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Clinical Trials List

Protocol NumberD5161N00007
NCT Number(ClinicalTrials.gov Identfier)NCT05629234
Active

2023-02-01 - 2026-12-31

Phase III

Recruiting6

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/03/01

Investigators and Locations

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳昭勳 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

  • 曹朝榮 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林孟志 Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Min Yeh Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Cancer

Objectives

During the safety and tolerability monitoring period of osimertinib (TAGRISSO), trial treatment will continue to be provided to patients who are determined to have sustained clinical benefit at the end of the clinical trial.

Test Drug

TAGRISSO (泰格莎膜衣錠)

Active Ingredient

osimertinib
osimertinib

Dosage Form

filmcoated tablets

Dosage

40mg
80mg

Endpoints

Notify SAEs and serious AESI until 28 days after last dose of trial treatment

Inclution Criteria

The Core Protocol inclusion criteria are:
1. Provision of signed and dated, written ICF.
2. 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.
3. Females should be using adequate contraceptive measures if of childbearing potential (see protocol Appendix D for definition of adequate contraceptive measures). Male patients should be willing to use barrier contraception, ie, condoms.

There are no additional inclusion criteria for the ROSY-T sub-studyThe Core Protocol exclusion criteria are:
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.
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.
The additional exclusion criteria for the ROSY-T sub-study are:
6. 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.

Exclusion Criteria

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:

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.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    64 participants

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