ROSY-T
Research type
Research Study
Full title
ROSY-T: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Osimertinib (TAGRISSO) and are Judged by the Investigator to Clinically Benefit From Continued Treatment
IRAS ID
1006512
Contact name
Agathe Cabarrot
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-501528-58
Research summary
The purpose of this study is to ensure participants continue to receive osimertinib (TAGRISSO) for the treatment of their cancer (at no cost) and to monitor its safety and tolerability. This is the same study drug that participants have received (and continue to receive) when they recently took part in a study with osimertinib (TAGRISSO).
Osimertinib (TAGRISSO) has received marketing authorisation in 92 countries for the treatment of patients with locally advanced or metastatic non-small cell lung cancer and for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumour’s have mutations.
This study is about providing continued treatment with osimertinib (TAGRISSO) for participants who were previously benefiting from treatment. The study doctor will decide if participants should continue to receive osimertinib (TAGRISSO) or not. For this reason, the number of participants taking part in this study is not defined.
Participants will be eligible to stay in the study for as long as they are getting benefit from osimertinib (TAGRISSO) and do not meet any discontinuation criteria.
Osimertinib (TAGRISSO) will be administered orally (taken by mouth) and has to be taken once daily. The dose of each tablet will be decided by their study doctor (1 to 3 tablets a day in total depending on the dose).
Participants will have study visits approximately every 12 weeks. At each visit the participant will receive sufficient osimertinib (TAGRISSO) tablets for the next 12 weeks.
There are no study specific procedures or tests that will be completed during the study. The study doctor will conduct routine safety assessments and evaluations to make sure participants are tolerating treatment with osimertinib (TAGRISSO) and to monitor their disease.
Approximately 32 sites worldwide will participate in this study.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
23/EE/0128
Date of REC Opinion
12 Sep 2023
REC opinion
Further Information Favourable Opinion