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Clinical Trials in the UK / NCT05629234
Active, not recruiting Phase 3

Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T)

NCT05629234 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2023-05-08
Last updated
2026-07-09

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

Osimertinib

Osimertinib: Osimertinib (dose range of 40 mg to 240 mg orally, once daily)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: 1. Provision of signed and dated, written Informed Consent Form (ICF). 2. 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. 3. Patients should be using adequate contraceptive measures. Exclusion Criteria: 1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study. 2. Currently receiving treatment with any prohibited medication(s). 3. Concurrently enrolled in any other type of medical research judged not to be scientifically, or medically compatible with this study. 4. Permanent discontinuation from the parent study due to toxicity or disease progression. 5. Local access to commercially-available drug at no cost to the patient is permitted by local regulation. Exclusion Criteria for the sub-study: 1\. 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 * CD4+ count of \> 350 cells/μL * No history of AIDS-defining opportunistic infection within the past 12 months (to be determined by hepatologist) post treatment * Stable for at least 4 weeks on anti-HIV medications.

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
Research Site Beijing China
Research Site Chongqing China
Research Site Yangzhou China
Research Site Zhengzhou China
Research Site Villejuif France
Research Site Kashiwa Japan
Research Site George Town Malaysia
Research Site Johor Bahru Malaysia
Research Site Kuantan Malaysia
Research Site Kuching Malaysia
Research Site Szczecin Poland
Research Site Cheongju-si South Korea
Research Site Goyang-si South Korea
Research Site Seongnam-si South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Tonggu South Korea
Research Site Kaohsiung City Taiwan
Research Site Taichung Taiwan
Research Site Tainan Taiwan
Research Site Tainan Taiwan
Research Site Taipei Taiwan
Research Site Taoyuan Taiwan
Research Site Nottingham United Kingdom

On this site

📄 Tagrisso (osimertinib) drug profile →

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05629234 on ClinicalTrials.gov ↗ ← All trials in the UK