotherapy as single agents or in combination in patients with unresectable, advanced or metastatic NSCLC with oncogenic somatic mutations. Patients who meet a certain criteria may be able to participate. There will be 3 groups of patients participating in this study; two groups will receive Alectinib, and the third group will be randomized to receive Atezolizumab or standard of care chemotherapy (Cisplatin or Carboplatin plus Pemetrexed or Gemcitabine plus Cisplatin or Carboplatin). Patients participating will know which group they are assigned to but will be randomly allocated to one group or the other based on mutations.

Inclusion Criteria: • 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 Exclusion Criteria: • 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, 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