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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

Recruiting7

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 (B-FAST: Blood-First Assay Screening Trial)

  • Trial Applicant

  • Sponsor

    Hoffmann-La Roche

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
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 Division of Hematology & Oncology
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

Principal Investigator Chong-Jen Yu Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Po-Hao Feng Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Han-Lin Hsu Division of Thoracic Medicine
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-Small Cell Lung Cancer

Objectives

This study will evaluate the efficacy and safety of multiple therapies that are selected using predictive biomarkers identified via two blood-based, NGS assays in patients with previously untreated advanced NSCLC.

Test Drug

Tencentriq、Carboplatin-GRY、Cisplatin NeoCorp、Gitrabin、Alimta、Entrectinib、Cotellic、Zelboraf

Active Ingredient

Atezolizumab
Carboplatin
Cisplatin
Cobimetinib
Entrectinib
Gemcitabine
Pemetrexed
Vemurafenib

Dosage Form

Dosage

1200mg/20ml
450mg/45ml
100mg/100ml
1000mg
200mg
500mg
20mg
240mg

Endpoints

Primary Outcome Measures :
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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Month 12 ]
Cohort F: Investigator-Assessed Objective Response Rate (ORR) Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]

Secondary Outcome Measures :
All Cohorts: Duration of Response (DOR) as Assessed by the Investigator Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by the Investigator Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
Cohorts A, B, D, F: PFS as Assessed by the Investigator Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
All Cohorts: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by IRF Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
All Cohorts: PFS as Assessed by IRF Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
All Cohorts: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
All Cohorts: Overall Survival (OS) [ Time Frame: Baseline up to approximately 6 years ]
All Cohorts: Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to approximately 6 years ]
Cohorts A, B, D, E, F: Percentage of Participants with Improvement Compared with Baseline in Total Severity Symptom Score as Measured by Symptoms in Lung Cancer (SILC) Scale in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
All Cohorts: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by the SILC Scale [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
Cohorts C, E, F: Change from Baseline in Patient-Reported Lung Cancer Symptom (Cough, Dyspnea, Chest pain) Score as Measured by the SILC Scale [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
All Cohorts: Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30) [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
Cohorts A, B, D, E, F: Change from Baseline in HRQoL Scores as Measured by the SILC Scale [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
All Cohorts: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the EORTC QLQ-C30 [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
Cohorts A, B, D, E, F: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the SILC Scale [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
All Cohorts: Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
Cohort B: Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Day 1 to Day 28 of Cycle 1 (cycle length = 28 days) ]
Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib [ Time Frame: DFP: pre-dose (0 hours [hr]) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days) ]
DFP: Dose-Finding Phase; DEP: Dose-Expanding Phase.

Cohort B: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of Alectinib [ Time Frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days) ]
Cohort B: Time to Reach Cmax (Tmax) of Alectinib [ Time Frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days) ]
Cohort B: Half-Life (t1/2) of Alectinib [ Time Frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days) ]
Cohort B: Metabolite to Parent Exposure Ratio for AUC0-last [ Time Frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days) ]
Cohort B: Metabolite to Parent Exposure Ratio for Cmax [ Time Frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days) ]
Cohort C: Percentage of Participants with Objective Response as Assessed by the Investigator Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
Cohort C: Percentage of Participants Free from Disease Progression as Assessed by the Investigator Based on RECIST v1.1 at Months 6 and 12 [ Time Frame: Months 6, 12 ]
Cohort C: PFS as Assessed by the Investigator based on RECIST v1.1 in bTMB PP2 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
Cohort C: OS in bTMB PP2 [ Time Frame: Baseline up to approximately 6 years ]
Cohort D: Time to CNS progression as Assessed by the Investigator Based on RECIST v1.1 [ Time Frame: Baseline up to CNS progression (up to approximately 6 years) ]
Cohort D: Time to CNS progression as Assessed by the IRF Based on RECIST v1.1 [ Time Frame: Baseline up to CNS progression (up to approximately 6 years) ]
Cohorts D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-C30 [ Time Frame: Baseline, every 4 weeks until disease progression, up to approximately 6 years ]
Cohorts D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-BN20 [ Time Frame: Baseline, every 4 weeks until disease progression, up to approximately 6 years ]
Cohort D: Mean Plasma Concentration of Entrectinib [ Time Frame: Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days). ]
Cohort D: Mean Plasma Concentration of Entrectinib Metabolite M5 [ Time Frame: Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days). ]
Cohort E: TIR as Assessed by the Investigator Based on RECIST v1.1 [ Time Frame: Month 9 ]
Cohort E: TIR as Assessed by IRF [ Time Frame: Month 12 ]
Cohorts E, F: Serum Concentration of Atezolizumab [ Time Frame: Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days) ]
Cohort E, F: Change from Baseline in Anti-Drug Antibodies (ADAs) [ Time Frame: Baseline up to approximately 6 years ]

