埃万妥珠单抗(Amivantamab-VMJM) - 药物靶点：EGFR x c-Met_在研适应症：EGFR 20号外显子插入突变非小细胞肺癌，EGFR突变的非小细胞肺癌，EGFR 外显子 19 缺失突变型非小细胞肺癌_专利_临床

概要

基本信息

药物类型

双特异性抗体

别名

Amivantamab、amivantamab-vmjw、EM1-mAb DuoBody(Janssen Global Services LLC)

+ [6]

靶点

EGFR x c-Met

作用机制

EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)、c-Met抑制剂(肝细胞生长因子受体抑制剂)

治疗领域

肿瘤呼吸系统疾病消化系统疾病

在研适应症

EGFR 20号外显子插入突变非小细胞肺癌EGFR突变的非小细胞肺癌EGFR 外显子 19 缺失突变型非小细胞肺癌+ [13]

非在研适应症

晚期肝细胞癌食管癌胃癌

原研机构

Genmab BV

Janssen Biotech, Inc.

在研机构

Janssen Research & Development LLCJanssen-Cilag International NV

强生（中国）投资有限公司

+ [7]

非在研机构

Genmab A/S

最高研发阶段批准上市

首次获批日期

美国 (2021-05-21),

EGFR 20号外显子插入突变非小细胞肺癌

最高研发阶段(中国)申请上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、加速批准 (美国)、突破性疗法 (中国)

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序列信息

Sequence Code 143885L

来源: *****

Sequence Code 13387733H

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Sequence Code 13387743H

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Sequence Code 13387747L

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关联

42

项与埃万妥珠单抗相关的临床试验

NCT06116682 / Not yet recruiting临床2期IIT

A Phase II Study of Amivantamab in Participants With MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-vmjw works in treating patients patients with MET amplification non-small cell lung cancer. Amivantamab-vmjw is a drug that reduces extra copies of the MET gene, a change present in your tumor. Giving amivantamab-vmjw may lower the chance of the growth or spread of advanced non-small cell lung cancer that has extra copies of the MET gene in the tumor.

开始日期2024-07-16

申办/合作机构

National Cancer Institute

NCT06147037 / Not yet recruiting临床1期

A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of [225Ac]-FPI-2068, [111In]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC).

开始日期2024-06-28

申办/合作机构

Fusion Pharmaceuticals, Inc.

[+1]

NCT06083857 / Recruiting临床1/2期IIT

An Open-Label Phase I/II Study to Evaluate the Safety and prelimiBasnary Efficacy of Amivantamab and Tepotinib Combination in MET-altered Non-small Cell Lung Cancer (NSCLC)

To learn if the combination of amivantamab and tepotinib can help to control NSCLC. The safety of this drug combination will also be studied.

开始日期2024-06-18

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与埃万妥珠单抗相关的临床结果

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100 项与埃万妥珠单抗相关的转化医学

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100 项与埃万妥珠单抗相关的专利（医药）

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99

项与埃万妥珠单抗相关的文献（医药）

2024-03-01·Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

Real-World Efficacy and Safety of Amivantamab for EGFR-Mutant NSCLC

Article

作者: Vaporciyan, Ara A ; Byers, Lauren A ; Wang, Kaiwen ; Myall, Nathaniel J ; Tu, Janet ; Riess, Jonathan W ; Rinsurongkawong, Waree ; Baik, Christina ; Lewis, Whitney E ; Negrao, Marcelo V ; Le, Xiuning ; Lee, J Jack ; Behl, Deepti ; Tsao, Anne ; Skoulidis, Ferdinandos ; Hong, Lingzhi ; Zhang, Jianjun ; Du, Robyn ; Gibbons, Don L ; Heymach, John V ; Park, Keunchil ; Shu, Catherine A ; Pozadzides, Jenny ; Wakelee, Heather A ; Uy, Natalie ; Gandara, David ; Cascone, Tina

INTRODUCTION:

Amivantamab-vmjw (amivantamab) is a bispecific EGFR/MET antibody approved for patients with advanced NSCLC with EGFR exon 20 insertion mutations, after prior therapy. Nevertheless, the benefits and safety of amivantamab in other EGFR-mutant lung cancer, with or without osimertinib, and with concurrent radiation therapy, are less known.

METHODS:

We queried the MD Anderson Lung Cancer GEMINI, Fred Hutchinson Cancer Research Center, University of California Davis Comprehensive Cancer Center, and Stanford Cancer Center's database for patients with EGFR-mutant NSCLC treated with amivantamab, not on a clinical trial. The data analyzed included initial response, duration of treatment, and concomitant radiation safety in overall population and prespecified subgroups.

