計劃書編號CA209-77T
試驗執行中
2020-01-01 - 2026-12-31
Phase III
召募中4
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
針對可手術切除之第II-IIIB期非小細胞肺癌參與者，使用前導性化療加Nivolumab相較於前導性化療加安慰劑，接著進行手術切除合併輔助性治療Nivolumab或安慰劑的一項第3期、隨機分配、雙盲試驗
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試驗申請者
台灣必治妥施貴寶股份有限公司
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試驗委託 / 贊助單位名稱
台灣必治妥施貴寶股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/04/01
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
適應症
可手術切除之第II-IIIB期非小細胞肺癌
試驗目的
由盲性獨立中央審查單位(BICR)比較A組參與者(使用nivolumab加鉑類雙重化療的前導性治療，接著使用nivolumab輔助性治療)相較於B組(單用鉑類雙重化療的前導性治療)參與者之無事件存活期(EFS)。
藥品名稱
注射劑
主成份
Nivolumab
Nivolumab
Nivolumab
劑型
Solution for Injection
Solution for Injection
Solution for Injection
劑量
10mg/mL
10mg/mL
10mg/mL
評估指標
由盲性獨立中央審查單位(BICR)比較A組參與者相較於B組參與者之無事件存活期(EFS)
主要納入條件
6.1 Inclusion Criteria
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. tumor biopsies, and other requirements of the study.
2) Type of Participant and Target Disease Characteristics
a) Participants with suspected or histologically confirmed Stage IIA ( 4 cm) to IIIB (T3N2)
NSCLC (per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual
8th Edition22) with disease that is considered resectable
b) No brain metastasis
c) Participant must be deemed eligible for complete resection and must agree to undergo
standard of care surgery for complete resection of NSCLC after neoadjuvant therapy
d) Treatment-naive (no prior systemic anti-cancer treatment)
e) Ability to provide surgical or biopsy tumor tissue for biomarkers (eg, whole exome
sequencing, PD-L1 testing, etc) See Section 9.8.
f) Eastern Cooperative Oncology Group (ECOG) Performance Status 1
3) Age and Reproductive Status
a) Males and Females, 18 years
b) Women of childbearing potential (WOCBP) must have a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours
prior to the start of study treatment.
c) Women must not be breastfeeding
d) WOCBP must agree to follow instructions for method(s) of contraception (Appendix 4) for
the duration of treatment with study treatments and after the last dose of study treatment
(ie, 30 days [duration of ovulatory cycle] plus the time required for the study drug to
undergo approximately 5 half-lives. WOCBP must agree to follow instructions for
method(s) of contraception for 5 months after the last dose of
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. tumor biopsies, and other requirements of the study.
2) Type of Participant and Target Disease Characteristics
a) Participants with suspected or histologically confirmed Stage IIA ( 4 cm) to IIIB (T3N2)
NSCLC (per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual
8th Edition22) with disease that is considered resectable
b) No brain metastasis
c) Participant must be deemed eligible for complete resection and must agree to undergo
standard of care surgery for complete resection of NSCLC after neoadjuvant therapy
d) Treatment-naive (no prior systemic anti-cancer treatment)
e) Ability to provide surgical or biopsy tumor tissue for biomarkers (eg, whole exome
sequencing, PD-L1 testing, etc) See Section 9.8.
f) Eastern Cooperative Oncology Group (ECOG) Performance Status 1
3) Age and Reproductive Status
a) Males and Females, 18 years
b) Women of childbearing potential (WOCBP) must have a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours
prior to the start of study treatment.
c) Women must not be breastfeeding
d) WOCBP must agree to follow instructions for method(s) of contraception (Appendix 4) for
the duration of treatment with study treatments and after the last dose of study treatment
(ie, 30 days [duration of ovulatory cycle] plus the time required for the study drug to
undergo approximately 5 half-lives. WOCBP must agree to follow instructions for
method(s) of contraception for 5 months after the last dose of
試驗計畫預計收納受試者人數
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台灣人數
8 人
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全球人數
452 人
