計劃書編號D5161N00007
NCT Number(ClinicalTrials.gov Identfier)NCT05629234
試驗執行中
2023-02-01 - 2026-12-31
Phase III
召募中6
ICD-10C34.90
未明示側性支氣管或肺惡性腫瘤
ICD-10C34.91
右側支氣管或肺惡性腫瘤
ICD-10C34.92
左側支氣管或肺惡性腫瘤
ICD-10C7A.090
支氣管及肺惡性類癌
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9162.9
支氣管及肺惡性腫瘤
ROSY-T：針對過去完成接受Osimertinib (TAGRISSO)治療的腫瘤試驗案，並經試驗主持人判定於臨床上受益於持續治療病患的轉入試驗
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試驗申請者
百瑞精鼎國際股份有限公司
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試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
非小細胞肺癌
試驗目的
為於osimertinib (TAGRISSO)安全性與耐受性監測期間，經判定在臨床試驗結束時持續獲臨床效益的病患，持續提供試驗治療
藥品名稱
錠劑
主成份
osimertinib
osimertinib
osimertinib
劑型
filmcoated tablets
劑量
40mg
80mg
80mg
評估指標
通報SAE 和嚴重AESI 直到接受最後一劑試驗治療後28 天為止
主要納入條件
Provision of signed and dated, written Informed Consent Form (ICF).
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.
Patients should be using adequate contraceptive measures.
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.
Patients should be using adequate contraceptive measures.
主要排除條件
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.
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.
試驗計畫預計收納受試者人數
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台灣人數
20 人
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全球人數
64 人
