計劃書編號D6187C00001
試驗執行中
2025-09-22 - 2029-03-18
Phase II
召募中9
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
一項開放性、多藥物、多中心、第II 期試驗之主計畫書，評估新型併用療法用於罹患局部晚期或轉移性非小細胞肺癌參與者中的安全性、耐受性、藥物動力學、免疫原性和抗腫瘤活性(LIBRA)
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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
2026/03/01
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
•安全性: 發生不良事件(AE)和嚴重不良事件(SAE)的受試者數 Number of participants with adverse events (AE) and serious adverse events (SAE)•療效: 評估客觀反應率(Objective response rate , ORR)
試驗目的
•安全性：評估併用新型抗癌藥物的安全性和耐受性，並確定建議劑量
Safety: To assess the safety and tolerability and determine the recommended dose of the combination of novel anti-cancer agents.
•療效：評估客觀反應率(ORR)，藉此評估新型藥物併用其他抗癌藥物的療效
Efficacy: To assess the efficacy of novel agents in combination with other anti-cancer agents by evaluation of ORR .
藥品名稱
注射劑
注射劑
注射劑
注射劑
注射劑
主成份
datopotamab deruxtecan
Rilvegostomig
1013005500
Rilvegostomig
1013005500
劑型
270
270
270
270
270
劑量
NA
NA
10 mg/mL
NA
10 mg/mL
評估指標
•安全性:
發生不良事件(AE)和嚴重不良事件(SAE)的受試者數
Number of participants with adverse events (AE) and serious adverse events (SAE)
•療效:
評估客觀反應率(Objective response rate , ORR)
發生不良事件(AE)和嚴重不良事件(SAE)的受試者數
Number of participants with adverse events (AE) and serious adverse events (SAE)
•療效:
評估客觀反應率(Objective response rate , ORR)
主要納入條件
Inclusion Criteria for All Sub-studies:
- Participant must be ≥ 18 years of age at the time of signing the ICF
- WHO/ECOG performance status of 0 or 1
- At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
- Adequate bone marrow and organ function
- Life expectancy ≥ 12 weeks
- Provision of acceptable tumour tissue
Specific Inclusion Criteria for Sub-Study 1 and Sub-Study 2:
- Histologically or cytologically documented advanced or metastatic NSCLC
- PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)
- Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)
Specific Inclusion Criteria for Sub-Study 3:
- Histologically or cytologically documented advanced or metastatic non-squamous NSCLC
- Documented positive AGA and had progressed on prior targeted therapy
- Participant must be ≥ 18 years of age at the time of signing the ICF
- WHO/ECOG performance status of 0 or 1
- At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
- Adequate bone marrow and organ function
- Life expectancy ≥ 12 weeks
- Provision of acceptable tumour tissue
Specific Inclusion Criteria for Sub-Study 1 and Sub-Study 2:
- Histologically or cytologically documented advanced or metastatic NSCLC
- PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)
- Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)
Specific Inclusion Criteria for Sub-Study 3:
- Histologically or cytologically documented advanced or metastatic non-squamous NSCLC
- Documented positive AGA and had progressed on prior targeted therapy
主要排除條件
Exclusion Criteria for All Sub-studies:-
- As judged by the investigator, any severe or uncontrolled systemic diseases,in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol
- Active or prior documented autoimmune or inflammatory disorders
- Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
- Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3
- Unstable brain metastases
- History of another primary malignancy.
- Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
- Uncontrolled or significant cardiac disease
- Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
- Prior exposure to immune-mediated therapy
- History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
- Any concurrent anti-cancer treatment.
- Receipt of live, attenuated vaccine within 30 days prior to the first dose of
study intervention.
- As judged by the investigator, any severe or uncontrolled systemic diseases,in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol
- Active or prior documented autoimmune or inflammatory disorders
- Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
- Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3
- Unstable brain metastases
- History of another primary malignancy.
- Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
- Uncontrolled or significant cardiac disease
- Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
- Prior exposure to immune-mediated therapy
- History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
- Any concurrent anti-cancer treatment.
- Receipt of live, attenuated vaccine within 30 days prior to the first dose of
study intervention.
試驗計畫預計收納受試者人數
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台灣人數
28 人
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全球人數
278 人
