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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Drug: Osimertinib

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 37
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100142
    • Research Site
  • Chongqing, China, 400042
    • Research Site
  • Shanghai, China, 200433
    • Research Site
  • Yangzhou, China, 225001
    • Research Site
  • Zhengzhou, China, 450008
    • Research Site
• France
  • Villejuif Cedex, France, 94805
    • Research Site
• Korea, Republic of
  • Cheongju-si, Korea, Republic of, 28644
    • Research Site
  • Dong-gu, Korea, Republic of, 44033
    • Research Site
  • Goyang-si, Korea, Republic of, 10408
    • Research Site
  • Seongnam-si, Korea, Republic of, 13620
    • Research Site
  • Seoul, Korea, Republic of, 03722
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Research Site
  • Seoul, Korea, Republic of, 06351
    • Research Site
  • Seoul, Korea, Republic of, 06591
    • Research Site
  • Seoul, Korea, Republic of, 5505
    • Research Site
• Malaysia
  • Georgetown, Malaysia, 10450
    • Research Site
  • Johor Bahru, Malaysia, 81100
    • Research Site
  • Kuantan, Malaysia, 25100
    • Research Site
  • Kuching, Malaysia, 93586
    • Research Site
• Poland
  • Szczecin, Poland, 70-419
    • Research Site
• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Research Site
  • Taichung, Taiwan, 40705
    • Research Site
  • Tainan, Taiwan, 736
    • Research Site
  • Tainan, Taiwan, 704
    • Research Site
  • Taipei, Taiwan, 112201
    • Research Site
  • Taoyuan, Taiwan, 333
    • Research Site
• United Kingdom
  • Nottingham, United Kingdom, NG5 1PB
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of signed and dated, written Informed Consent Form (ICF).
2. 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.
3. Patients should be using adequate contraceptive measures.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osimertinib; Participants will receive Osimertinib	Drug: Osimertinib; Osimertinib (dose range of 40 mg to 240 mg orally, once daily); Other Names: TAGRISSO

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): February 21, 2025
• Study Completion (Estimated): February 21, 2025

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Oncology; Clinically Benefit; Roll Over StudY
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors; Osimertinib
• Other Study ID Numbers: D5161N00007; 2022-001447-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for individual participant data (IPD), but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No