A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

Titre officiel

Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

Sommaire:

L’objectif principal de cette étude est de déterminer l’efficacité du brigatinib selon le taux de réponse objective (TRO), celle-ci confirmée au moyen des critères RECIST (Response Evaluation Criteria in Solid Tumours), chez des participants atteints d’un CPNPC localement avancé ou métastatique positif pour la kinase ALK et dont la maladie a progressé pendant le traitement par l’alectinib ou le céritinib.

Description de l'essai

Primary Outcome:

  • Confirmed Objective Response Rate (ORR) Using RECIST v1.1 as Assessed by the Independent Review Committee (IRC)
Secondary Outcome:
  • Confirmed ORR Using RECIST v1.1 as Assessed by the Investigator
  • Duration of Response (DOR) as Assessed by the Investigator and IRC
  • Progression-Free Survival (PFS) as Assessed by the Investigator and IRC
  • Disease Control Rate (DCR) as Assessed by the Investigator and IRC
  • Time to Response as Assessed by the Investigator and IRC
  • Confirmed Intracranial Objective Response Rate (iORR) in Participants With Brain Metastases at Baseline, as Assessed by the IRC
  • Duration of Intracranial Response in Participants With Brain Metastases at Baseline, as Assessed by the IRC
  • Intracranial Progression-Free Survival (iPFS) in Participants With Brain Metastases at Baseline, as Assessed by the IRC
  • Overall Survival (OS)
  • Number of Participants With One or More Treatment-emergent Adverse Event (TEAE)
  • Health-Related Quality of Life (HRQOL) from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
  • HRQOL from EORTC QLQ- Lung Cancer (LC) 13
The drug being tested in this study is called brigatinib (AP26113). Brigatinib is being tested to treat people who have anaplastic lymphoma kinase-positive (ALK+), advanced non-small-cell lung cancer (NSCLC). The study will enroll approximately 103 patients. Participants will be assigned to the treatment group: • Brigatinib All participants will be asked to take brigatinib 90 mg tablet in lead-in period for 7 days, followed by brigatinib 180 mg at the same time each day throughout the study. This multicentre trial will be conducted worldwide. The overall time to participate in this study is approximately 5 years, but the total sample size and study duration may be adjusted according to preliminary data from interim analysis. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.

Voir cet essai sur ClinicalTrials.gov

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