RESULTS:

A total of 61 patients received amivantamab. Median age was 65 (31-81) years old; 72.1% were female; and 77% were patients with never smoking history. Median number of prior lines of therapies was four. On the basis of tumor's EGFR mutation, 39 patients were in the classical mutation cohort, 15 patients in the exon 20 cohort, and seven patients in the atypical cohort. There were 37 patients (58.7%) who received amivantamab concomitantly with osimertinib and 25 patients (39.1%) who received concomitant radiation. Furthermore, 54 patients were assessable for response in the overall population; 19 patients (45.2%) had clinical response and disease control rate (DCR) was 64.3%. In the classical mutation cohort of the 33 assessable patients, 12 (36.4%) had clinical response and DCR was 48.5%. In the atypical mutation cohort, six of the seven patients (85.7%) had clinical response and DCR was 100%. Of the 13 assessable patients in the exon 20 cohort, five patients (35.7%) had clinical response and DCR was 64.3%. Adverse events reported with amivantamab use were similar as previously described in product labeling. No additional toxicities were noted when amivantamab was given with radiation with or without osimertinib.

CONCLUSIONS:

Our real-world multicenter analysis revealed that amivantamab is a potentially effective treatment option for patients with EGFR mutations outside of exon 20 insertion mutations. The combination of osimertinib with amivantamab is safe and feasible. Radiation therapy also seems safe when administered sequentially or concurrently with amivantamab.

2024-03-01·Nature reviews. Clinical oncology

Chemotherapy in EGFR-mutated NSCLC: optimizing combinations with TKIs and amivantamab

Article

作者: González-Cao, María ; Rosell, Rafael

2024-03-01·Annals of oncology : official journal of the European Society for Medical Oncology

Correspondence to: Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study

Letter

作者: Moik, F ; Riedl, J M ; Ay, C

407

项与埃万妥珠单抗相关的新闻（医药）

2024-07-01

·drugs

Amivantamab-Lazertinib Ups Survival in EGFR-Mutated Advanced Lung Cancer

MONDAY, July 1, 2024 -- For patients with EGFR -mutated advanced non-small cell lung cancer ( NSCLC ), amivantamab -lazertinib yields improved progression-free survival compared with osimertinib as first-line treatment, according to a study published online June 26 in the New England Journal of Medicine . Byoung C. Cho, M.D., Ph.D., from the Yonsei Cancer Center in Seoul, South Korea, and colleagues conducted a phase 3 trial involving patients with previously untreated EGFR -mutated, locally advanced or metastatic NSCLC randomly allocated to receive amivantamab-lazertinib (open-label), osimertinib (blinded), or lazertinib (blinded) in a 2:2:1 ratio (429, 429, and 216 patients, respectively). The researchers found that the median progression-free survival was significantly longer in the amivantamab-lazertinib group than in the osimertinib group (23.7 versus 16.6 months; hazard ratio for disease progression or death, 0.70). An objective response was observed in 86 and 85 percent of patients in the amivantamab-lazertinib and osimertinib groups, respectively; among patients with a confirmed response, the median response duration was 25.8 and 16.8 months, respectively. The hazard ratio for death did not differ significantly in a planned interim overall survival analysis of amivantamab-lazertinib versus osimertinib. EGFR -related toxic effects were the predominant adverse events. The incidence of discontinuation of all agents due to treatment-related adverse events was 10 and 3 percent with amivantamab-lazertinib and osimertinib, respectively. "We found that progression-free survival was significantly improved with amivantamab-lazertinib as compared with osimertinib as first-line treatment for EGFR -mutated advanced NSCLC," the authors write. Several authors disclosed ties to biopharmaceutical companies, including Janssen, which manufactures amivantamab and lazertinib and funded the study.

