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

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.

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:

• 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.