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针对可手术非小细胞肺癌 (NSCLC) 成年患者的 Cemiplimab 加化疗与 Cemiplimab 加化疗加其他癌症治疗的研究

2026年10月30日 更新者：Regeneron Pharmaceuticals

一项随机 2 期平台研究，用于评估 Cemiplimab 加化疗与 Cemiplimab 加化疗加其他癌症治疗对可切除非小细胞肺癌患者围手术期治疗的影响

This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer (NSCLC) for whom surgery is planned, in the resectable NSCLC portion.

The aim of the resectable NSCLC portion is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.

For each investigational arm, the available data will be reviewed to decide whether safety testing with chemotherapy is needed before moving the treatment combination to the main resectable NSCLC portion of the study. If safety testing with chemotherapy is required, adult participants whose tumour has spread to other organs or cannot be removed by surgery, will be enrolled in the unresectable/metastatic NSCLC portion of the study called the "safety lead-in."

The aim of the unresectable/metastatic NSCLC safety lead-in portion is to evaluate the safety of the combination of Cemiplimab, chemotherapy, and an additional drug in participants with unresectable or metastatic NSCLC.

For the resectable NSCLC portion, the study is also looking at several other research questions, including:

  • What are the side effects associated with the investigational treatments in comparison to the control treatment
  • Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed
  • How much of the study drug(s) are in the blood at a given time
  • Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)

For the unresectable/metastatic NSCLC portion, the study is also looking at several other research questions, including:

  • What are the side effects associated with the additional drug in combination with cemiplimab and chemotherapy
  • How does the additional drug work in combination with cemiplimab and chemotherapy

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (估计的)

184

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。

学习地点

  • 土耳其（türkiye）
      • Istanbul、土耳其（türkiye）、34295
        • Florya Medical Park Hospital
  • 巴西
      • São Paulo、巴西、01323-903
        • Hospital Alemao Oswaldo Cruz
    • Espírito Santo
      • Cachoeiro de Itapemirim、Espírito Santo、巴西、29306014
        • Oncology Clinical Research Center
    • Minas Gerais
      • Belo Horizonte、Minas Gerais、巴西、30380-472
        • Instituto Mario Penna
      • Pouso Alegre、Minas Gerais、巴西、37554-238
        • Instituto Sul Mineiro De Oncologia LTDA
    • Pernambuco
      • Recife、Pernambuco、巴西、50070-902
        • Instituto de Medicina Integral Professor Fernando Figueira
    • Rio Grande do Norte
      • Natal、Rio Grande do Norte、巴西、59060-195
        • Liga Norte Riograndense Contra o Cancer
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90610-000
        • Hospital Sao Lucas da PUCRS
      • Porto Alegre、Rio Grande do Sul、巴西、90110-270
        • Hospital Mae de Deus Integrated Oncology Center
    • Santa Catarina
      • Florianópolis、Santa Catarina、巴西、88020-210
        • Ynova Pesquisa Clinica
    • São Paulo
      • Sorocaba、São Paulo、巴西、18065-100
        • Unimed Sorocaba
      • São José do Rio Preto、São Paulo、巴西、15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • 德国
      • Aachen、德国、52074
        • University Hospital RWTH Aachen
    • Hesse
      • Kassel、Hesse、德国、34125
        • Klinikum Kassel GmbH, Hauttumorzentrum
    • Lower Saxony
      • Göttingen、Lower Saxony、德国、37083
        • University Medicine Gottingen
    • Saxony
      • Leipzig、Saxony、德国、04103
        • University of Leipzig
  • 法国
      • Bayonne、法国、64100
        • Clinique Belharra
      • Bayonne、法国、64100
        • Centre Hospitalier de la Cote Basque
      • Grenoble、法国、38330
        • CHU Grenoble Alpes
      • Montpellier、法国、34295
        • Montpellier Academic Hospital
    • Brittany Region
      • Rennes、Brittany Region、法国、35033
        • CHU Rennes
    • Var
      • Toulon、Var、法国、83055
        • Centre Hospitalier Intercommunal Toulon - CHITS
    • Île-de-France Region
      • Paris、Île-de-France Region、法国、75005
        • Institut Curie
  • 美国
    • California
      • Orange、California、美国、92868
        • University of California Irvine
    • Illinois
      • Skokie、Illinois、美国、60077
        • Orchard Healthcare Research Inc.
    • Michigan
      • Detroit、Michigan、美国、48201
        • Karmanos Cancer Institute
      • Farmington Hills、Michigan、美国、48334
        • Detroit Clinical Research Center
    • Ohio
      • Cincinnati、Ohio、美国、45245
        • Oncology Hematology Care Clinical Trials LLC
    • Oregon
      • Portland、Oregon、美国、97213
        • Providence Portland Medical Center
      • Portland、Oregon、美国、97213
        • University Of Nebraska Medical Center
    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • Lifespan Cancer Institute
    • South Dakota
      • Watertown、South Dakota、美国、57201
        • Prairie Lakes Healthcare System
    • Tennessee
      • Knoxville、Tennessee、美国、37920
        • University of Tennessee Medical Center
      • Nashville、Tennessee、美国、37203
        • Sarah Cannon Research Institute (SCRI) Oncology Partners
    • Virginia
      • Blacksburg、Virginia、美国、24060
        • BRCC/Oncology & Hematology Associates of SW Virginia
  • 西班牙
      • Madrid、西班牙、28046
        • Hospital Universitario La Paz
      • Madrid、西班牙、28040
        • Hospital Universitario Clinico San Carlos
      • Madrid、西班牙、28033
        • MD Anderson Cancer Center
      • Madrid、西班牙、28050
        • Hospital Universitario HM Sanchinarro
      • Seville、西班牙、41013
        • Hospital Virgen del Rocio
      • Valencia、西班牙、46014
        • Consorci Hospital General Universitario de Valencia
      • Valencia、西班牙、46010
        • Hospital Clinico Universitario Valencia
      • Zaragoza、西班牙、50009
        • Hospital Clinico Lozano Blesa
    • Barcelona
      • Badalona、Barcelona、西班牙、08916
        • Catalan Instituye of Oncology Badalona
    • Cantabria
      • Santander、Cantabria、西班牙、39008
        • Hospital Valdecilla
    • Las Palmas
      • Las Palmas de Gran Canaria、Las Palmas、西班牙、35016
        • Hospital Universitario Insular de Gran Canaria
    • Navarre
      • Pamplona、Navarre、西班牙、31008
        • Clinica Universidad de Navarra

