2020-04-01 - 2025-11-26
Phase III
尚未開始2
召募中4
終止收納1
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
一項針對先前未經治療的局部晚期非小細胞肺癌病患，比較Nivolumab 併用同步化放療後使用Nivolumab 加 Ipilimumab 或Nivolumab 併用同步化放療後使用Nivolumab，相較於同步化放療後使用Durvalumab 之第三期、隨機分配、開放性試驗
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試驗申請者
台灣必治妥施貴寶股份有限公司
-
試驗委託 / 贊助單位名稱
台灣必治妥施貴寶股份有限公司
-
臨床試驗規模
多國多中心
-
更新日期
2026/04/01
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 尚未開始
實際收案人數
0 尚未開始
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
試驗目的
藥品名稱
主成份
Nivolumab
Ipilimumab
Ipilimumab
劑型
注射劑
注射液劑
注射液劑
劑量
10mg/ml
5mg/ml
5mg/ml
評估指標
主要納入條件
6.1.1 Inclusion Criteria for CCRT
1) Signed Written Informed Consent
a) Participants must have signed and dated an IRB/IEC approved written informed consent
form in accordance with regulatory and institutional guidelines. This must be obtained
before the performance of any protocol related procedures that are not part of normal
participant care
b) Participants must be willing and able to comply with scheduled visits, treatment schedule,
and laboratory testing
2) Participant and Target Disease Characteristics
a) ECOG performance status ?1 (See Appendix 5)
b) Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0)
histologically-confirmed NSCLC, according to 8th TNM classification36, that is amenable
to definitive CCRT. Participants who are not planned for potential curative surgical
resection are eligible.
i) Overt cT4 disease, including encasement of the large vessels defined by ＞ 50 % of the
circumference OR
ii) Nodal status N2 or N3 must be proven (by biopsy in at least one N2 or N3 node, via
EBUS, mediastinoscopy or thoracoscopy) OR
iii) Nodal status N1 must be proven (by biopsy in at least one N1 node, via EBUS,
mediastinoscopy or thoracoscopy) for T3 disease
c) Newly diagnosed and treatment-naive, with no prior local or systemic anticancer therapy
given as primary therapy for locally advanced disease
d) Measurable disease per RECIST 1.1 criteria
e) All participants must have tissue submitted to a central laboratory during screening. Either
a formalin-fixed, paraffin-embedded (FFPE) tissue block or a minimum of 15 unstained
tumor tissue sections, obtained within 3 months prior to enrollment, with an associated
pathology report, must be submitted to the central laboratory for inclusion. If less than 15
slides are available, BMS must be contacted to discuss the inclusion of the patient. Biopsy
should be excisional, core needle or surgical specimen. Fine needle aspiration is
unaccepta
試驗計畫預計收納受試者人數
-
台灣人數
6 人
-
全球人數
1400 人
