The rationale of the ROSY-T study is to continue to provide study treatment for patients who have participated in a parent study with osimertinib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.
ROSY-T is an open label, non-randomised, multicentre, international trial for patients who have completed a parent study using osimertinib and who are deriving clinical benefit from continued treatment as judged by the Investigator. Patients will be rolled-over from the parent study and will continue the study, until they meet one of the treatment discontinuation criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Osimertinib (dose range of 40 mg to 240 mg orally, once daily)
Research Site
Beijing, China
Research Site
Chongqing, China
Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Safety and tolerability of osimertinib will be assessed.
Time frame: Until 90 days after the last dose of study treatment
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Research Site
Yangzhou, China
Research Site
Zhengzhou, China
Research Site
Villejuif, France
Research Site
George Town, Malaysia
Research Site
Johor Bahru, Malaysia
Research Site
Kuantan, Malaysia
Research Site
Kuching, Malaysia
Research Site
Szczecin, Poland
...and 16 more locations