計劃書編號MK-2870-007
NCT Number(ClinicalTrials.gov Identfier)NCT06170788
2023-12-01 - 2031-05-31
Phase III
召募中8
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
一項針對患有轉移性非小細胞肺癌且PD-L1 TPS大於或等於50%的受試者，研究以MK-2870併用Pembrolizumab相較於Pembrolizumab單一療法用於第一線治療之隨機分配、開放性第三期試驗
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試驗申請者
美商默沙東藥廠股份有限公司台灣分公司
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試驗委託 / 贊助單位名稱
美商默沙東藥廠股份有限公司台灣分公司
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臨床試驗規模
多國多中心
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更新日期
2025/08/20
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
非小細胞肺癌
試驗目的
- 測試MK-2870 和pembro 併用的安全性
- 觀察接受MK-2870 和pembro 的受試者是否比單獨接受pembro 的受試者活得更久
- 觀察MK-2870 和pembro 相較於單獨使用pembro 的效果如何
- 觀察接受MK-2870 和pembro 的受試者是否比單獨接受pembro 的受試者擁有更好的生活品質
藥品名稱
MK-2870
Keytruda Injection
Keytruda Injection
主成份
Recombinant humanized IgG1 anti-TROP2 monoclonal antibody conjugated to KL610023
Pembrolizumab
Pembrolizumab
劑型
Injection
Injection
Injection
劑量
200 mg/20 mL
25 mg/mL
25 mg/mL
評估指標
整體存活期(OS)
主要納入條件
如果您符合以下條件，就可以參加本試驗：
• 您已年滿18歲。
• 患有已擴散到您身體其他部位的非小細胞肺癌且尚未接受過治療。
• 您的腫瘤組織也必須對一種稱為程序性細胞死亡配體1（PD-L1）的生物標記檢測為陽性。生物標記是一種生物學特徵。不同的腫瘤可能會有不同的生物標記。試驗醫師將就此與您討論。
將使用一項檢測來了解您的檢體是否具有這些特徵。研究已顯示這項檢測通常是準確的，但無法保證結果。有可能檢測會呈現偽陰性（檢體具有生物標記，但是檢測結果表示沒有）或偽陽性（檢體沒有生物標記，但是檢測結果表示有）。如果是偽陰性，將不會允許您參加本試驗，即使您可能從試驗治療得到益處。如果是偽陽性，您可能參加試驗，但是可能不會從試驗治療得到益處。如果您符合以下條件，就可以參加本試驗：
• 您已年滿18歲。
• 患有已擴散到您身體其他部位的非小細胞肺癌且尚未接受過治療。
• 您的腫瘤組織也必須對一種稱為程序性細胞死亡配體1（PD-L1）的生物標記檢測為陽性。生物標記是一種生物學特徵。不同的腫瘤可能會有不同的生物標記。試驗醫師將就此與您討論。
將使用一項檢測來了解您的檢體是否具有這些特徵。研究已顯示這項檢測通常是準確的，但無法保證結果。有可能檢測會呈現偽陰性（檢體具有生物標記，但是檢測結果表示沒有）或偽陽性（檢體沒有生物標記，但是檢測結果表示有）。如果是偽陰性，將不會允許您參加本試驗，即使您可能從試驗治療得到益處。如果是偽陽性，您可能參加試驗，但是可能不會從試驗治療得到益處。
• 您已年滿18歲。
• 患有已擴散到您身體其他部位的非小細胞肺癌且尚未接受過治療。
• 您的腫瘤組織也必須對一種稱為程序性細胞死亡配體1（PD-L1）的生物標記檢測為陽性。生物標記是一種生物學特徵。不同的腫瘤可能會有不同的生物標記。試驗醫師將就此與您討論。
將使用一項檢測來了解您的檢體是否具有這些特徵。研究已顯示這項檢測通常是準確的，但無法保證結果。有可能檢測會呈現偽陰性（檢體具有生物標記，但是檢測結果表示沒有）或偽陽性（檢體沒有生物標記，但是檢測結果表示有）。如果是偽陰性，將不會允許您參加本試驗，即使您可能從試驗治療得到益處。如果是偽陽性，您可能參加試驗，但是可能不會從試驗治療得到益處。如果您符合以下條件，就可以參加本試驗：
• 您已年滿18歲。
• 患有已擴散到您身體其他部位的非小細胞肺癌且尚未接受過治療。
• 您的腫瘤組織也必須對一種稱為程序性細胞死亡配體1（PD-L1）的生物標記檢測為陽性。生物標記是一種生物學特徵。不同的腫瘤可能會有不同的生物標記。試驗醫師將就此與您討論。
將使用一項檢測來了解您的檢體是否具有這些特徵。研究已顯示這項檢測通常是準確的，但無法保證結果。有可能檢測會呈現偽陰性（檢體具有生物標記，但是檢測結果表示沒有）或偽陽性（檢體沒有生物標記，但是檢測結果表示有）。如果是偽陰性，將不會允許您參加本試驗，即使您可能從試驗治療得到益處。如果是偽陽性，您可能參加試驗，但是可能不會從試驗治療得到益處。
主要排除條件
Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
Has Grade ≥2 peripheral neuropathy.
History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
Received prior systemic anticancer therapy for their metastatic NSCLC.
Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.
Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.
Active autoimmune disease that has required systemic treatment in the past 2 years.
History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
Active infection requiring systemic therapy
Concurrent active Hepatitis B and Hepatitis C virus infection.
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
History of allogeneic tissue/solid organ transplant.
Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.
Has Grade ≥2 peripheral neuropathy.
History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
Received prior systemic anticancer therapy for their metastatic NSCLC.
Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.
Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.
Active autoimmune disease that has required systemic treatment in the past 2 years.
History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
Active infection requiring systemic therapy
Concurrent active Hepatitis B and Hepatitis C virus infection.
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
History of allogeneic tissue/solid organ transplant.
Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.
試驗計畫預計收納受試者人數
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台灣人數
18 人
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全球人數
614 人