Inclution Criteria

General Inclusion Criteria
Patients must meet the following criteria to be eligible for blood-based NGS ctDNA
assay screening:
 Signed informed consent form for the blood-based screening part of the study and
willingness to participate in an assigned cohort based on their identified oncogenic
somatic mutation(s)
 Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not
amenable to treatment with combined modality chemoradiation (advanced) or
Stage IV (metastatic) NSCLC
Mixed tumors should be categorized according to the predominant cell type.
 No prior systemic treatment for unresectable Stage IIIb or IV 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, as demonstrated by the following clinical laboratory
parameters:
Hemoglobin  9 g/dL
ANC  1.0109
/L
Platelet count  75 109
/L
Serum AST and ALT 2.5 the upper limit of normal (ULN) or  5 ULN for
patients with concurrent liver metastases
Bilirubin  2 ULN or 5 ULN for patients with concurrent liver metastases
Serum creatinine 2 ULN or creatinine clearance  45 mL/min
 Life expectancy  12 weeks
 For female patients of childbearing potential and male patients, willingness to use
acceptable methods of contraception (see Appendix 3)
Additionally, in order to be enrolled on a treatment cohort of the study, patients must
meet the specific criteria for the respective treatment cohorts as provided in the following
appendices:
 Cohort A (ALK+): Appendix 8, Section 11.4.1.1
 Cohort B (RET+): Appendix 9, Section 12.4.1.1
 Cohort C (bTMB+): Appendix 10, Section 13.4.1.1
 Cohort D (ROS1): Appendix 11, Section 14.4.1.1
To be enrolled in a treatment cohort, patients must have met and continue to meet all
eligibility criteria specified above for the blood-based NGS ctDNA assay screenings.

Exclusion Criteria

General Exclusion Criteria
Patients who meet any of the following criteria will be excluded from participating in the
blood-based screening part of the study:
 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, 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
Patients with known coronary artery disease, congestive heart failure not
meeting the above criteria, or known left ventricular ejection fraction  50% must
be on a stable medical regimen that is optimized in the opinion of the treating
physician, in consultation with a cardiologist if appropriate.
 Known HIV positivity or AIDS-related illness
 Either a concurrent condition (including medical illness, such as active infection
requiring treatment with intravenous antibiotics or the presence of laboratory
abnormalities) 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
Additionally, patients who meet any of the cohort-specific exclusion criteria provided in
the following appendices will be excluded from that respective treatment cohort:
 Cohort A (ALK+): Appendix 8, Section 11.4.1.2
 Cohort B (RET+): Appendix 9, Section 12.4.1.2
 Cohort C (bTMB+): Appendix 10, Section 13.4.1.2
 Cohort D (ROS1): Appendix 11, Section 14.4.1.2
To be enrolled in a treatment cohort, patients must have met and continue to meet all
eligibility criteria specified above for the blood-based NGS ctDNA assay screenings.

The Estimated Number of Participants

  • Taiwan

    37 participants

  • Global

    660 participants

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