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

Official Title

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

Summary:

The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumours (Response Evaluation Criteria in Solid Tumours [RECIST]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.

Trial Description

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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society