An Open-label, Single-arm, Multicenter Phase II Study to Evaluate the Efficacy of Amivantamab in Combination With FOLFIRI as a Second-line Treatment in Patients With RAS/BRAF Wild-type Advanced Colorectal Cancer Progressing on Prior Anti-EGFR Based Treatment.

This trial is a multicenter, single arm study of efficacy of amivantamab in combination with FOLFIRI in RAS/BRAF wild-type advanced colorectal cancer patients progressed prior treatment including oxaliplatin based chemotherapy. This trial will be conducted by Severance Hospital that is responsible for the project management of the trial. Patient recruitment will take at 3 institutions.
Participants will be treated for up to 24 cycles (approximately 2 years) after initiation of treatment with intravenous 1050mg(BW<80kg) or 1400mg(BW≥80kg) of amivantamab every 4 weeks in combination with FOLFIRI. FOLFIRI includes folic acid, 5-FU and irinotecan. FOLFIRI will be administered intravenously with folic acid 400 mg/m², 5-FU 2400 mg/m², and irinotecan 180 mg/m² every 2 weeks. This study will use ORR based on RECIST 1.1 criteria as the primary endpoint and the tumor assessment will be done every 8 weeks. Secondary endpoints are DCR, PFS, OS, and safeties. Exploratory biomarkers in tumor tissue and ctDNA in blood will be investigated in both pre-treatment and post-treatment periods.

开始日期2025-05-01

申办/合作机构

Yonsei University

CTR20251076

/ Recruiting临床1/2期

一项在复发性/转移性头颈部鳞状细胞癌受试者中评价Amivantamab单药治疗和Amivantamab联合标准治疗药物的开放性Ib/II期研究

本研究的目的是在复发性/转移性头颈癌受试者中确定Amivantamab单药治疗、Amivantamab联合帕博利珠单抗、Amivantamab联合紫杉醇以及Amivantamab联合帕博利珠单抗和卡铂的安全性和初步疗效。该研究还将确认Amivantamab联合紫杉醇的推荐II期联合剂量(RP2CD)。

开始日期2025-04-24

申办/合作机构

强生（中国）投资有限公司

[+4]

ChiCTR2500100101

/ Suspended临床2期IIT

Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Standard of Care Therapeutic Agents in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

开始日期2025-04-14

申办/合作机构

上海市东方医院

100 项与埃万妥单抗相关的临床结果

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100 项与埃万妥单抗相关的转化医学

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100 项与埃万妥单抗相关的专利（医药）

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194

项与埃万妥单抗相关的文献（医药）

2025-12-01·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

作者: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

2025-08-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Evolving treatment for advanced non-small cell lung cancer harbouring common EGFR activating mutations

Review

作者: Califano, Raffaele ; Bria, Emilio ; Gomez-Randulfe, Igor ; Monaca, Federico ; Planchard, David

A clinically important subgroup of non-small cell lung cancer (NSCLC) is driven by common mutations in the epidermal growth factor receptor (EGFR). Over the past decade, first-, second-, and third-generation EGFR tyrosine kinase inhibitors (TKIs) have substantially improved clinical outcomes, although acquired resistance inevitably emerges. In particular, the third-generation TKI osimertinib has demonstrated superior progression-free survival (PFS) and overall survival (OS) compared to earlier-generation TKIs in the frontline setting, yet median OS remains approximately three years in pivotal trials. Efforts to extend disease control have led to various upfront intensification strategies, including combining EGFR TKIs with antiangiogenics or chemotherapy (e.g., the FLAURA-2 trial), and pairing novel bispecific antibodies such as amivantamab with third-generation TKIs. Upon progression on third-generation EGFR TKIs, platinum-based chemotherapy remains the standard second-line treatment, albeit with modest response rates. Emerging therapies targeting MET amplification (e.g., savolitinib plus osimertinib), leveraging antibody-drug conjugates (e.g., patritumab deruxtecan), or adding immunotherapy and antiangiogenics have shown preliminary promise in overcoming resistance. Ongoing trials are assessing optimal treatment sequencing and the use of circulating tumor DNA (ctDNA) to guide therapy escalation or de-escalation. Ultimately, the evolving landscape of EGFR-mutant NSCLC underscores the need for refined biomarker-driven approaches and personalized regimens to achieve further gains in survival. In this review, we discuss these strategies in detail, highlighting current evidence and future directions for EGFR-mutant NSCLC treatment.

2025-07-01·Respiratory Investigation

Current treatment landscape for patients with non–small cell lung cancer with common EGFR mutations

Review

作者: Hayashi, Hidetoshi ; Miyata, Masayuki

Common EGFR mutations including exon-19 deletions and the L858R point mutation in exon 21 constitute predominant actionable genomic alterations in individuals with non-small cell lung cancer (NSCLC). The introduction of EGFR tyrosine kinase inhibitors (TKIs) has fundamentally changed the treatment landscape for such patients by improving both progression-free survival (PFS) and overall survival (OS). Among EGFR-TKIs, third-generation agents such as osimertinib have shown marked efficacy and favorable safety profiles and have become the standard of care in the first-line setting. The combination of osimertinib with platinum-based chemotherapy has recently been shown to improve PFS compared with osimertinib monotherapy in the FLAURA2 trial. Similarly, the MARIPOSA trial demonstrated clinical benefit of the combination of the EGFR-MET bispecific antibody, amivantamab, with the third-generation EGFR-TKI, lazertinib, further supporting the use of combination therapies as first-line treatment for EGFR-mutated NSCLC. Despite these advances, however, challenges such as brain metastases remain substantial barriers to successful treatment outcomes. Management of patients with such metastases often requires a multidisciplinary approach that integrates systemic treatment with local interventions such as radiation therapy. Finally, circulating tumor DNA has emerged as a promising biomarker for real-time monitoring of treatment response and evolution of drug resistance mechanisms. Analysis of such biomarkers can facilitate dynamic and personalized therapeutic adjustments, potentially improving outcomes. This review provides a comprehensive overview of the latest clinical evidence supporting therapeutic advances in the management of EGFR-mutated NSCLC, emphasizing the importance of tailoring treatment strategies based on tumor biology, patient-specific factors, and evolving therapeutic options.

