計劃書編號MK-2870-004
NCT Number(ClinicalTrials.gov Identfier)NCT06074588
試驗執行中
2023-11-15 - 2031-12-31
Phase III
尚未開始9
召募中3
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
一項針對先前接受過治療且帶有EGFR突變或其他基因體變異的晚期或轉移性非鱗狀非小細胞肺癌（NSCLC），研究使用MK-2870相較於化學治療（Docetaxel或Pemetrexed）的隨機分配、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
2026/02/01
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
非小細胞肺癌
試驗目的
主要目的
•針對帶有EGFR突變的NSCLC，由盲性獨立中央審查（BICR）根據實體腫瘤反應評估標準第1.1版（RECIST 1.1）評估，比較MK-2870與化學治療之無惡化存活期（PFS）。
•針對帶有EGFR突變的NSCLC，比較MK-2870與化學治療之整體存活期（OS）。
次要目的
•針對所有患有NSCLC的受試者，由BICR根據RECIST 1.1評估，比較MK-2870與化學治療之PFS。
•針對所有患有NSCLC的受試者，比較MK-2870與化學治療之OS。
•由BICR依據RECIST 1.1，針對帶有EGFR突變的NSCLC，比較MK-2870與化學治療之客觀反應率（ORR）。
•由BICR依據RECIST 1.1，針對所有患有NSCLC的受試者，比較MK-2870與化學治療之ORR。
•針對帶有EGFR突變的NSCLC以及所有患有NSCLC的受試者，評估MK-2870相較於化學治療之反應持續時間（DOR）。
•針對帶有EGFR突變的NSCLC以及所有患有NSCLC的受試者，評估MK-2870相較於化學治療之整體健康狀態／生活品質（QoL）、呼吸困難、咳嗽和胸痛從基期以來的平均變化。
•針對帶有EGFR突變的NSCLC以及所有患有NSCLC的受試者，對於MK-2870相較於化學治療以整體健康狀態／QoL、呼吸困難、咳嗽和胸痛評估至惡化前所經時間。
•評估MK-2870的安全性和耐受性。
藥品名稱
靜脈輸注液
靜脈輸注液
靜脈輸注液
靜脈輸注液
靜脈輸注液
主成份
MK-2870
Pemetrexed
Docetaxel
Pemetrexed
Docetaxel
劑型
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
劑量
200 mg/vial
500 mg/vial
20 mg/mL
500 mg/vial
20 mg/mL
評估指標
- 無惡化存活期（PFS）：從隨機分配至首次記錄疾病惡化或任何原因而死亡的時間，以先發生者為準。
- 整體存活期（OS）：從隨機分配至任何原因而死亡的時間。
- 整體存活期（OS）：從隨機分配至任何原因而死亡的時間。
主要納入條件
Inclusion Criteria:
Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
Measurable disease per RECIST 1.1 as assessed by the local site investigator.
Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
Have an ECOG performance status of 0 or 1 within 3 days before randomization.
Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
Measurable disease per RECIST 1.1 as assessed by the local site investigator.
Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
Have an ECOG performance status of 0 or 1 within 3 days before randomization.
主要排除條件
Exclusion Criteria:
Has predominantly squamous cell histology NSCLC.
Has mixed tumor(s) with small cell elements.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
Has Grade ≥2 peripheral neuropathy.
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention.
Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
Received prior treatment with a topoisomerase I-containing ADC.
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
Active infection requiring systemic therapy.
History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks, and are off steroids 3 days prior to dosing with study medication.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
Has predominantly squamous cell histology NSCLC.
Has mixed tumor(s) with small cell elements.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
Has Grade ≥2 peripheral neuropathy.
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention.
Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
Received prior treatment with a topoisomerase I-containing ADC.
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
Active infection requiring systemic therapy.
History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks, and are off steroids 3 days prior to dosing with study medication.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
試驗計畫預計收納受試者人數
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台灣人數
35 人
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全球人數
556 人