临床结果临床3期ASCO会议

2024-07-01

·PMLiVE

Johnson & Johnson’s Rybrevant granted EC approval for first-line NSCLC use

Johnson & Johnson’s (J&J) Rybrevant (amivantamab) has been approved by the European Commission (EC) as a first-line treatment for non-small cell lung cancer (NSCLC). The bispecific antibody has been specifically authorised for use alongside carboplatin and pemetrexed chemotherapy to treat advanced NSCLC in adults with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The approval builds on the EC’s December 2021 conditional marketing authorisation of the drug for use in the same patients after the failure of platinum-based therapy, which has now been converted to standard marketing authorisation. The regulator’s latest decision was supported by positive results from the late-stage PAPILLON study, in which Rybrevant plus chemotherapy was associated with a statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy alone. An interim overall survival analysis also showed a favourable trend for patients receiving the Rybrevant combination compared to those in the chemotherapy group. “Treatment with [Rybrevant] has already been established in the second-line setting, and with this approval in the first-line setting, [Rybrevant] combined with chemotherapy has the potential to redefine the standard of care, offering improved patient outcomes both in terms of clinical efficacy and quality of life,” said trial investigator Nicolas Girard, Institut Curie and Paris Saclay University. NSCLC accounts for up to 85% of all lung cancer cases and alterations in EGFR are the most common actionable driver mutations in patients with this form of the disease. EGFR exon 20 insertion mutations are associated with real-world five-year overall survival rates as low as 8%, J&J said, adding that this makes “the introduction of new targeted therapeutic approaches tailored to address the unique complexities of EGFR exon 20 insertion mutations critical”. Henar Hevia, senior director, EMEA therapeutic area lead, oncology, J&J Innovative Medicine, described the approval as “an important development for patients with EGFR exon 20 insertion-mutated NSCLC, who may now benefit from [Rybrevant] plus chemotherapy at the start of their treatment journey”. The approval announcement came on the same day that J&J said it had received a recommendation from the European Medicines Agency’s human medicines committee for the use of Balversa (erdafitinib) as a once-daily oral monotherapy for specific cases of urothelial carcinoma.