720

项与埃万妥单抗相关的新闻（医药）

2025-05-28

·药研网

c-MET靶点再掀巨浪，ADC破局而来?

阅读导览前言经典靶点c-MET简介c-MET 研发历程c-MET 在研药物总结与展望前言5月14日，艾伯维c-Met ADC药物Emrelis（telisotuzumab vedotin）获FDA加速批准上市，用于c-Met高表达NSCLC二线治疗（首个该靶点ADC获批），成为全球首个c-MET靶点ADC。随着Emrelis的上市，这个曾在小分子和双抗领域打拼多年的“老靶点”，正通过ADC技术实现惊艳“再出圈”。经典靶点c-MET简介c-Met（间充质-上皮转化因子）与RON同属于MET家族，是一种受体酪氨酸激酶，表达于多种上皮细胞表面，其配体为肝细胞生长因子（HGF）。HGF/c-MET轴在胚胎发育、组织修复及细胞迁移中发挥重要生理作用，但一旦异常激活，将成为强力的致癌驱动通路。 c-MET在多种实体瘤中频繁异常激活，包括基因扩增、外显子14跳跃突变（METex14 skipping）、蛋白过度表达或激活性点突变等方式，从而触发PI3K/AKT、RAS/MAPK、STAT3等多条下游信号通路，推动肿瘤的增殖、转移、抗药性以及免疫逃逸。c-MET的异常活化被认为与多种肿瘤发生密切相关，包括非小细胞肺癌、胃癌、肝癌、结直肠癌等。图示：c-Met 的结构以及 c-Met 单克隆抗体和小分子抑制剂的结合位点c-MET 研发历程回顾c-MET靶点的研发历程，其发展大致经历了三轮“浪潮”。第一轮是以小分子抑制剂为代表的早期尝试，如诺华的Capmatinib、默克的Tepotinib和阿斯利康/和黄医药合作的Savolitinib，主要用于治疗MET突变型NSCLC。尽管起步较早，疗效明确，但因突变比例有限、疗效窗口狭窄，其后续发展面临挑战。第二轮则由双抗技术推动，以强生推出的EGFR/c-MET双抗Amivantamab为标志，不再依赖基因突变筛选，通过双靶点协同阻断显著提升治疗获益，将一线治疗疾病进展风险降低 30%，尽管当前年销售额仅8亿美元，但在去年12月5日的投资者日上，强生公司放出一个重磅炸弹：其核心产品之一的Amivantamab（埃万妥单抗）在肺部疾病组合的销售峰值为50亿美元，在一线的市占率剑指50%，根据此优异数据可知，EGFR/c-MET双靶点药物有望成为NSCLC治疗领域的重磅产品。经历多年发展，ADC技术正式加入c-MET治疗“大乱斗”，推动c-MET靶点重回肿瘤研发热点，带来了第三轮“浪潮”。2024年，艾伯维推出基于telisotuzumab vedotin的ADC药物Emrelis，首次将ADC技术成功引入c-MET高表达肿瘤治疗领域。在II期临床中，Emrelis取得了34.6%的客观缓解率（ORR）和14.6个月的中位总生存期（OS），充分展现了ADC技术在c-MET治疗上的独特优势。艾伯维还在积极推进其新一代c-MET ADC——ABBV-400（携带拓扑异构酶I抑制剂TOP1i载荷）。该药在2024年ESMO大会上公布的I期临床数据显示，在接受过标准治疗失败的EGFR野生型非鳞状NSCLC患者中，ABBV-400展现出更强“战斗力”：ORR达到48%，中位无进展生存期（mPFS）为6.9个月。尤其令人瞩目的是，在c-MET高表达人群中，ABBV-400的ORR进一步飙升至77.8%，中表达人群也达到60%，显示出高度分层精准治疗的潜力。如果后续数据稳中有进，ABBV-400不仅有望巩固艾伯维在c-MET ADC领域的领先地位，更可能实现“FIC之后再造me-better”的典范之举，完成一场自我革命。吉满生物推出c-MET功能细胞系、表达细胞系、抗体、蛋白等产品和服务，充分满足药物研发需求，助力药物临床申报。详情咨询吉满客服联系同微信：18916119826！c-MET 在研药物如今，c-MET靶点正再次成为肿瘤治疗研发的热点赛道。据不完全统计，全球已有超过200项围绕c-MET的在研项目，涵盖小分子、单抗、双抗、三抗、ADC乃至双抗ADC等不同技术路径，赛道参与者既有强生、诺华、阿斯利康等传统药企，也有百济神州、宜联生物、嘉和生物、先声再明等创新型Biotech积极入局。数据来源：新药情报库国内方面，宜联生物将其c-MET ADC管线授权罗氏，恒瑞医药开发了HER3/c-MET双抗ADC和c-MET ADC SHR-1826，嘉和生物则在全球率先布局EGFR/c-MET/c-MET三抗，百济神州也在积极推进三抗平台。以SHR-1826为例，该药由c-MET单抗与小分子偶联而成，在多种肿瘤模型中展现出显著抑制效果和良好安全性，代表了下一代精准c-MET治疗的新方向。恒瑞医药SHR-1826SHR-1826 是一款 c-MET ADC，由人源化 c-MET 靶向 IgG2 单克隆抗体通过基于四肽的可裂解连接体连接至拓扑异构酶 I 抑制剂有效载荷组成。SHR-1826可以与肿瘤细胞表面的靶抗原特异性结合，被内吞进入肿瘤细胞后杀伤肿瘤细胞。体内实验显示，SHR-1826对人肺癌、胃癌、结直肠癌下移植瘤模型生长具有较强的抑制作用，有旁路杀伤效应。临床前研究显示，SHR-1826可以显著抑制c-Met表达肿瘤细胞的增殖，安全性良好。5月27日，恒瑞在2025年ASCO大会上首次公布 SHR-1826 用于晚期恶性实体瘤的 I 期临床试验（NCT06094556）结果。该研究招募了携带MET变异（过表达、扩增或突变）的晚期实体瘤患者，剂量范围2.2-6.0 mg/kg，三周一次，累计116例患者接受治疗。58名非小细胞肺癌（NSCLC）患者中，客观缓解率（ORR）为39.7%，疾病控制率（DCR）达94.8%。中位无进展生存期（PFS）为6.8个月。缓解效果在不同c-MET表达及EGFR状态患者中均有体现。安全性良好，3级及以上不良事件主要为血细胞减少，少数患者出现间质性肺炎，无治疗相关死亡。研究表明，SHR-1826在MET变异的晚期实体瘤患者中具有良好抗肿瘤活性和可控安全性，值得进一步临床开发。研究者得出结论，SHR-1826 在接受过大量治疗的晚期实体瘤患者中表现出可控的安全性。在 MET 突变的 NSCLC 中观察到了良好的抗癌活性，值得在该人群中进一步研究。图源：2025 ASCO官网总结从最初的小分子抑制剂，到多功能抗体，再到精确打击的ADC技术，c-MET靶点的命运一次次随着技术的革新而焕发新生。据Evaluate Pharma预测，c-Met ADC全球峰值销售额可达30亿美元，更验证了其自主研发能力。正如HER2因ADC而获得适应症的重大拓展，c-MET也正从“突变靶点”走向“表达靶点”甚至“泛瘤种靶点”。在技术驱动、内卷之下，一场新变局也正在加速到来。吉满生物吉满生物推出c-MET功能细胞系、表达细胞系、抗体、蛋白等产品和服务，充分满足药物研发需求，助力药物临床申报。(咨询吉满客服联系同微信：18916119826）。产品列表数据展示GM-C19962：H_cMET CHO-K1 Cell Line使用Anti-H_HGFR(Met) hIgG4 Antibody流式验证结果GM-C21328：Cynomolgus_cMET CHO-K1 Cell Line使用Anti-H_HGFR(Met) hIgG4 Antibody流式验证结果GM-C38145：H_cMET:cMET Dimerization U2OS Cell Line使用Anti-H_HGFR(Met) hIgG4 Antibody(Emibetuzumab)抗体block验证结果使用Recombinant Human HGF稳定性验证结果使用Anti-H_HGFR(Met) hIgG4 Antibody(Emibetuzumab)抗体流式稳定性验证结果GM-87764RP：Human HGFR(Met) Protein; His TagELISA验证联系我们吉满生物(Genomeditech)成立于2011年，是专业从事生物科技服务和前沿技术研发的高新技术企业。吉满生物专注为生物药开发赋能，自主创立了国内知名的细胞系品牌-DDXCELL，目前已布局近400个热门靶向药靶点，超1000株现货单克隆细胞系，涵盖GPCR、细胞因子、免疫检查点、TAA等多领域，做到进口细胞的国产替代。此外，吉满生物还可在药物研发进程中提供一系列抗体、蛋白产品，旨在为客户提供高效的研发工具和解决方案!扫码咨询扫码找现货参考资料【1】https://molecular-cancer-biomedcentral-com.libproxy1.nus.edu.sg/articles/10.1186/s12943-018-0796-y【2】https://doi-org.libproxy1.nus.edu.sg/10.1158/1535-7163.MCT-16-0472【3】https://www.asco.org/annual-meeting

