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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05629234

Acronym

ROSY-T

Enrollment

Registered

2022-11-29

Start date

2023-05-08

Completion date

2027-02-22

Last updated

2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer, Oncology, Clinically Benefit, Roll Over StudY

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.

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.

Interventions

DRUGOsimertinib

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

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Sequential Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)	Until 90 days after the last dose of study treatment	Safety and tolerability of osimertinib will be assessed.

Countries

China, France, Japan, Malaysia, Poland, South Korea, Taiwan, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026