上市批准临床结果

2024-06-29

·药渡Daily

【药渡药闻报告-创新药篇】-2024年第24期/总第145期

全球药物批准/研发动态 01 全球新药批准情况根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）全球（不含中国）共有13个新药获批上市。其中，NDA批准2个，BLA批准3个，疫苗批准1个，新适应症批准7个，新剂型批准1个。与上个统计周期相比，本次增加8个批准新药。 6月17日，默沙东宣布FDA已批准CAPVAXIVE™（肺炎球菌21价结合疫苗）用于预防成人侵袭性肺炎球菌疾病和肺炎球菌肺炎。与其他肺炎球菌疫苗相比，CAPVAXIVE包括八种独特的血清型，即15A、15C、16F、23A、23B、24F、31和35B。这些血清型约占50岁及以上成年人IPD病例的27%，约占65岁及以上成年人的30%。CAPVAXIVE以单剂量给药。 6月20日，Sarepta宣布，FDA批准扩大ELEVIDYS的适应症，用于治疗4岁及以上DMD突变的杜氏肌营养不良症（DMD）患者，并加速批准ELEVIDYS用于非卧床杜氏患者。ELEVIDYS是一种基于腺相关病毒的单剂量基因转移疗法，用于静脉输注，通过递送编码骨骼肌中ELEVIDYS微抗肌萎缩蛋白的靶向生产的转基因，解决杜氏肌营养不良症的潜在遗传原因-DMD基因的突变或变化导致抗肌萎缩蛋白的缺乏。全球（不含中国）新药批准情况（部分） 02 全球新药申报进展根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）全球（不含中国）共有5个新药申报上市。其中，NDA申报进展2个，BLA申报进展3个。与上次统计周期相比，本次增加3个NDA/BLA申报。 6月17日，强生宣布向FDA提交sBLA，此sBLA为Amivantamab和重组人透明质酸酶的固定组合皮下给药用于目前所有批准或提交的Amivantamab静脉脉注射剂型的NSCLC相关适应症。数据显示，皮下注射Amivantamab能显著缩短给药时间，输注相关反应减少五倍，同时延长总生存期、无进展生存期和反应持续时间。 NDA/BLA申报根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）全球（不含中国）共有1个药物获监管机构特殊资格认定。其中，细胞疗法1个。与上次统计周期相比，本次减少6个获监管机构特殊资格认定的药物。 6月18日，Neurona Therapeutics宣布FDA已授予NRTX-1001 "RMAT加速计划"，用于治疗耐药性颞叶中叶癫痫（MTLE）。NRTX-1001细胞疗法与目前的手术方案不同，目前的手术方案会破坏脑组织，并可能导致包括神经认知障碍在内的严重不良反应，而NRTX-1001细胞疗法已显示出控制癫痫发作的潜力，且不会产生此类不良反应。如果这些研究结果得到证实，NRTX-1001将满足耐药性癫痫患者尚未得到满足的重大医疗需求。 NRTX-1001是一种候选再生细胞疗法，源自人类多能干细胞。目前，NRTX-1001正在两项开放标签多中心I/II期试验中进行安全性和有效性研究，这两项试验分别针对耐药单侧颞叶间叶癫痫和耐药双侧颞叶间叶癫痫，未来还计划研究新皮质局灶性癫痫和其他适应症。NRTX-1001细胞疗法正在进行的I/II期临床试验取得了积极的最新数据，显示出良好的安全性和显著降低耐药性癫痫发作频率的潜力。特殊资格认定情况 03 全球新药研发进展根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）全球（不含中国）新药临床研发状态更新共计58条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、神经疾病以及皮肤病等共计14个领域。其中，血液和淋巴疾病临床进展更新居各领域之首，为12条：血液和淋巴疾病领域涉及化学药7条，生物药1条，细胞疗法4条。 6月17日，科济药业宣布宣布，赛恺泽®的更新成果已在EHA年会上进行报告。结果显示，在既往经过至少3线治疗的R/R MM患者中，总体缓解率（ORR）为92.2%。中位随访时间为20.3个月时，DOR、PFS和OS尚未成熟，所有患者12个月和18个月的PFS率分别为76.3%和61.9%。所有患者12个月和30个月的OS率分别为90.2%和79.4%。在达到CR/sCR的患者中，12个月和30个月的OS率分别为95.9%和87.7%。全球新药研发进展详情（部分） 04 全球医药交易事件本次统计周期（2024.06.15-06.21）全球（含中国）医药交易时间共计46起，涉及药物权益转让、公司并购等多起交易事件。全球医药交易时间汇总表（部分）国内药物批准/研发动态 01 国内新药批准情况根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）国内共有7个新药获NMPA批准上市。其中，NDA批准3个，新适应症批准2个，新剂型批准2个。与上次统计周期相比，本次增加4个NMPA批准新药。 6月18日，康哲药业宣布亚甲蓝肠溶缓释片（莱芙兰®）的新药上市许可申请已于6月11日获得NMPA批准。产品用于在接受结肠镜检查筛查或监测的成人患者中增强结直肠病变的可视化，成为中国首个口服亚甲蓝肠溶缓释片。莱芙兰®采用多基质（MMX）的专利技术，将活性物质直接输送至结肠并局部控制释放，可增加结直肠病变和健康粘膜之间的对比度，显著提高非息肉样结直肠病变检出率，提高危险病变如非息肉样腺瘤的检测率。 6月19日，迪哲医药宣布高选择性JAK1抑制剂高瑞哲®正式获得NMPA批准，单药适用于既往至少接受过一线系统性治疗的复发或难治的外周T细胞淋巴瘤（r/r PTCL）成人患者。研究结果显示，高瑞哲®单药治疗r/r PTCL：深度缓解：经IRC确认的ORR达44.3%，完全缓解率达23.9%；全面获益：在不同亚型PTCL中均观察到肿瘤缓解，满足了既往药物无法覆盖的治疗需求；更长生存：中位缓解持续时间长达20.7个月。中国新药批准情况（部分） 02 国内新药临床默示许可进展根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）国内共有32个新药获临床默示许可，涉及50个受理号。其中，化学药15个，治疗用生物制品17个。与上个统计周期相比，本次增加28个临床默示许可获批受理号。本周国内新药临床默示许可进展（部分） 03 国内新药申报进展根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）国内共有4个新药申报上市，涉及7个受理号。其中，化药1个，治疗用生物制品3个。与上个统计周期相比，本次增加4个新药申报上市受理号。国内新药申报上市情况（部分）根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）国内共有35个新药申报临床，涉及45个受理号。其中，化学药18个，治疗用生物制品16个，预防用生物制品1个。与上个统计周期相比，本次减少4个临床申报受理号。国内新药临床申报情况（部分）根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）国内共有1个药物获NMPA特殊资格认定。其中，化学药1个。与上个统计周期相比，本次获监管机构特殊资格认定的药物数量与上个统计周期相同。 6月17日，CDE官网公示，礼邦医药的AP306胶囊拟纳入突破性治疗品种，拟开发的适应症为慢性肾脏病高磷血症。AP306是一种口服磷酸盐转运蛋白NaPi-IIb、PiT-1、PiT-2泛抑制剂，能阻断肠道磷酸盐主动转运，有望克服低磷饮食和磷结合剂治疗高磷血症的局限性，目前已完成针对慢性肾脏病高磷血症的II期临床研究。研究数据显示：在主要疗效终点，即从基线到治疗结束时血清磷平均值的变化方面，达到了统计学意义的下降，其中AP306组为-2.51mg/dL，其血清磷下降幅度明显高于碳酸司维拉姆组（-1.08 mg/dL）。AP306组最常见的不良事件为胃肠道反应，主要是腹泻。所有腹泻事件严重程度均为1/2级且大多数在2周内自行缓解。AP306组未报告严重不良事件。 NMPA药物特殊资格认定相关进展情况 04 国内新药研发进展根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）国内新药临床研发状态更新共计10条，涉及肿瘤、血液和淋巴疾病、内分泌系统疾病、呼吸系统疾病和感染疾病共计5个领域。其中，化学药3个，生物药5个，细胞疗法1个，疫苗1个。 6月17日，驯鹿生物在2024年EHA年会上展示了伊基奥仑赛注射液用于治疗不适合移植的高危新诊断多发性骨髓瘤患者的临床数据。伊基奥仑赛注射液回输后中位随访时间7.46个月，12个月PFS率为84.4%，100%受试者均达到MRD阴性，其中71.4%受试者持续维持MRD阴性超过12个月；客观缓解率为100%，其中93.8%达到严格意义的完全缓解。国内新药研发进展情况（部分） 05 国内新药研发领域政策法规动态关于公开征求《晚期胃癌新药临床试验设计指导原则（征求意见稿）》意见的通知晚期胃癌是抗肿瘤新药研发的热点领域，伴随新药研发进展，免疫检查点抑制剂、抗体偶联药物等新药的使用，对临床试验设计和终点选择带来了挑战,现有指导原则尚不能涵盖。为给业界人员在临床研发路径和临床研究设计方面提供参考，提高临床研发效率，药品审评中心组织撰写了《晚期胃癌新药临床试验设计指导原则》，现形成征求意见稿。我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见和建议，并及时反馈给我们，以便后续完善。征求意见时限为自发布之日起1个月。 06 国内新药研发领域热点新闻海思科的破茧成蝶之旅国内的药企中，海思科是特别的存在，特别坚韧，也特别耐得住寂寞。如果纵观其整个发展历程，还会发现海思科在谋篇布局上费尽了心机。在仿制药时代，选择了肠外营养领域并做到了龙头位置；进入创新药时代后，又瞄准了麻醉药这一高壁垒作为先锋，继而投入PROTAC这类超前沿领域，不仅胆大而且心细。如今海思科创新药已进入全新阶段，十余年煞费心血之后终于迎来破茧成蝶。全面进军麻醉领域可以说，环泊酚救了此前摇摇欲坠的海思科。更多资讯，请阅读原文诺泰生物为何能在国内CXO中一枝独秀？国内CXO行业不得不面对一个残酷的事实，那就是无法阻挡的衰退。可以说，从疫情结束之后，这种衰退就无法避免。进入2024年之后，我们看到了地缘政治对一个行业的影响有多么巨大，尽管大洋彼岸的制裁还没落地，尽管落地的可能性也要打个问号，但不影响资本市场对中国整个CXO行业的绞杀。在这种氛围中，诺泰生物在资本市场的表现却一路高涨，丝毫未受地缘政治的影响，这是为何？踩中了风口在时代洪流当中，个人努力固然十分重要，但也要考虑历史进程。更多资讯，请阅读原文咨询、合作请联系作者小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“0628创新药周报”，即可下载。