抗体药物偶联物上市批准临床结果临床2期

2025-05-28

·肿瘤界

2025 ASCO | 10余项中国研究入选！肺癌口头报告摘要标题一文速览

点击蓝字关注我们前言作为肿瘤学领域的国际盛会，ASCO年会每年都吸引着来自世界各地的顶尖学者、临床专家与科研团队，共同分享最新研究成果、探讨创新疗法、展望未来趋势。随着2025年ASCO年会完整日程的正式公布，全球肿瘤学界的目光再次聚焦于此。在此，本文特整理了本届ASCO大会中肺癌领域入选的Oral Abstract Session（口头报告专场）、Rapid Oral Abstract Session（快速口头报告专场）以及Clinical Science Symposium（临床科学研讨会）的研究，让我们先一睹为快！Oral Abstract Session口头报告专场摘要号：2004研究英文名称：A phase II study of asandeutertinib (TY-9591) in advanced NSCLC patients with EGFR-positive mutations and brain metastases.研究中文名称：asandeutertinib（TY-9591）在EGFR阳性突变和脑转移的晚期NSCLC患者中的II期研究讲者：邢力刚 | 中国医学科学院肿瘤医院摘要号：3001研究英文名称：Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with driver genomic alterations (GA) outside of classic EGFR mutations.研究中文名称：BL-B01D1（iza-bren）治疗携带经典EGFR突变以外驱动基因改变的局部晚期或转移性NSCLC的I期临床研究：一种靶向EGFR×HER3的双特异特异性抗体驱动药物偶联物（ADC）的评估讲者：杨云鹏 | 中山大学肿瘤防治中心摘要号：3002研究英文名称：Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic small cell lung cancer (SCLC).研究中文名称：iza-bren（BL-B01D1），一种EGFR x HER3双特异性ADC，在局部晚期或转移性小细胞肺癌（SCLC）患者中的I期研究讲者：黄岩 | 中山大学肿瘤防治中心摘要号：LBA8000研究英文名称：Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816.研究中文名称：CheckMate 816研究中可切除NSCLC患者新辅助纳武利尤单抗联合化疗的总生存期分析讲者：Patrick M. Forde | Trinity St. James's Cancer Institute, Trinity College Dublin摘要号：8001研究英文名称：Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.研究中文名称：NeoADAURA研究：可切除EGFR突变NSCLC术前新辅助奥希替尼±化疗对比单纯化疗讲者：Jamie E. Chaft | Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY; Department of Medicine, Weill Cornell Medical College摘要号：8002研究英文名称：Lung cancer diagnosis rates (LCDR) in lung cancer screening (LCS) and incidental pulmonary nodule (IPN) cohorts in the Mississippi Delta.研究中文名称：密西西比三角洲地区肺癌筛查与偶然发现肺结节队列中的肺癌诊断率研究讲者：Raymond U. Osarogiagbon | Baptist Cancer Center, Multidisciplinary Thoracic Oncology Program摘要号：8003研究英文名称：SWOG/NRG S1914: Randomized phase III trial of induction/consolidation atezolizumab + SBRT versus SBRT alone in high risk, early-stage NSCLC.研究中文名称：SWOG/NRG S1914研究：高危早期NSCLC诱导/巩固期阿替利珠单抗联合SBRT对比单纯SBRT的随机III期试验讲者：Megan Eileen Daly | Department of Radiation Oncology, University of California Davis Comprehensive Cancer Center摘要号：LBA8004研究英文名称：R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy.研究中文名称：R-ALPS研究：贝莫苏拜单抗（TQB2450）联合或不联合安罗替尼维持治疗经同步或序贯放化疗后无进展的局部晚期不可切除（III期）NSCLC患者的随机、双盲、安慰剂对照、多中心III期临床试验讲者：陈明 | 中山大学肿瘤防治中心摘要号：LBA8005研究英文名称：Randomized phase II trial investigating whether atezolizumab after chemoradiotherapy (CRT) prolongs survival in limited stage (LS) small cell lung cancer (SCLC).研究中文名称：局限期小细胞肺癌（LS-SCLC）化放疗后使用阿替利珠单抗是否延长生存的随机II期试验讲者：Bjorn Henning Gronberg | Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology and Department of Oncology, St. Olavs Hospital摘要号：8006研究英文名称：Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial.研究中文名称：III期IMforte研究：芦比替定联合阿替利珠单抗作为广泛期小细胞肺癌（ES‑SCLC）患者一线维持治疗的主要结果讲者：Luis G. Paz-Ares | Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc摘要号：8007研究英文名称：A phase 2 dose expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced small cell lung cancer.研究中文名称：ZG006（一种靶向CD3/DLL3/DLL3的三特异性T细胞接合器）单药治疗晚期SCLC的II期剂量扩展研究讲者：艾星浩 | 上海交通大学医学院附属胸科医院摘要号：LBA8008研究英文名称：Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of Ph3 DeLLphi-304.研究中文名称：Tarlatamab对比化疗（CTx）二线（2L）治疗SCLC：III期DeLLphi-304研究的主要分析讲者：Charles M Rudin | Fiona and Stanley Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center摘要号：8500研究英文名称：First-line adagrasib (ADA) with pembrolizumab (PEMBRO) in patients (pts) with advanced/metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) from the phase 2 portion of the KRYSTAL-7 study.研究中文名称：II期KRYSTAL‑7研究：adagrasib联合帕博利珠单抗一线治疗晚期/转移性KRASG12C突变NSCLC患者讲者：Pasi A. Jänne | Department of Medical Oncology, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8501研究英文名称：TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC).研究中文名称：TROPION‑Lung02研究：Dato-DXd联合帕博利珠单抗±铂类化疗一线治疗晚期NSCLC讲者：Benjamin Philip Levy | Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine摘要号：LBA8502研究英文名称：CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC): A randomized, single-blind, multicenter phase 3 study.