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We are doing this study to find the most effective, safe dose of an experimental drug called raludotatug deruxtecan (the study drug) and to see if your disease or medical condition improves while taking it.
This study has two parts. The first part is called the Screening Period and lasts about 12 weeks. During this time, people will visit the doctor 5 to 7 times. They will have tests like checking their genes, memory tests, brain scans, a spinal tap, and other exams like blood tests and skin checks. The second part is called the Study Dosing Period. In this part, people will be randomly chosen to take either a study medicine or a fake pill that looks the same. They will take one pill every day for 5 to 8 years. During this time, they will go to the doctor every few months to answer questions, get exams, and have more tests like brain scans and lab work.
If you join this study, you will first go through screening to make sure the study is a good fit for you. After that, you will receive treatment and be followed over time. People are placed into treatment groups by chance and will get either a study medicine or a usual cancer treatment. The study has two parts. One part is for people whose cancer does not respond to platinum medicine, and the other part is for people whose cancer still responds to platinum medicine. Treatments are given through a vein, usually once every three weeks. During the study, you will go to regular clinic visits for checkups, blood tests, scans, and safety checks. Treatment will continue as long as it helps and the side effects stay manageable.
We are doing this study to collect data about the use and safety of the GORE TAG Conformable Thoracic Stent Graft®. This device is approved by the FDA for the endovascular repair of medical conditions of the aorta (the large blood vessel that runs inside the chest and abdomen).
In this study, people will be treated with the Gore TBE device as part of their regular surgery planned by their doctor. The study will collect information from normal follow up visits for up to ten years. Participants will also be asked to fill out a questionnaire before surgery and again at each follow up visit to help doctors understand how they are doing over time.