Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and
delivers a dose of chemotherapy directly to the tumor. 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 tumors from growing, or if the tumors 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:
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
After stopping treatment, participants will visit the study clinic for a check-up 30 days
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:
All participants will be asked to take brigatinib or alectinib at the same time each day
throughout the study.
This multi-center 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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.