Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T)
ROSY-T
ROSY-T: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
1 other identifier
interventional
37
7 countries
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 cancer
Started May 2023
Typical duration for phase_3 cancer
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2022
CompletedFirst Posted
Study publicly available on registry
November 29, 2022
CompletedStudy Start
First participant enrolled
May 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 22, 2027
December 24, 2025
December 1, 2025
3.8 years
November 17, 2022
December 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Safety and tolerability of osimertinib will be assessed.
Until 90 days after the last dose of study treatment
Study Arms (1)
Osimertinib
EXPERIMENTALParticipants will receive Osimertinib
Interventions
Osimertinib (dose range of 40 mg to 240 mg orally, once daily)
Eligibility Criteria
You may qualify if:
- Provision of signed and dated, written Informed Consent Form (ICF).
- Patient is currently deriving clinical benefit from continued treatment with osimertinib in an AstraZeneca parent study using osimertinib monotherapy which has met its endpoints or has otherwise stopped.
- Patients should be using adequate contraceptive measures.
You may not qualify if:
- Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
- Currently receiving treatment with any prohibited medication(s).
- Concurrently enrolled in any other type of medical research judged not to be scientifically, or medically compatible with this study.
- Permanent discontinuation from the parent study due to toxicity or disease progression.
- Local access to commercially-available drug at no cost to the patient is permitted by local regulation.
- \. Active infection including active hepatitis C and Human immunodeficiency virus (HIV) infection or active uncontrolled Hepatitis B virus (HBV) infection. Screening for chronic conditions is not required.
- Patients with HBV infection are only eligible if they meet all the following criteria:
- Demonstrated absence of HCV co-infection or history of HCV co-infection;
- Demonstrated absence of HIV infection;
- Patients receiving anti-viral treatment for at least 6 weeks prior to study treatment, HBV DNA is suppressed to \< 100 IU/mL, and transaminase levels are below ULN.
- Patients with a resolved or chronic HBV infection are eligible if they are:
- Negative for HBsAg and positive for anti-HBc IgG. In addition, patients must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study treatment and 6 to 12 months (to be determined by hepatologist) post treatment; or
- Positive for HBsAg, but for \> 6 months have had transaminases levels below ULN and HBV DNA levels below \< 100 IU/mL (ie, patients are in an inactive carrier state). In addition, patients must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study treatment.
- Should participants with HIV infection be included, patients are only eligible if they meet all the following criteria:
- Undetectable viral RNA load for 6 months
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (26)
Research Site
Beijing, 100142, China
Research Site
Chongqing, 400042, China
Research Site
Yangzhou, 225001, China
Research Site
Zhengzhou, 450008, China
Research Site
Villejuif, 94805, France
Research Site
George Town, 10450, Malaysia
Research Site
Johor Bahru, 81100, Malaysia
Research Site
Kuantan, 25100, Malaysia
Research Site
Kuching, 93586, Malaysia
Research Site
Szczecin, 70-419, Poland
Research Site
Cheongju-si, 28644, South Korea
Research Site
Donggu, 44033, South Korea
Research Site
Goyang-si, 10408, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 5505, South Korea
Research Site
Kaohsiung City, 83301, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Tainan, 704, Taiwan
Research Site
Tainan, 736, Taiwan
Research Site
Taipei, 112201, Taiwan
Research Site
Taoyuan District, 333, Taiwan
Research Site
Nottingham, NG5 1PB, United Kingdom
MeSH Terms
Conditions
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2022
First Posted
November 29, 2022
Study Start
May 8, 2023
Primary Completion (Estimated)
February 22, 2027
Study Completion (Estimated)
February 22, 2027
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for individual participant data (IPD), but this does not mean all requests will be shared.