2023-11-01 - 2035-12-31
Phase III
召募中7
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
一項第3期、隨機分配、雙盲、安慰劑和活性對照藥物對照的臨床試驗，針對已切除之第II、IIIA、IIIB（N2）期非小細胞肺癌的受試者，研究使用輔助性V940（mRNA-4157）加Pembrolizumab相較於輔助性安慰劑加Pembrolizumab (INTerpath-002)
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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
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
實際收案人數
0 召募中
適應症
試驗目的
藥品名稱
注射劑
主成份
Pembrolizumab
劑型
Injection
劑量
25 mg/mL
評估指標
主要納入條件
您的癌症必須已在手術過程中被完全切除，並在手術後接受化學治療。
您必須能夠提供來自您NSCLC切除手術中的組織檢體以及血液檢體。這些檢體將會被檢測以了解其是否符合試驗要求以製作V940個人化治療。若您已經在限定篩選期期間提供組織檢體且符合試驗要求，則無需提供更多來自手術的檢體。
•您的組織檢體也可能用於改善和開發檢測（例如：分析方法驗證和生物標記鑑定）以幫助癌症患者。此組織可能會被完全使用而無法用於未來的檢測。
•您的醫師或試驗醫師可以提供您更多有關這些檢測的資訊，且會讓您知道您的檢體是否符合試驗要求。
•提供這些檢體進行檢測並不能保證您將參與本試驗。
•如果您能參與本試驗，提供這些檢體不表示您將接受V940。
可能有其他原因使您無法參與本試驗，試驗醫師或人員將與您討論這些原因。
大約有868人將參與本試驗。
主要排除條件
The main exclusion criteria include but are not limited to the following:
Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Received prior neoadjuvant therapy for their current NSCLC diagnosis.
Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
Known additional malignancy that is progressing or has required active treatment within the past 5 years.
Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Active infection requiring systemic therapy.
試驗計畫預計收納受試者人數
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台灣人數
36 人
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全球人數
868 人
