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

Sponsor
AstraZeneca
Study ID
NCT05629234
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 8, 2023
Status verified
Apr 2026
Primary completion
Feb 22, 2027
Completion
Feb 22, 2027

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Osimertinib
    Participants will receive Osimertinib

Primary Outcome Measure

Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) [ Time Frame: Until 90 days after the last dose of study treatment ]

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