A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

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:

Brigatinib is a medicine that binds to the surface of tumour cells in some cancers and delivers a dose of chemotherapy directly to the tumour. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumours from growing, or if the tumours have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: - Brigatinib tablets - Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later.

Trial Description

Primary Outcome:

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

Secondary Outcome:

• Overall Survival (OS)
• PFS as Assessed by Investigator per RECIST v1.1
• Objective Response Rate (ORR) as Assessed by Investigator and BIRC per RECIST v1.1
• Duration of Response (DOR) as Assessed by Investigator and BIRC
• Time to Response as Assessed by Investigator and 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
• Time to Intracranial Disease Progression (iPD) as Assessed by 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 in the United States, Argentina, Austria, Canada, Chile, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Mexico, Romania, Russia, South Korea, Spain, Sweden, Taiwan, and 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