研究中文名称：CAMPASS研究：贝莫苏拜单抗联合安罗替尼对比帕博利珠单抗一线治疗晚期NSCLC：一项随机、单盲、多中心III期研究讲者：韩宝惠 | 上海交通大学医学院附属胸科医院摘要号：8503研究英文名称：Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab.研究中文名称：zipalertinib对既往接受过含或不含埃万妥单抗铂类化疗的EGFR外显子20插入突变NSCLC患者的疗效评估讲者：Helena Alexandra Yu | Memorial Sloan Kettering Cancer Center摘要号：8504研究英文名称：SOHO-01: Safety and efficacy of BAY 2927088 in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) who were pretreated but naïve to HER2-targeted therapy or had not received any treatment for advanced disease.研究中文名称：SOHO-01研究：BAY 2927088治疗既往接受过治疗但未接受HER2靶向治疗或未接受过任何治疗的晚期HER2突变NSCLC患者的疗效和安全性研究讲者：Herbert H. Loong | 香港中文大学摘要号：LBA8505研究英文名称：Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study.研究中文名称：赛沃替尼联合奥希替尼对比化疗治疗EGFR-TKI治疗进展后EGFR突变伴MET扩增的晚期NSCLC：来自III期随机SACHI研究结果讲者：陆舜 | 上海市胸科医院摘要号：8506研究英文名称：Patritumab deruxtecan (HER3-DXd) in resistant EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) after a third-generation EGFR TKI: The phase 3 HERTHENA-Lung02 study.研究中文名称：Patritumab-deruxtecan（HER3-DXd）治疗第三代EGFR-TKI治疗后耐药的EGFR突变晚期NSCLC：III期HERTHENA-Lung02研究讲者：莫树锦 | 香港中文大学摘要号：8507研究英文名称：Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study.研究中文名称：芦康沙妥珠单抗（sac-TMT）治疗既往接受过治疗的晚期EGFR突变NSCLC：来自OptiTROP-Lung03随机研究的结果讲者：张力 | 中山大学肿瘤防治中心Rapid Oral Abstract Session快速口头报告专场摘要号：8009研究英文名称：Association of post-surgical MRD status with neoadjuvant ctDNA dynamics, genomic mutations, and clinical outcomes in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.研究中文名称：III期AEGEAN研究：术后MRD状态与新辅助ctDNA动态、基因突变特征及可切除NSCLC患者预后的相关性分析讲者：Martin Reck | Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research摘要号：LBA8010研究英文名称：Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: Updated survival and biomarker analyses from CheckMate 77T.研究中文名称：CheckMate 77T研究：可切除NSCLC患者围手术期纳武利尤单抗对比安慰剂治疗的生存及生物标志物更新分析讲者：Mariano Provencio | Hospital Universitario Puerta de Hierro摘要号：8011研究英文名称：ctDNA-based MRD detection in unresectable NSCLC undergoing curatively intended chemoradiotherapy and durvalumab.研究中文名称：在接受根治性放化疗及度伐利尤单抗治疗的不可切除NSCLC患者中基于ctDNA的MRD检测讲者：Aslaug Helland | University of Oslo, Clinical Medicine摘要号：8012研究英文名称：The preliminary results of a randomized phase II trial evaluating induction toripalimab plus chemotherapy followed by concurrent chemoradiotherapy and consolidation toripalimab in bulky unresectable stage III non-small-cell lung cancer (InTRist).研究中文名称：InTRist研究：评估特瑞普利单抗联合诱导化疗，随后同步放化疗及特瑞普利单抗巩固治疗用于巨大不可切除的III期NSCLC的随机II期试验的初步结果讲者：Yu Wang | 中国医学科学院肿瘤医院摘要号：8013研究英文名称：Safety and efficacy of lurbinectedin plus atezolizumab as second-line treatment for advanced small-cell lung cancer: Results of the 2SMALL phase 1/2 study (NCT04253145).研究中文名称：I/II期2SMALL研究：芦比替定联合阿替利珠单抗作为晚期NSCLC二线治疗的疗效和安全性讲者：Santiago Ponce Aix | Hospital Universitario 12 de Octubre and Oncosur Foundation摘要号：8014研究英文名称：Clinical and molecular characteristics of early progressors (EPs) and long-term progression-free survivors (LTPs) from the phase 3 ADRIATIC trial of consolidation durvalumab (D) vs placebo (P) after concurrent chemoradiotherapy (cCRT) in limited-stage small-cell lung cancer (LS-SCLC).研究中文名称：III期ADRIATIC研究：同步放化疗后巩固度伐利尤单抗对比安慰剂治疗用于LS-SCLC患者中早期进展者与长期无进展生存者的临床与分子特征讲者：David Allen Barbie | Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8015研究英文名称：Alectinib as neoadjuvant treatment in potentially resectable stage III ALK-positive NSCLC: Final analysis of ALNEO phase II trial (GOIRC-01-2020-ML42316).研究中文名称：阿来替尼作为新辅助治疗用于潜在可切除III期ALK阳性NSCLC的ALNEO II期研究最终分析（GOIRC-01-2020-ML42316）讲者：Marcello Tiseo | Department of Medicine and Surgery, University of Parma; Medical Oncology Unit, University Hospital of Parma; Gruppo Oncologico Italiano di Ricerca Clinica, GOIRC摘要号：8016研究英文名称：Efficacy and safety of nivolumab plus ipilimumab for patients with pre-treated type B3 thymoma and thymic carcinoma: Results from the EORTC-ETOP NIVOTHYM phase II trial.