A clinical trial to understand the effect of targeted therapies for patients with non-­small cell lung cancer with different mutations (BFAST: Blood First Assay Screening Trial)

A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (BFAST: Blood First Assay Screening Trial)

  • Cancer
  • Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Recruiting

This trial runs in
Cities
  • Brampton
  • Edmonton
  • Montréal
  • Oshawa
  • Saskatoon
  • Toronto
  • Winnipeg
Trial Identifier:

NCT03178552 2017-000076-28 BO29554

      Show trial locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      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 two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.

      Hoffmann-La Roche Sponsor
      Phase 2/Phase 3 Phase
      NCT03178552,BO29554,2017-000076-28 Trial Identifier
      Alectinib, Atezolizumab, Pemetrexed, Cisplatin, Carboplatin, Gemcitabine, Entrectinib, Cobimetinib, Vemurafenib, Bevacizumab, GDC-6036, Docetaxel Treatments
      Non-Small Cell Lung Cancer Condition
      Official Title

      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)

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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
      • 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 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

      For the latest version of this information please go to www.forpatients.roche.com

       

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