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子研究 01I：针对既往接受过治疗的 IV 期鳞状非小细胞肺癌 (NSCLC) 参与者的研究药物研究 (MK-3475-01I/KEYMAKER-U01I)

2026年11月10日 更新者：Merck Sharp & Dohme LLC

KEYMAKER-U01 子研究 01I：一项 2 期、随机、伞式研究，对既往接受过治疗的 IV 期鳞状非小细胞肺癌 (NSCLC) 受试者进行研究药物的滚臂研究

Researchers are looking for other ways to treat metastatic squamous non-small cell lung cancer (NSCLC). Squamous NSCLC is cancer that starts in squamous cells, which are flat cells that line the inside of the airways in the lungs. Metastatic means the cancer has spread to other parts of the body.

Standard treatment (usual treatment) for metastatic squamous NSCLC is immunotherapy with or without chemotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. However, standard treatment may not work or may stop working to treat metastatic squamous NSCLC.

Researchers want to learn if study treatments that are antibody drug conjugates (ADCs) can treat metastatic squamous NSCLC that did not respond (get smaller or go away) to standard treatment. An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.

The main goals of this study are to learn about:

  • The cancer response to the study treatments compared to chemotherapy
  • The safety of the study treatments and if people tolerate them

This study is one of the substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798

研究类型

介入性

注册 (估计的)

