A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC (AmiNA)
2026年8月27日 更新者：Janssen Research & Development, LLC
A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer
The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC).
NSCLC is the most common type of lung cancer.
NSCLC may occur due to mutations (changes) in many genes, including EGFR.
研究概览
研究类型
介入性
注册 (估计的)
68
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
- 姓名：Study Contact
- 电话号码：844-434-4210
- 邮箱：Participate-In-This-Study1@its.jnj.com
学习地点
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Cheng Du Shi、中国、610044
- 招聘中
- Sichuan Cancer Hospital
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Chengdu、中国、610041
- 招聘中
- West China Hospital Sichuan University
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Guangzhou、中国、510060
- 招聘中
- Guangdong Provincial People's Hospital
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Jinan、中国、250117
- 招聘中
- Shandong Cancer Hospital
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Tianjin、中国、300222
- 招聘中
- Tianjin Chest Hospital
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Ontario
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Toronto、Ontario、加拿大、M5G 2C1
- 招聘中
- Princess Margaret Hospital
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Taichung、台湾、40705
- 招聘中
- Taichung Veterans General Hospital
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Tainan、台湾、736
- 招聘中
- Chi Mei Medical Center Liouying Branch
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Taipei、台湾、110
- 招聘中
- Taipei Medical University Hospital
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Zhubei、台湾、302
- 招聘中
- NTU Biomedical Park Hospital
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California
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Duarte、California、美国、91010
- 招聘中
- City of Hope
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Irvine、California、美国、92618
- 招聘中
- City of Hope 1
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Oregon
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Portland、Oregon、美国、97213
- 招聘中
- Providence Cancer Center
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Portland、Oregon、美国、97225
- 招聘中
- Providence Oncology and Hematology Care Clinic Westside
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Alicante、西班牙、03010
- 招聘中
- Hosp. Gral. Univ. Dr. Balmis
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Madrid、西班牙、28007
- 招聘中
- Hosp. Gral. Univ. Gregorio Maranon
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Buk Gu、韩国、41404
- 招聘中
- Kyungpook National University Chilgok Hospital
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Busan、韩国、49241
- 招聘中
- Pusan National University Hospital
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Seoul、韩国、06351
- 招聘中
- Samsung Medical Center
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Seoul、韩国、152-703
- 招聘中
- Korea University Guro Hospital
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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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Participant must have histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) with completely resectable Stage II-IIIB N2 disease
- Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multidisciplinary team evaluation
- Participant must consent to a screening biopsy, if clinically feasible, if no adequate tumor tissue is available for a baseline sample
- Participant may have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s). Prior or concurrent second malignancies must be reviewed and agreed to with the medical monitor
- Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- History of uncontrolled illness
- Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current interstitial lung disease (ILD)/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Suspected or known allergies, hypersensitivity, or intolerance to excipients of: the combination of amivantamab and lazertinib or carboplatin and pemetrexed
- Presence of primary driver mutations (anaplastic lymphoma kinase [ALK], mesenchymal-epithelial transition [MET], human epidermal growth factor receptor 2 [HER2], proto-oncogene tyrosine-protein kinase ROS [ROS1], neurotrophic tyrosine receptor kinase [NTRK], B-Raf proto-oncogene [BRAF], REarranged during transfection [RET], or kirsten rat sarcoma viral oncogene homolog [KRAS]) , besides EGFR Exon 19del or Exon 21 L858R mutations, as determined by local genomic testing
- Prior treatment with any systemic anti-cancer therapy for NSCLC including EGFR-tyrosine kinase inhibitor (TKI) therapy, chemotherapy, biologic therapy, immunotherapy, or any investigational drug
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：非随机化
- 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 |
|---|---|
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实验性的：Cohort 1: Amivantamab plus Lazertinib
Participants will receive amivantamab in combination with lazertinib.
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将管理Amivantamab。
其他名称：
Lazertinib will be administered.
其他名称：
|
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实验性的：Cohort 2: Amivantamab plus Carboplatin and Pemetrexed
Participants will receive amivantamab in combination with carboplatin and pemetrexed.
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将给予培美曲塞。
将施用卡铂。
将管理Amivantamab。
其他名称：
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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 |
|---|---|---|
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Major Pathologic response (MPR)
大体时间：Up to 1 year 8 months
|
MPR is defined as less than or equal to (<= ) 10 percent (%) residual cancer cells in the surgical specimen, per independent centralized pathology review.
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Up to 1 year 8 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pathological Complete Response (pCR)
大体时间：Up to 1 year 8 months
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pCR is defined as absence of any residual cancer cells in the surgical specimen, per independent centralized pathology review.
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Up to 1 year 8 months
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Number of Participants with Pathologic Nodal Downstaging at the Time of Surgery
大体时间：Baseline and up to 1 year 8 months
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Pathologic nodal downstaging is defined as baseline N2 participants becoming N1/node negative N0 or baseline N1 patients becoming N0 at the time of surgery.
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Baseline and up to 1 year 8 months
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Disease Control Rate (DCR)
大体时间：Up to 1 year 8 months
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DCR is defined as the percentage of participants who achieve a radiologic best overall response (BOR) of partial response (PR), complete response (CR), or stable disease (SD) using response evaluation criteria in solid tumors (RECIST) version 1.1.
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Up to 1 year 8 months
|
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Number of Participants with Adverse Events (AEs) by Severity
大体时间：Up to 1 year 8 months
|
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
An AE does not necessarily have a causal relationship with the treatment.
Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event is considered to be treatment-emergent.
TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, to Grade 5= death related to adverse event.
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Up to 1 year 8 months
|
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Number of Participants with Abnormalities in Clinical Laboratory Parameters
大体时间：Up to 1 year 8 months
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Number of participants with abnormalities in clinical laboratory parameters (which includes hematology, coagulation, clinical chemistry, routine urinalysis, serology and pregnancy test) will be reported.
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Up to 1 year 8 months
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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。
调查人员
- 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
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)
2026年7月28日
初级完成 (估计的)
2028年3月2日
研究完成 (估计的)
2028年4月3日
研究注册日期
首次提交
2026年5月8日
首先提交符合 QC 标准的
2026年5月8日
首次发布 (实际的)
2026年5月14日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年8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
- 61186372PANSC2005 (其他标识符：Janssen Research & Development, LLC)
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
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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.