A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (B-FAST)

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223780

Enrollment

580

Registered

2018-01-17

Start date

2018-04-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : Atezolizumab INN of investigational material : Atezolizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory exploratory Progression Free Survival, Overall Response Rate RECIST v1.1	—

Secondary

Measure	Time frame
safety efficacy exploratory pharmacokinetics pharmacogenomics other Overall Survival etc. Observation	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026