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

Neoadjuvant Resectable NSCLC General Key Inclusion Criteria:

  1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
  2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
  3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
  4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
  5. Adequate organ and bone marrow function, as described in the protocol

Arm Specific Inclusion Criteria:

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:

  1. Non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic disease), who received no prior systemic treatment for recurrent or metastatic NSCLC
  2. Availability of an archival or on-trial FFPE tumor tissue sample
  3. ECOG performance status of 0 or 1
  4. Per investigator judgment, life expectancy of at least 3 months

Neoadjuvant Resectable NSCLC General Key Exclusion Criteria:

  1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
  2. Presence of actionable oncogenic alterations in the tumor for which an approved targeted therapy is available or for which perioperative chemoimmunotherapy is not considered an appropriate standard of care treatment, as described in the protocol
  3. Presence of grade≥ 2 peripheral neuropathy
  4. Another malignancy that is progressing or requires active treatment, as described in the protocol

Arm Specific Exclusion Criteria:

Neoadjuvant Resectable NSCLC - Arm 1:

  1. Grade ≥3 hypercalcemia, as defined in the protocol
  2. Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
  3. Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:

  1. Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
  2. Presence of actionable oncogenic alterations in the tumor for which a chemotherapy plus programmed cell death protein 1 (PD1) inhibitor backbone is not the appropriate initial therapy as standard of care
  3. Known allergy or hypersensitivity to any components of trial interventions
  4. Any condition requiring ongoing/continuous corticosteroid therapy, as described in the protocol

Neoadjuvant Resectable NSCLC - Arm 2:

1. History of encephalitis, meningitis, organic brain disease, or uncontrolled seizures within 1 year prior to the first dose of trial interventions.

Note: Other protocol-defined Inclusion/Exclusion criteria apply.

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Neoadjuvant Resectable NSCLC - Control Arm
药品：Cemiplimab

Administered per the protocol

其他名称：
  • REGN2810
  • 利比塔约
药品：Platinum-based chemotherapy

Administered per the protocol
实验性的：Neoadjuvant Resectable NSCLC - Arm 1
药品：Marlotamig

Administered per the protocol

其他名称：
  • REGN7075
药品：Cemiplimab

Administered per the protocol

其他名称：
  • REGN2810
  • 利比塔约
药品：Platinum-based chemotherapy

Administered per the protocol
实验性的：Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
药品：Cemiplimab

Administered per the protocol

其他名称：
  • REGN2810
  • 利比塔约
药品：Platinum-based chemotherapy

Administered per the protocol

药品：REGN10597

Administered per the protocol

其他名称：
  • PD-1-IL2Ra-IL2 immunotherapy
实验性的：Neoadjuvant Resectable NSCLC - Arm 2
药品：Cemiplimab