144

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
        • 招聘中
        • Beijing Cancer Hospital ( Site 0301)
        • 接触：
          • Study Coordinator
          • 电话号码：010-88121122
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、400030
        • 招聘中
        • Chongqing University Cancer Hospital ( Site 0304)
        • 接触：
          • Study Coordinator
          • 电话号码：+86023-65311341
    • Fujian
      • Fuzhou、Fujian、中国、350014
        • 招聘中
        • Fujian Provincial Cancer Hospital ( Site 0310)
        • 接触：
          • Study Coordinator
          • 电话号码：0591-83660063
    • Guangxi
      • Nanning、Guangxi、中国、530201
        • 招聘中
        • Guangxi Medical University Cancer Hospital ( Site 0303)
        • 接触：
          • Study Coordinator
          • 电话号码：0771-5323175
    • Henan
      • Zhengzhou、Henan、中国、450000
        • 招聘中
        • Henan Cancer Hospital ( Site 0311)
        • 接触：
          • Study Coordinator
          • 电话号码：+8613837174273
    • Jiangsu
      • Nanjing、Jiangsu、中国、210008
        • 招聘中
        • Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309)
        • 接触：
          • Study Coordinator
          • 电话号码：+86021-65115006
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200433
        • 招聘中
        • Shanghai Pulmonary Hospital ( Site 0300)
        • 接触：
          • Study Coordinator
          • 电话号码：021-65115006
      • Shanghai、Shanghai Municipality、中国、200030
        • 招聘中
        • Shanghai Chest Hospital ( Site 0308)
        • 接触：
          • Study Coordinator
          • 电话号码：021-63846590
  • 以色列
      • Haifa、以色列、3109601
        • 招聘中
        • Rambam Health Care Campus ( Site 0076)
        • 接触：
          • Study Coordinator
          • 电话号码：+972 47776234
      • Jerusalem、以色列、9103102
        • 招聘中
        • Shaare Zedek Medical Center ( Site 0075)
        • 接触：
          • Study Coordinator
          • 电话号码：+972-2-6555768
      • Kfar Saba、以色列、4428164
        • 招聘中
        • Meir Medical Center ( Site 0071)
        • 接触：
          • Study Coordinator
          • 电话号码：+97297472414
      • Petah Tikva、以色列、4941492
        • 招聘中
        • Rabin Medical Center ( Site 0074)
        • 接触：
          • Study Coordinator
          • 电话号码：+97239378101
      • Ramat Gan、以色列、5265601
        • 招聘中
        • Sheba Medical Center ( Site 0070)
        • 接触：
          • Study Coordinator
          • 电话号码：+97235307032
      • Tel Aviv、以色列、6423906
        • 招聘中
        • Sourasky Medical Center ( Site 0077)
        • 接触：
          • Study Coordinator
          • 电话号码：+972-3-6973082
  • 匈牙利
    • Bács-Kiskun county
      • Kecskemét、Bács-Kiskun county、匈牙利、6000
        • 招聘中
        • Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)
        • 接触：
          • Study Coordinator
          • 电话号码：+3676516700
    • Győr-Moson-Sopron
      • Győr、Győr-Moson-Sopron、匈牙利、9024
        • 招聘中
        • Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)
        • 接触：
          • Study Coordinator
          • 电话号码：+3696507900
    • Jász-Nagykun-Szolnok
      • Szolnok、Jász-Nagykun-Szolnok、匈牙利、5000
        • 招聘中
        • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)
        • 接触：
          • Study Coordinator
          • 电话号码：+3656503603
  • 土耳其（türkiye）
      • Adana、土耳其（türkiye）、01250
        • 招聘中
        • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)
        • 接触：
          • Study Coordinator
          • 电话号码：+905353067506
      • Ankara、土耳其（türkiye）、06230
        • 招聘中
        • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)
        • 接触：
          • Study Coordinator
          • 电话号码：+90 312 305 43 36
      • Ankara、土耳其（türkiye）、06800
        • 招聘中
        • Ankara Bilkent Şehir Hastanesi. ( Site 0142)
        • 接触：
          • Study Coordinator
          • 电话号码：+903125529999
      • Istanbul、土耳其（türkiye）、34098
        • 招聘中
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0144)
        • 接触：
          • Study Coordinator
          • 电话号码：+902124143000
    • İzmir
      • Izmir、İzmir、土耳其（türkiye）、35100
        • 招聘中
        • Ege Universitesi Hastanesi ( Site 0143)
        • 接触：
          • Study Coordinator
          • 电话号码：+90 232 343 43 43
  • 希腊
      • Thessaloniki、希腊、570 01
        • 招聘中
        • European Interbalkan Medical Center-Oncology Department ( Site 0205)
        • 接触：
          • Study Coordinator
          • 电话号码：0030 2310400213
    • Attica
      • Athens、Attica、希腊、115 27
        • 招聘中
        • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204)
        • 接触：
          • Study Coordinator
          • 电话号码：0030 2107700220
      • Athens、Attica、希腊、116 34
        • 招聘中
        • F. THERAPIS GENERAL ( Site 0206)
        • 接触：
          • Study Coordinator
          • 电话号码：+302107291111
  • 德国
      • Berlin、德国、13353
        • 招聘中
        • Charite-Universitaetsmedizin Berlin ( Site 0191)
        • 接触：
          • Study Coordinator
          • 电话号码：+49 30 450 553 044
    • Baden-Wurttemberg
      • Tübingen、Baden-Wurttemberg、德国、72076
        • 招聘中
        • UniversitaetsklInikum Tuebingen ( Site 0192)
        • 接触：
          • Study Coordinator
          • 电话号码：+4970712982795
  • 意大利
      • Florence、意大利、50134
        • 招聘中
        • Azienda Ospedaliera Universitaria Careggi ( Site 0173)
        • 接触：
          • Study Coordinator
          • 电话号码：+393209225506
      • Milan、意大利、20132
        • 招聘中
        • IRCCS Ospedale San Raffaele ( Site 0171)
        • 接触：
          • Study Coordinator
          • 电话号码：+390223903829
      • Milan、意大利、20133
        • 招聘中
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
        • 接触：
          • Study Coordinator
          • 电话号码：390223902190
      • Roma、意大利、00168
        • 招聘中
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
        • 接触：
          • Study Coordinator
          • 电话号码：+390630156318
  • 智利
    • Region M. de Santiago
      • Santiago、Region M. de Santiago、智利、7500653
        • 招聘中
        • Centro de Estudios Clínicos SAGA ( Site 0161)
        • 接触：
          • Study Coordinator
          • 电话号码：+56991612199
      • Santiago、Region M. de Santiago、智利、8420383
        • 招聘中
        • Bradfordhill ( Site 0162)
        • 接触：
          • Study Coordinator
          • 电话号码：+56229490970
      • Santiago、Region M. de Santiago、智利、7500921
        • 招聘中
        • Fundación Arturo López Pérez ( Site 0160)
        • 接触：
          • Study Coordinator
          • 电话号码：56227128000
  • 波兰
    • Greater Poland Voivodeship
      • Poznan、Greater Poland Voivodeship、波兰、60-569
        • 招聘中
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)
        • 接触：
          • Study Coordinator
          • 电话号码：+48616654242
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰、02-781
        • 招聘中
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)
        • 接触：
          • Study Coordinator
          • 电话号码：+48225463066
    • Pomeranian Voivodeship
      • Gdansk、Pomeranian Voivodeship、波兰、80-214
        • 招聘中
        • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
        • 接触：
          • Study Coordinator
          • 电话号码：+48585844466
    • West Pomeranian Voivodeship
      • Koszalin、West Pomeranian Voivodeship、波兰、75-581
        • 招聘中
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)
        • 接触：
          • Study Coordinator
          • 电话号码：+48943488930
  • 美国
    • Kentucky
      • Lexington、Kentucky、美国、40536-0293
        • 招聘中
        • University of Kentucky Chandler Medical Center ( Site 0019)
        • 接触：
          • Study Coordinator
          • 电话号码：859-257-1000
    • Maryland
      • Baltimore、Maryland、美国、21237
        • 招聘中
        • MedStar Franklin Square Medical Center ( Site 0033)
        • 接触：
          • Study Coordinator
          • 电话号码：443-777-7147
    • Texas
      • Dallas、Texas、美国、75246-2046
        • 招聘中
        • Texas Oncology - DFW ( Site 8003)
        • 接触：
          • Study Coordinator
          • 电话号码：214-370-1067
    • Virginia
      • Fairfax、Virginia、美国、22031
        • 招聘中
        • Virginia Cancer Specialists (VCS) ( Site 0408)
        • 接触：
          • Study Coordinator
          • 电话号码：703-280-5390
  • 西班牙
      • Madrid、西班牙、28223
        • 招聘中
        • Hospital Universitario Quiron Madrid ( Site 0091)
        • 接触：
          • Study Coordinator
          • 电话号码：34914521987
      • Seville、西班牙、41009
        • 招聘中
        • Hospital Universitario Virgen Macarena ( Site 0094)
        • 接触：
          • Study Coordinator
          • 电话号码：+34 671560092
    • Barcelona
      • L'Hospitalet de Llobregat、Barcelona、西班牙、08908
        • 招聘中
        • Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
        • 接触：
          • Study Coordinator
          • 电话号码：0034932607744
    • Catalonia
      • Barcelona、Catalonia、西班牙、08036
        • 招聘中
        • Hospital Clinic de Barcelona ( Site 0092)
        • 接触：
          • Study Coordinator
          • 电话号码：34 932275402

