ROSY-T: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Osimertinib (TAGRISSO) and are Judged by the Investigator to Clinically Benefit From Continued Treatment

Phase 1

Recruiting

• Conditions: Various tumor types depending on the parent study; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-501528-58-00
• Lead Sponsor: Astrazeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Provision of signed and dated, written ICF., Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment with osimertinib (TAGRISSO) in an AstraZeneca parent study using osimertinib (TAGRISSO) monotherapy, which has met its endpoints or has otherwise stopped., Females should be using adequate contraceptive measures if of childbearing potential. Male patients should be willing to use barrier contraception, ie, condoms.

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. Note: In countries where, according to local requirements, it is not possible to switch patients to the commercial drug through prescription, even if fully reimbursed, patients are eligible to participate in the ROSY-T sub-study., Active infection (eg, patients receiving treatment for infection) including active hepatitis C and HIV infection or active uncontrolled 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 and 6 to 12 months (to be determined by hepatologist) post treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified