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

Titre officiel

A Phase II/III Multicentre 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)

Sommaire:

Étude multicentrique internationale ouverte de phase II/III à cohortes multiples visant à évaluer l’innocuité et l’efficacité de traitements ciblés ou de l’immunothérapie administrés en monothérapie ou en d’association chez des participants atteints de cancer du poumon non à petites cellules (CPNPC) non résécable, avancé ou métastatique comportant des mutations somatiques oncogènes ou positif à l’épreuve de mesure du fardeau mutationnel tumoral, d’après deux épreuves sanguines de séquençage de prochaine génération de l’ADN tumoral circulant (ADNtc).

Description de l'essai

Primary Outcome:

  • Cohort A: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the Response Evaluation Criteria in Solid Tumours (RECIST) Version (v) 1.1
  • Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the RECIST v1.1
  • Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on the RECIST v1.1
  • Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the RECIST v1.1
Secondary Outcome:
  • All Cohorts: Duration of Response as Assessed by the Investigator Based on the RECIST v1.1
  • Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by the Investigator Based on the RECIST v1.1
  • Cohorts A, B and D: PFS as Assessed by the Investigator Based on the RECIST v1.1
  • All Cohorts: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on the RECIST v1.1
  • Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by IRF Based on the RECIST v1.1
  • All Cohorts: PFS as Assessed by IRF Based on the RECIST v1.1
  • All Cohorts: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on the RECIST v1.1
  • All Cohorts: Overall Survival
  • All Cohorts: Percentage of Participants with Adverse Events
  • Cohorts A, B and D: Percentage of Participants who Have Shown 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)
  • All Cohorts: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by SILC Scale
  • Cohort C: Change from Baseline in Patient-Reported Lung Cancer Symptom (Cough, Dyspnea, Chest pain) Score as Measured by the SILC Scale
  • 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)
  • Cohorts A, B and D: Change from Baseline in HRQoL Scores as Measured by the SILC Scale
  • All Cohorts: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the EORTC QLQ-C30
  • Cohorts A, B and D: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the SILC Scale
  • All Cohorts: Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
  • Cohort B: Percentage of Participants with Dose-Limiting Toxicities (DLTs)
  • Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib
  • Cohort B: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of Alectinib
  • Cohort B: Time to Reach Cmax (Tmax) of Alectinib
  • Cohort B: Half-Life (t1/2) of Alectinib
  • Cohort B: Metabolite to Parent Exposure Ratio for AUC0-last
  • Cohort B: Metabolite to Parent Exposure Ratio for Cmax
  • Cohort C: Percentage of Participants with Objective Response as Assessed by the Investigator Based on the RECIST v1.1
  • Cohort C: Percentage of Participants Free from Disease Progression as Assessed by the Investigator Based on the RECIST v1.1 at Months 6 and 12
  • Cohort D: Time to CNS progression as Assessed by the Investigator Based on the RECIST v1.1
  • Cohort D: Time to CNS progression as Assessed by the IRF Based on the RECIST v1.1
  • Cohort D: Intracranial Tumour Response Rate as Assessed by the Investigator Based on the RECIST v1.1
  • 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
  • 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
  • Cohort D: Mean Plasma Concentration of Entrectinib
  • Cohort D: Mean Plasma Concentration of Entrectinib Metabolite M5

Voir cet essai sur ClinicalTrials.gov

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