An Efficacy Study Comparing Brigatinib Versus Alectinib in Advanced Anaplastic Lymphoma Kinase-Positive (ALK+) Non-Small-Cell Lung Cancer (NSCLC) Participants Who Have Progressed on Crizotinib

Official Title

A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIG®) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (XALKORI®)

Summary:

The purpose of this study is to compare the efficacy of brigatinib versus alectinib in participants with ALK+ locally advanced or metastatic NSCLC who have progressed on crizotinib as evidenced by progression-free survival (PFS) as assessed by response evaluation criteria in solid tumours (RECIST) v1.1.

Trial Description

Primary Outcome:

• PFS as Assessed by Blinded Independent Review Committee (BIRC) per RECIST v1.1

Secondary Outcome:

• Time to Intracranial Progression (iPD) as Assessed by BIRC per Modified RECIST v1.1
• Overall Survival (OS)
• Objective Response Rate (ORR) as Assessed by Investigator and BIRC per RECIST v1.1
• Time to Response as Assessed by Investigator and BIRC
• Duration of Response (DOR) as Assessed by BIRC
• Intracranial Objective Response Rate (iORR) as Assessed by BIRC per Modified RECIST v1.1
• Intracranial Duration of Response (iDOR) as Assessed by the BIRC per Modified RECIST v1.1
• Health-Related Quality of Life (HRQOL) from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 v3.0) Score
• HRQOL from EORTC QLQ- Lung Cancer (LC) 13

The drug being tested in this study is called brigatinib. Brigatinib has been demonstrated to benefit people with ALK+ NSCLC. The comparator drug is called alectinib. Alectinib has been demonstrated to benefit people with ALK+ NSCLC. Both drugs belong to a class of drugs called anaplastic lymphoma kinase (ALK) inhibitors. Both drugs are taken by mouth. Both drugs are approved by the United States Food and Drug Administration (US FDA). The study will enroll approximately 246 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1 ratio to one of the two treatment groups:

• Brigatinib

• Alectinib All participants will be asked to take brigatinib or alectinib at the same time each day throughout the study. This multi-centre trial will be conducted the United States, Argentina, Austria, Canada, Chile, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Mexico, Romania, Russia, South Korea, Spain, Sweden, Taiwan, Thailand. The overall time to participate in this study is 5 years. 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