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

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.