Administered per the protocol

其他名称：
  • REGN2810
  • 利比塔约
药品：Platinum-based chemotherapy

Administered per the protocol

药品：REGN10597

Administered per the protocol

其他名称：
  • PD-1-IL2Ra-IL2 immunotherapy

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
Major Pathologic Response (MPR) rate as determined by central Blinded Independent Pathology Review (BIPR)
大体时间：Up to 12 weeks
Up to 12 weeks
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
大体时间：Up to 9 weeks

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
Up to 9 weeks
Occurrence of TEAEs leading to death
大体时间：Up to 9 weeks

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
Up to 9 weeks
Occurrence of TEAEs leading to treatment discontinuation
大体时间：Up to 9 weeks

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
Up to 9 weeks
Occurrence of Serious Adverse Events (SAEs)
大体时间：Up to 9 weeks

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
Up to 9 weeks
Occurrence of grade ≥3 laboratory abnormalities
大体时间：Up to 9 weeks

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2

As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades)
Up to 9 weeks
Number of participants unable to receive cemiplimab and chemotherapy for 2 consecutive cycles due to REGN10597-related toxicities during the first 3 cycles
大体时间：Up to 9 weeks

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
Up to 9 weeks

次要结果测量

结果测量
措施说明
大体时间
总生存期（OS）
大体时间：长达 5 年
长达 5 年
TEAE 的严重程度
大体时间：长达 76 周
长达 76 周
因 TEAE 导致延迟手术的比例
大体时间：长达 76 周
长达 76 周
因 TEAE 而取消手术的比例
大体时间：长达 76 周
长达 76 周
Pathologic Complete Response (pCR) rate as determined by central BIPR
大体时间：Up to 12 weeks
Up to 12 weeks
Residual Viable Tumor (RVT) as determined by central BIPR
大体时间：Up to 12 weeks
Up to 12 weeks
Event-Free Survival (EFS)
大体时间：Up to 5 years
Up to 5 years
Objective Response by investigator assessment
大体时间：Up to 9 weeks
Up to 9 weeks
Duration of Response (DoR) by investigator assessment
大体时间：Up to 2 years

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
Up to 2 years
Occurrence of TEAEs
大体时间：Up to 76 weeks
Up to 76 weeks
Occurrence of TEAEs leading to death
大体时间：Up to 76 weeks
Up to 76 weeks
Occurrence of TEAEs leading to treatment discontinuation
大体时间：Up to 76 weeks
Up to 76 weeks
Occurrence of SAEs
大体时间：Up to 76 weeks
Up to 76 weeks
Severity of SAEs
大体时间：Up to 76 weeks
Up to 76 weeks
Occurrence of Adverse Events of Special Interest (AESIs)
大体时间：Up to 76 weeks
Up to 76 weeks
Severity of AESIs
大体时间：Up to 76 weeks
Up to 76 weeks
Occurrence of immune-mediated Adverse Events (imAEs)
大体时间：Up to 76 weeks
Up to 76 weeks
Severity of imAEs
大体时间：Up to 76 weeks
Up to 76 weeks
Occurrence of Infusion-Related Reactions (IRRs)
大体时间：Up to 76 weeks
Up to 76 weeks
Severity of IRRs
大体时间：Up to 76 weeks
Up to 76 weeks
Occurrence of grade ≥3 laboratory abnormalities
大体时间：Up to 76 weeks

As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades)
Up to 76 weeks
Occurrence of Anti-Drug Antibodies (ADAs) to cemiplimab
大体时间：Up to 67 weeks
Up to 67 weeks
Magnitude of ADAs to cemiplimab
大体时间：Up to 67 weeks
Up to 67 weeks
Occurrence of ADAs to marlotamig
大体时间：Up to 67 weeks
Up to 67 weeks
Magnitude of ADAs to marlotamig
大体时间：Up to 67 weeks
Up to 67 weeks
Occurrence of ADAs to REGN10597
大体时间：Up to 67 weeks
Up to 67 weeks
Magnitude of ADAs to REGN10597
大体时间：Up to 67 weeks
Up to 67 weeks

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

Regeneron Pharmaceuticals

调查人员

  • 研究主任：Clinical Trial Management、Regeneron Pharmaceuticals

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)

2024年11月18日

初级完成 (估计的)

2029年12月4日

研究完成 (估计的)

2034年12月27日

研究注册日期

首次提交

2024年6月13日

首先提交符合 QC 标准的

2024年6月13日

首次发布 (实际的)

2024年6月18日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月30日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • R2810-ONC-2268
  • 2023 (美国 NIH 拨款/合同)
  • 2023-509806-31-00 (克蒂斯)

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

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD 共享时间框架

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD 共享访问标准

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

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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