CancerPhase 3ROSY-TNCT05629234
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T)
A Phase 3 study testing Osimertinib in people with Cancer, run by AstraZeneca at 27 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer
- What is being tested?
- Osimertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 27 sitesin 8 countries
- Study dates
- 8 May 2023to 22 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
27 sites in 8 countries.
27 sites in 8 countries
South Korea9 sites
Research Site
Cheongju-si, 28644
Research Site
Donggu, 44033
Research Site
Goyang-si, 10408
Research Site
Seongnam-si, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06351
Research Site
Seoul, 06591
Research Site
Seoul, 5505
Taiwan6 sites
Research Site
Kaohsiung City, 83301
Research Site
Taichung, 40705
Research Site
Tainan, 704
Research Site
Tainan, 736
Research Site
Taipei, 112201
Research Site
Taoyuan, 333
China4 sites
Research Site
Beijing, 100142
Research Site
Chongqing, 400042
Research Site
Yangzhou, 225001
Research Site
Zhengzhou, 450008
Malaysia4 sites
Research Site
George Town, 10450
Research Site
Johor Bahru, 81100
Research Site
Kuantan, 25100
Research Site
Kuching, 93586
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- Osimertinib
- Keywords
- Cancer, Oncology, Clinically Benefit, Roll Over StudY
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
Also called TAGRISSO
Osimertinib (dose range of 40 mg to 240 mg orally, once daily)
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib | Experimental | Participants will receive Osimertinib Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Safety and tolerability of osimertinib will be assessed.
Measured: Until 90 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start8 May 2023
- Primary completion22 Feb 2027 (estimated)
- Study completion22 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629234
- Sponsor's protocol ID
- D5161N00007
- Acronym
- ROSY-T
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05629234
- Acronym / sponsor ID
- ROSY-T / D5161N00007
- Conditions
- Cancer
- Keywords
- Cancer, Oncology, Clinically Benefit, Roll Over StudY
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 8 May 2023 (actual)
- Primary completion
- 22 Feb 2027 (estimated)
- Study completion
- 22 Feb 2027 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| Osimertinib | Experimental | Drug: OsimertinibParticipants will receive Osimertinib |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsimertinibAlso: TAGRISSOOsimertinib (dose range of 40 mg to 240 mg orally, once daily) | Drug | Osimertinib |
Primary outcome
Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Time frame: Until 90 days after the last dose of study treatment
Safety and tolerability of osimertinib will be assessed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Osimertinib in people with Cancer, run by AstraZeneca at 27 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in South Korea, Taiwan, China, Malaysia, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) (time frame: Until 90 days after the last dose of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.