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)
  • Has documented disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1), as assessed by investigator after receiving an anti-programmed cell death protein 1 (anti-PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy for Stage IV disease
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
  • Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
  • Has uncontrolled or significant cardiovascular disorder
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), or prior pneumonectomy
  • Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
  • Has clinically significant corneal disease
  • Has previously received docetaxel as monotherapy or in combination with other therapies
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Evidence of any leptomeningeal disease
  • Has one or more of the following indicators of interstitial lung disease (ILD)/pneumonitis: any history of ILD/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), current diagnosis of ILD, clinical or radiographic suspicion of ILD
  • Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
  • Active infection requiring systemic therapy
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • Known history of, or active, neurologic paraneoplastic syndrome
  • History of allogeneic tissue/solid organ transplant
  • Has not adequately recovered from major surgery or have ongoing surgical complications

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm 1: Raludotatug deruxtecan (R-DXD)

Participants receive 5.6 mg/kg of R-DXD, every 3 weeks (Q3W) (Day 1 of every 21-day cycle) via intravenous (IV) infusion until progressive disease (PD) or discontinuation.
生物：R-DXD

IV Infusion

其他名称：
  • DS-6000a
  • 德鲁多塔格德鲁斯特坎
  • MK-5909
药品：Rescue Medications

Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines.
实验性的：Arm 3: I-DXD Low Dose

Participants receive 8 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.
药品：Rescue Medications

Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines.

生物：I-DXD

IV Infusion

其他名称：
  • DS-7300a
  • MK-2400
  • 伊非那单抗
有源比较器：Arm 4: Docetaxel

Participants receive 75 mg/m^2 of Docetaxel, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.
药品：Docetaxel

IV Infusion

其他名称：
  • 泰索帝®
药品：Rescue Medication

Participants are premedicated with corticosteroids per approved product label and following institutional standards or local guidelines.
实验性的：Arm 2: Ifinatamab deruxtecan (I-DXD) High Dose

Participants receive 12 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.
药品：Rescue Medications

Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines.

生物：I-DXD

IV Infusion

其他名称：
  • DS-7300a
  • MK-2400
  • 伊非那单抗

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Objective Response Rate (ORR)
大体时间：Up to approximately 81 months

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) as assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR will be assessed by Blinded Independent Central Review (BICR). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 81 months
Number of participants who experience one or more adverse events (AEs)
大体时间：Up to approximately 81 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Up to approximately 81 months
Number of participants who discontinue study intervention due to an AE
大体时间：Up to approximately 81 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 81 months

次要结果测量

结果测量
措施说明
大体时间
Duration of Response (DOR)
大体时间：Up to approximately 81 months

For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Up to approximately 81 months
Progression-free Survival (PFS)
大体时间：Up to approximately 81 months

PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Up to approximately 81 months
Overall Survival (OS)
大体时间：Up to approximately 81 months

OS is defined as time from randomization to death due to any cause.
Up to approximately 81 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Merck Sharp & Dohme LLC

合作者

Daiichi Sankyo

调查人员

  • 研究主任：Medical Director、Merck Sharp & Dohme LLC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年5月28日

初级完成 (估计的)

2032年3月2日

研究完成 (估计的)

2032年3月2日

研究注册日期

首次提交

2025年1月13日

首先提交符合 QC 标准的

2025年1月13日

首次发布 (实际的)

2025年1月17日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 3475-01I
  • MK-3475-01I (其他标识符：MSD)
  • U1111-1314-2392 (注册表标识符：UTN)
  • KEYMAKER-01I (其他标识符：MSD)
  • 2024-518839-11-00 (注册表标识符：EU CT)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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