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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Drug: Osimertinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osimertinib<br>Participants will receive Osimertinib | Drug: Osimertinib<br>* Osimertinib (dose range of 40 mg to 240 mg orally, once daily)<br>* Other names: TAGRISSO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Oncology, Clinically Benefit, Roll Over StudY