Summary
Genes give your body instructions on how to make proteins. Proteins are needed to keep
the body working properly. Many types of cancer are caused by changes in certain genes,
making them faulty. Some people with non small cell lung cancer (NSCLC) have a faulty ALK
gene. ALK stands for anaplastic lymphoma kinase. People with NSCLC who have the faulty
ALK gene are called ALK-positive. ALK inhibitors are an approved treatment for people
with ALK positive NSCLC. Some people stop responding to treatment with ALK inhibitors
over time due to more changes happening in their faulty ALK gene, so there is an unmet
medical need. Gilteritinib is an approved treatment for people with acute myeloid
leukemia (AML) with the faulty FLT3 gene who haven't responded to previous treatment, or
their cancer came back after previous treatment. Gilteritinib also blocks changes in the
ALK gene which could help people with ALK-positive NSCLC. A study needs to be done with
gilteritinib in people with ALK-positive NSCLC.
The main aim of the study is to check the safety of gilteritinib in people with
ALK-positive NSCLC and if they tolerate gilteritinib.
People in this study will be adults with locally advanced or metastatic ALK-positive
non-small cell lung cancer (NSCLC). Locally advanced means the cancer has spread to
nearby tissue. Metastatic means the cancer has spread to other parts of the body. They
have stopped responding to treatment with ALK inhibitors, including alectinib or
lorlatinib, over time. The key reasons people cannot take part are if they have
symptomatic cancers in the brain or nervous system, their cancer has spread to the thin
tissue that covers the brain and spinal cord (leptomengingeal metastasis), have recently
had or planning to have major surgery, have certain heart conditions, or have recently
had an infection, a stroke or mini-stroke.
People in the study will take tablets of gilteritinib once a day in a 28-day cycle. They
may be given up to 2 different doses of gilteritinib. People in the study will start on
the lower dose but can eventually switch to the higher dose if they tolerate the lower
dose and meet the safety checks.
Whilst taking gilteritinib, people will have regular scans of their tumors. People will
continue taking gilteritinib until their cancer gets worse, they have medical problems
from gilteritinib that they can't tolerate, they ask to stop taking gilteritinib, they
start other cancer treatment or, sadly pass away. People will visit the clinic about 7
days and then 30 days after they stop taking gilteritinib. They will be asked about any
medical problems and will have a safety check. After this, people who stopped taking
gilteritinib, but their cancer hadn't become worse, will continue to have regular scans
of their tumors. If their cancer does get worse, they will no longer have scans of their
tumors. After finishing gilteritinib, people will be phoned every 12 weeks to check on
their health. People will be in the study for up to 4 years, depending on how they
respond to gilteritinib.