研究中文名称：纳武利尤单抗联合伊匹木单抗治疗经治的B3型胸腺瘤和胸腺癌患者的疗效与安全性：EORTC-ETOP NIVOTHYM II期研究结果讲者：Nicolas Girard, MD | Institut du Thorax Curie Montsouris, Institut Curie, Paris, and UVSQ, Paris Saclay University摘要号：8017研究英文名称：Integrin αVβ3-targeted imaging for identification of lung cancer and mapping of lymph-node metastases: A prospective, multicenter, self-controlled phase 3 trial (TRIIL study).研究中文名称：靶向整合素αVβ3的成像用于肺癌的识别和淋巴结转移的定位：一项前瞻性、多中心、自身对照的III期试验（TRIIL研究）讲者：Rongxi Wang | 北京协和医院摘要号：8512研究英文名称：Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met protein–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced EGFR-mutated (MT) non-squamous (NSQ) non-small cell lung cancer (NSCLC): Results from a phase 1 study.研究中文名称：靶向c-Met的抗体偶联药物（ADC）Telisotuzumab adizutecan（ABBV-400；Temab-A）治疗晚期EGFR突变非鳞NSCLC的I期研究结果讲者：David Ross Camidge | University of Colorado Cancer Center摘要号：8513研究英文名称：Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO).研究中文名称：II期SAVANNAH研究随机亚组结果：赛沃替尼联合奥希替尼对比赛沃替尼联合安慰剂的疗效及中枢神经系统结果分析讲者：Benjamin Philip Levy | Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine摘要号：8514研究英文名称：Phase 3 study of benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC).研究中文名称：贝莫苏拜单抗联合化疗，随后序贯联合安罗替尼一线治疗局部晚期或转移性鳞状NSCLC的III期研究讲者：石远凯 | 中国医学科学院肿瘤医院摘要号：8515研究英文名称：Plasma-guided adaptive first-line chemoimmunotherapy for non-small cell lung cancer (NSCLC).研究中文名称：血浆引导的NSCLC一线个体化化免治疗探索讲者：Julia K. Rotow | Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8516研究英文名称：Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer.研究中文名称：NSCLC患者免疫化疗时间与无进展生存期及总生存期相关性的随机试验讲者：张永昌 | 湖南省肿瘤医院摘要号：8517研究英文名称：Hypoxia-responsive CEA CAR-T cells therapy for relapsed or refractory non-small cell lung cancer: A single-arm, open-label, phase I trial.研究中文名称：缺氧反应型CEA CAR-T细胞疗法治疗复发或难治性NSCLC：一项单臂、开放标签、I期试验讲者：魏双 | 华中科技大学同济医学院附属同济医院摘要号：8518研究英文名称：S1900E: A phase II study examining impact of co-mutations on sotorasib for previously treated stage IV/recurrent KRAS G12C mutated (MUT) non-squamous (Non-sq) non-small cell lung cancer (NSCLC) (ECOG-ACRIN led Lung-MAP Sub-study).研究中文名称：S1900E研究：评估合并突变对sotorasib治疗经治的KRAS G12C突变IV期/复发性非鳞NSCLC疗效影响的II期研究（ECOG-ACRIN主导Lung-MAP子研究）讲者：Sukhmani Kaur Padda | Fox Chase Cancer Center/Temple Health摘要号：8519研究英文名称：Safety and efficacy of olomorasib + immunotherapy in first-line treatment of patients with KRAS G12C-mutant advanced NSCLC: Update from the LOXO-RAS-20001 trial.研究中文名称：Olomorasib联合免疫治疗用于KRAS G12C突变晚期NSCLC一线治疗的疗效和安全性：LOXO-RAS-20001研究更新讲者：Konstantin H. Dragnev | Dartmouth Cancer Center摘要号：8520研究英文名称：Sosimerasib monotherapy in patients with previously treated KRAS G12C–mutated non-small cell lung cancer: Primary results of a phase 2 study.研究中文名称：Sosimerasib单药治疗KRAS G12C突变NSCLC：II期研究的主要结果讲者：王洁 | 中国医学科学院肿瘤医院摘要号：LBA8671研究英文名称：PRAGMATICA-LUNG (SWOG S2302): A prospective, randomized study of ramucirumab plus pembrolizumab versus standard of care for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer.研究中文名称：Practicala-LUNG研究（SWOG S2302）：雷莫芦单抗联合帕博利珠单抗对比标准治疗用于既往接受过免疫治疗的IV期或复发性NSCLC患者的前瞻性随机研究讲者：Konstantin H. Dragnev | Dartmouth Cancer CenterClinical Science Symposium临床科学研讨会摘要号：8509研究英文名称：First-in-class PD-1/IL-2 bispecific antibody IBI363 in patients (Pts) with advanced immunotherapy-treated non-small cell lung cancer (NSCLC).研究中文名称：首创新药PD-1/IL-2双特异性抗体IBI363治疗经免疫治疗的晚期NSCLC患者讲者：周建娅 | 浙江大学医学院附属第一医院摘要号：8510研究英文名称：Efficacy and safety of MHB088C, a novel B7-H3-targeted ADC, in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC): Subgroup analysis from a phase 1/2 multicenter study.研究中文名称：一项评估新型靶向B7-H3的ADCMHB088C治疗复发ES-SCLC的疗效与安全性的I/II期多中心研究的亚组分析讲者：周彩存 | 同济大学附属东方医院摘要号：8511研究英文名称：First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line treatment (1L) in unresectable malignant mesothelioma.研究中文名称：首个评估BNT327/PM8002联合化疗作为不可切除恶性胸膜间皮瘤一线治疗的II期试验的疗效及安全性结果报告讲者：程颖 | 吉林省肿瘤医院备注：如有遗漏或任何问题，请给我们留言~声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：医脉通胸部肿瘤编辑：lagertha审核：南星

