Titre 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)
Protocole ID BO29554 (B-FAST)
ClinicalTrials.gov ID NCT03178552
Type(s) de cancer Poumon non à petites cellules
Phase Phase II
Stade Maladie avancée ou métastatique
Type étude Traitement
Médicament Alectinib vs Atezolizumab vs Pemetrexed vs Cisplatine vs vs Carboplatine vs Gemcitabine
Institution INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE DE QUEBEC - UL  
Ville Québec
Investigateur(trice) principal(e) Dre Catherine Labbé
Coordonnateur(trice) Brigitte Fortin
 418-656-8711 poste 2639
Statut Fermé
Critètes d'éligibilité
  • No prior systemic treatment for unresectable stage IIIB or IV NSCLC
  • 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
Critètes d'exclusion
  • Inability to swallow oral medication
  • Women who are pregnant or lactating
  • Symptomatic, untreated CNS metastases
  • 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