A Study of TAK-788 in Japanese Adults With Non-Small Cell Lung Cancer
Status:
Active, not recruiting
Trial end date:
2024-03-31
Target enrollment:
Participant gender:
Summary
This study is in 2 parts. Different participants will take part in the 1st and 2nd parts of
the study.
The main aim of the 1st part of the study is to check how much TAK-788 adults with non-small
cell lung cancer (NSCLC) can receive without getting side effects from it.
The main aim of the 2nd part of the study is to learn if the condition of adults with
non-small cell lung cancer improves after treatment with TAK-788. Another aim is to continue
checking for side effects from TAK-788.
In the 1st part of the study, at the first visit, the study doctor will check who can take
part. For those that can take part, participants will take a capsule of TAK-788 once a day
for 28 days. This will count as 1 cycle. Different small groups of participants will receive
lower to higher doses of TAK-788. The study doctors will check for side effects after each
dose of TAK 788. In this way, researchers can work out the best dose of TAK-788 to give
participants in the 2nd part of the study.
Participants will visit the clinic 30 days after their treatment has finished for a final
check-up.
In the 2nd part of the study, at the first visit, the study doctor will check who can take
part. Participants will receive the best dose of TAK-788 worked out from the 1st part of the
study. Participants will receive TAK-788 in the same way as those from the 1st part of the
study. The study doctors will learn if the condition of these participants improves after
treatment with TAK-788. The study doctors will also check for side effects from TAK-788.
After treatment has finished, participants will visit the clinic every 12 weeks until the end
of the study.
In both parts of the study, participants can receive TAK-788 for up to just over 1 year, or
longer if their condition stays improved.