抗体药物偶联物临床结果ASCO会议临床1期

2025-05-27

·医药魔方

药械合作的“来时路”：一款创新药物的伴随诊断极致布局

2025年2月，强生公司的埃万妥单抗注射液（锐珂®）（Amivantamab, Rybrevant®）在中国获批上市：与卡铂和培美曲塞联合给药，用于经检测确认携带EGFR 20号外显子插入（exon20ins）突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。4月底，埃万妥单抗的第二个适应症在华获批：联合卡铂和培美曲塞，治疗携带EGFR exon19del或L858R，经EGFR-TKI治疗进展的晚期非鳞状NSCLC患者。同年的4月、5月，埃万妥单抗的两款原研伴随诊断（组织和血浆）依次获得NMPA批准。而这两个用途，均搭载于制造业单项冠军企业艾德生物的同一款产品——人类10基因突变联合检测试剂盒（可逆末端终止测序法）。这款试剂盒，曾在2018年首次通过NMPA创新医疗器械审查通道获批上市：作为治疗肺癌和肠癌关键靶向药物的伴随诊断，已经服务中国临床七个年头。本次获批是增加了EGFR exon20ins的CDx标签，以及第二个全新用途——血浆检测。埃万妥单抗何许人也埃万妥单抗是一款双特异性抗体，可以同时靶向结合EGFR和MET的胞外域，施加双重抗癌机制：它阻断配体结合，诱导EGFR和MET降解，从而阻扰其信号传递；它亦可通过免疫效应细胞，靶向杀伤肿瘤细胞。如此高效的作用机制，造就了埃万妥单抗优异的治疗效果——NCCN指南关于埃万妥单抗的用药推荐：1类推荐——联合卡铂和培美曲塞，一线治疗EGFR exon20ins晚期的NSCLC（非鳞癌）患者；1类推荐——联合拉泽替尼（lazertinib），一线治疗携带EGFR exon19del/L858R的NSCLC患者；1类推荐——联合化疗，后续治疗经奥希替尼治疗进展、携带EGFR exon19del/L858R的晚期NSCLC患者；2A类推荐——后续治疗经铂类化疗进展、携带EGFR exon20ins的NSCLC患者。自从2021年FDA首次批准上市后，埃万妥单抗一路高歌猛进，从单药到组合，从一线到后线，从罕见靶点（EGFR exon20ins）到常见靶点（EGFR 19del/L858R），每一项研究都蕴藏着“敢教日月换新天”的期许和能量。伴随诊断——“优等生”的晋级之路在创新药物全球商业化的进程中，每项新适应症的获批，都会增加广泛的适用人群；而每治疗一名患者，便肩负了一份承诺，一份责任。强生作为全球药企，对药物/诊断的协同布局可谓追求到了极致：纵观埃万妥单抗的成长过程，在全球主要的区域市场，强生都为其搭建了药物与CDx产品的生态系统，以应对各国独特的法规要求，采用最高的标准来确认适用的患者人群，从而确保治疗获益的稳定输出。在美国、日本、中国，埃万妥单抗为了有效定位患者，采用了两种最有效的技术路径：收集肿瘤组织（FFPE）和血浆（plasma）样本，使用在本国获批上市的伴随诊断试剂盒进行分子检测，获得EGFR基因的exon20ins突变结果，从而确认患者是否可以接受治疗。因此，强生在每个国家的市场，通过合作开发的方式，分别布局了“组织+血浆”至少两款CDx产品。尤其是在日本，由于实行的是药物-诊断-医保强绑定的临床应用模式，强生也为药物补充了区域性诊断策略：对于联用EGFR-TKI的适应症，需要识别EGFR常见突变（exon19del和L858R），强生选择了在日本NSCLC临床市占率颇高的产品——艾德生物的人类肺癌11基因（PCR）试剂盒（AmoyDx® Pan Lung Cancer PCR Panel）合作申报伴随诊断[1]，可谓将诊断合规做到极致。伴随诊断——创新药生态的重要一环对于CDx的系统性布局，强生并不是独家：各家跨国药企，为创新抗肿瘤药物，都搭建了完整的生态；专注于生物标志物的高水准诊断产品，正是创新药物生态搭建的支柱。与原研CDx的协同开发，是靶向机制药物上市的必备条件，也是嵌入创新药生命周期的“护身锦囊”。在机遇与风险并存、规则与认知震荡上升的当下，坚守科学本质的“笨办法”，往往才是唯一的捷径。以血浆检测为例，我们穷举在美国获批上市的伴随诊断（液体活检）产品清单，不难看出，肺癌、肠癌、乳腺癌、前列腺癌这些瘤种，已经有成熟的血浆检测临床共识，血浆CDx是药物上市的必选项；而跨国药企的畅销药物，大多都承载了血浆CDx的开发使命。这些创新的CDx产品，开发难度大，而一旦成功上市，却能有效地拓宽适用人群，是药物大规模推广的公认前提。FDA批准的血浆伴随诊断一览（更新至2025年4月）中国伴随诊断，生态正在成长自从2018年，NMPA开始按照“伴随诊断（CDx）”的标准，审批靶向药物相关的IVD产品以来，药物开发者、诊断开发者们，便与监管部门一道展开了执着的探索。尤其是创新药，与CDx的协同开发、共同上市，是产品合规应用的必备保障，也是临床循证的必经之路。过去几年，中国的原研CDx产品的数量已经有了可喜的积累，然而药物/诊断的获批节奏普遍难以同步：上市时间相差一年已经算是乐观情况；更有甚者，药物上市前承诺过的原研CDx计划，挣扎多年无法落实、苦苦找人接盘的也大有人在，此中过程不可谓不艰苦。创新药与CDx的上市时间差，导致标准诊断方法的可及性困难——这使得患者接受的治疗决策，经常暴露在丛林般的信息来源中；而对于靶向驱动的抗肿瘤治疗来说，CDx的缺失，给临床应用蒙上了一层难以预测的合规风险。道虽远，行则将至回到开篇，一款创新药、两款原研伴随诊断、三个月内在国内相继上市——这个协同节奏之紧凑，令人眼前一亮。一家国际顶级药企，一个伴随诊断龙头，强生与艾德交出的这份答卷，实乃在中国药监体系的监督与激励下，药械合作的一次优秀示范。艾德生物的这款NGS试剂盒，适用于两个适应症（肺癌和结直肠癌）的10个临床决策基因：EGFR、ALK、ROS1、RET、KRAS、NRAS、PIK3CA、BRAF、HER2和MET。随着“肿瘤组织+血浆”EGFR exon20ins伴随诊断标签的入列，这款产品将继续作为中国肿瘤CDx的前哨，探索药物与器械协同上市、临床获益模式的新边界。我们也能看到，未来会有更多如强生一样的企业：作为敬畏科学、敢于突破的实践者，加码中国创新药生态的先行者，选择志向相投的合作者，搭建出属于自己的行业丰碑。Copyright © 2025 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

