2024-04-15 - 2033-12-31
Phase III
尚未開始11
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
一項針對患有表皮生長因子受體（EGFR）突變型晚期非鱗狀非小細胞肺癌（NSCLC）且先前接受過EGFR酪胺酸激酶抑制劑治療後惡化的受試者，研究使用MK-2870相較於含鉑雙藥化學治療的隨機分配、開放性第三期試驗
-
試驗申請者
美商默沙東藥廠股份有限公司台灣分公司
-
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
-
臨床試驗規模
多國多中心
-
更新日期
2026/04/24
試驗主持人及試驗醫院
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 尚未開始
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
適應症
試驗目的
藥品名稱
主成份
劑型
劑量
評估指標
主要納入條件
• 您年滿18歲
• 您患有具有特定基因變化（基因體變異）的晚期或轉移性NSCLC
• 您的NSCLC之前已接受過治療，且無法透過手術或化學放射療法進一步治療
大約有520人將參與本試驗。
可能會有一些原因使您無法參加本試驗，試驗醫師或人員將與您討論這些原因。
主要排除條件
Predominantly squamous cell histology NSCLC.
History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
Grade ≥2 peripheral neuropathy.
History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.
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 is allowed.
Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention.
Known active central nervous system metastases and/or carcinomatous meningitis.
Active infection requiring systemic therapy.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Concurrent active HBV and HCV infection.
History of allogeneic tissue/solid organ transplant.
Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
試驗計畫預計收納受試者人數
-
台灣人數
45 人
-
全球人數
520 人
