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Clinical Trials List

Protocol NumberBO29554
NCT Number(ClinicalTrials.gov Identfier)NCT03178552
Active

2018-12-01 - 2027-12-31

Phase II/III

Recruiting4

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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 (BFAST: BLOOD FIRST ASSAY SCREENING TRIAL)

  • Trial Applicant

  • Sponsor

    ROCHE PRODUCTS LTD.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/21

Investigators and Locations

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

1 Recruiting

Audit

None

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang
Linkou Chang Gung Medical Foundation

Taiwan National PI

楊政達

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

7 Recruiting

Audit

None

Condition/Disease

Non-Small Cell Lung Cancer

Objectives

This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by a blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assay.

Test Drug

Bevacizumab
GDC-6036、Docetaxel
Tencentriq、Carboplatin-GRY、Cisplatin NeoCorp、Gitrabin、Alimta、Entrectinib

Active Ingredient

Bevacizumab
GDC-6036
Docetaxel
Atezolizumab
Carboplatin
Cisplatin
Entrectinib
Gemcitabine
Pemetrexed

Dosage Form

Injections
Granules
Injections

Dosage

400mg/16 ml
100mg/Tablet
80mg/ 4ml
1200mg/20ml
450mg/45ml
100mg/100ml
1000mg
500mg
200mg

Endpoints

Cohort A: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 Baseline up to disease progression or death (up to approximately 6 years)
Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1 Baseline up to disease progression or death (up to approximately 6 years)
Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on RECIST v1.1 in bTMB PP1 Baseline up to disease progression or death (up to approximately 6 years)
Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1 Baseline up to disease progression or death (up to approximately 6 years)
Cohort E: Time in Response (TIR) as Assessed by the Investigator Based on RECIST v1.1 Month 12
Cohort F: Investigator-Assessed Objective Response Rate (ORR) Based on RECIST v1.1 Baseline up to disease progression or death (up to approximately 6 years)
Cohort G: Incidence of Adverse Events (AEs) Baseline to last dose of study treatment + 30 days or until initiation of new anticancer therapy, whichever occurs first (up to approximately 6 years)

Inclution 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
Symptomatic, untreated CNS metastases
History of malignancy other than NSCLC 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 active or uncontrolled human immunodeficiency virus (HIV) infection
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

The Estimated Number of Participants

  • Taiwan

    37 participants

  • Global

    650 participants

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