上市批准诊断试剂

100 项与埃万妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	埃万妥单抗	L01	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
EGFR阳性非小细胞肺癌	日本	Janssen Pharmaceutical KK	2025-03-27
EGFR 外显子 19 缺失突变型非小细胞肺癌	美国	Janssen Biotech, Inc.	2024-08-19
EGFR外显子21替代突变非小细胞肺癌	美国	Janssen Biotech, Inc.	2024-08-19
非小细胞肺癌	加拿大	Janssen, Inc.	2022-03-30
EGFR 20号外显子插入突变非小细胞肺癌	美国	Janssen Biotech, Inc.	2021-05-21

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
EGFR突变的非小细胞肺癌	申请上市	中国	Cilag AG	2024-01-26
EGFR突变的非小细胞肺癌	申请上市	中国	Janssen-Cilag International NV	2024-01-26
EGFR突变的非小细胞肺癌	申请上市	中国	上海强生制药有限公司	2024-01-26
结直肠癌	临床3期	美国	Janssen Research & Development LLC	2024-12-12
结直肠癌	临床3期	中国	Janssen Research & Development LLC	2024-12-12
结直肠癌	临床3期	日本	Janssen Research & Development LLC	2024-12-12
结直肠癌	临床3期	澳大利亚	Janssen Research & Development LLC	2024-12-12
结直肠癌	临床3期	比利时	Janssen Research & Development LLC	2024-12-12
结直肠癌	临床3期	巴西	Janssen Research & Development LLC	2024-12-12
结直肠癌	临床3期	法国	Janssen Research & Development LLC	2024-12-12

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02609776 (CHRYSALIS \| CHRYSALIS, CHRYSALIS-2, LASER201 \| CHRYSALIS Phase I Study, Pubmed) 人工标引	N/A	MET外显子14跳变的非小细胞肺癌 MET Exon 14 Skipping	97	Amivantamab	網築獵窪餘憲餘網餘廠(鏇襯製鹹壓鏇築築糧遞) = 積淵製餘鑰艱遞獵築積網鬱鑰艱製觸蓋夢製鑰 (顧簾窪積製鬱衊憲構艱 ) 更多	积极	2025-05-01
				Amivantamab (treatment naïve)	網築獵窪餘憲餘網餘廠(鏇襯製鹹壓鏇築築糧遞) = 齋夢願鏇積選範窪簾憲網鬱鑰艱製觸蓋夢製鑰 (顧簾窪積製鬱衊憲構艱 ) 更多
NCT04988295 (MARIPOSA-2, CTgov)	临床3期	EGFR突变的非小细胞肺癌	776	ACP-L+Amivantamab+Carboplatin+Pemetrexed+Lazertinib (Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L))	簾鏇夢鏇選鹹齋鏇範獵(選鬱顧簾膚膚餘願憲顧) = 廠積鑰鏇壓衊膚製艱醖願憲獵廠網築觸鹽廠鹹 (淵簾壓鏇衊齋獵衊膚鹹, 糧簾壓衊簾構獵壓蓋艱 ~ 蓋艱鹹齋遞蓋積艱選願) 更多	-	2025-04-16
				Carboplatin+Pemetrexed (CP) (Main Study: Arm B: Carboplatin + Pemetrexed (CP))	簾鏇夢鏇選鹹齋鏇範獵(選鬱顧簾膚膚餘願憲顧) = 遞範齋鹹餘願鹹蓋願簾願憲獵廠網築觸鹽廠鹹 (淵簾壓鏇衊齋獵衊膚鹹, 蓋憲襯觸鏇遞糧築範蓋 ~ 淵窪鬱鏇衊醖積遞積選) 更多
NCT05601973 (AMAZE-lung, ESMO_ELCC2025) 人工标引	临床2期	EGFR突变的非小细胞肺癌 EGFR Mutation	61	Amivantamab+lazertinib+bevacizumab	選膚獵糧蓋齋築淵鏇餘(網遞鹽選繭膚醖襯壓艱) = 獵鹹壓艱餘艱蓋簾觸網壓顧蓋壓襯願餘範襯襯 (繭糧醖艱夢鑰構衊積築, 21 ~ 47) 达到更多	积极	2025-03-27
NCT06120140 (COCOON, ESMO_ELCC2025) 人工标引	临床2期	EGFR突变的非小细胞肺癌一线 EGFR Exon 19 Deletion \| EGFR L858R	138	amivantamab+lazertinib	憲壓廠衊範願構簾繭憲(遞蓋壓積餘觸遞鬱積簾) = 顧廠觸鹹選糧鬱選鹹襯膚蓋蓋憲網簾積襯積範 (鬱艱壓襯選壓觸窪觸艱 ) 达到更多	积极	2025-03-27
				SoC	憲壓廠衊範願構簾繭憲(遞蓋壓積餘觸遞鬱積簾) = 鹹廠獵繭蓋餘蓋遞艱淵膚蓋蓋憲網簾積襯積範 (鬱艱壓襯選壓觸窪觸艱 ) 达到更多
NCT04077463 (CHRYSALIS-2, ESMO_ELCC2025) 人工标引	临床1期	EGFR突变的非小细胞肺癌 EGFR Mutation	49	Amivantamab plus Lazertinib	鹽醖獵觸鑰艱衊簾願鑰(齋遞願蓋獵網繭壓蓋夢) = 鬱顧願齋積觸鹹鏇鏇鑰獵夢淵鬱選顧獵糧淵齋 (廠襯構鏇積願構顧製糧 ) 更多	积极	2025-03-26
				EGFR TKIs (Osimertinib, Afatinib)	鹽醖獵觸鑰艱衊簾願鑰(齋遞願蓋獵網繭壓蓋夢) = 蓋憲繭淵積積願艱鏇鹽獵夢淵鬱選顧獵糧淵齋 (廠襯構鏇積願構顧製糧 ) 更多
NCT04487080 (MARIPOSA, ESMO_ELCC2025) 人工标引	临床3期	EGFR突变的非小细胞肺癌一线 EGFR L858R \| EGFR Exon 19 Deletion	-	Amivantamab plus Lazertinib	繭鹹遞餘壓廠壓鏇顧網(餘鑰簾顧構淵範艱壓願) = 壓醖廠淵鏇範齋廠願願餘範壓選簾觸製鹹憲積 (醖築窪醖簾繭糧憲衊壓, 42.9 ~ NE) 更多	积极	2025-03-26
				Osimertinib	繭鹹遞餘壓廠壓鏇顧網(餘鑰簾顧構淵範艱壓願) = 構獵範廠築願願願觸夢餘範壓選簾觸製鹹憲積 (醖築窪醖簾繭糧憲衊壓, 33.4 ~ 41.0) 更多
ATLAS (ESMO_ELCC2025)	N/A	EGFR Exon 20 insertion mutations	64	Amivantamab	壓範餘餘膚鹽構壓餘網(艱糧願鬱壓糧繭積窪襯) = 53.1% with G33 in 7.8% 憲獵膚艱顧選醖遞觸顧 (積鹹襯構製範醖選衊遞 ) 更多	积极	2025-03-26
NCT05379595 (OrigAMI-1, ASCO_GI2025) 人工标引	临床1/2期	转移性结直肠癌	30	Amivantamab monotherapy	構蓋願窪糧鏇淵鏇憲餘(襯鹹衊蓋顧願醖範衊膚) = 網簾鹽願蓋鹹醖艱蓋鹽襯願糧構網壓構憲繭廠 (範鬱構築糧艱遞糧簾廠, 56 ~ 93) 更多	积极	2025-01-23
				Amivantamab + FOLFOX or FOLFIRI	構蓋願窪糧鏇淵鏇憲餘(襯鹹衊蓋顧願醖範衊膚) = 鬱網廠蓋範膚鹽繭製簾襯願糧構網壓構憲繭廠 (範鬱構築糧艱遞糧簾廠, 42 ~ 100) 更多
NCT04487080 (MARIPOSA, Company_Website) 人工标引	临床3期	非小细胞肺癌一线 EGFR Exon 19 Deletion \| EGFR L858R	1,074	RYBREVANT+LAZCLUZE	構獵選廠鏇憲獵壓醖範(夢獵餘壓鏇積鏇簾廠鏇) = clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib. Improvement in median OS is expected to exceed one year. 廠願顧壓餘淵願糧積鏇 (鬱繭觸遞蓋獵餘遞窪簾 ) 达到	积极	2025-01-07
				osimertinib
NCT04077463 (CHRYSALIS-2, Pubmed) 人工标引	临床1期	EGFR突变的非小细胞肺癌 EGFR L858R \| EGFR Exon 19 Deletion	162	Amivantamab 1050 mg + Lazertinib 240 mg	蓋鹹衊壓襯衊餘餘繭觸(遞構鬱範憲蓋夢齋憲願) = 餘鑰窪糧夢簾廠製襯遞齋鹽網衊鑰鬱夢夢衊襯 (鹹艱繭願糧衊齋鬱淵構, 22 ~ 36) 更多	积极	2025-01-02