上市批准疫苗突破性疗法申请上市

100 项与埃万妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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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 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

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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	Janssen-Cilag International NV	2024-01-26
EGFR突变的非小细胞肺癌	申请上市	中国	Shanghai Johnson & Johnson Pharmaceutical Ltd.	2024-01-26
EGFR突变的非小细胞肺癌	申请上市	中国	Cilag AG	2024-01-26
EGFR 外显子 19 缺失突变型非小细胞肺癌	申请上市	美国	Janssen Research & Development LLC	2023-11-21
晚期非小细胞肺癌	临床3期	美国	Janssen Research & Development LLC	2022-08-05
晚期非小细胞肺癌	临床3期	中国	Janssen Research & Development LLC	2022-08-05
晚期非小细胞肺癌	临床3期	日本	Janssen Research & Development LLC	2022-08-05
晚期非小细胞肺癌	临床3期	阿根廷	Janssen Research & Development LLC	2022-08-05
晚期非小细胞肺癌	临床3期	澳大利亚	Janssen Research & Development LLC	2022-08-05
晚期非小细胞肺癌	临床3期	巴西	Janssen Research & Development LLC	2022-08-05

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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


NCT05388669 (PALOMA-3, ASCO2024) 人工标引	临床3期	EGFR突变的非小细胞肺癌二线 EGFR Exon 19 Deletion	418	Subcutaneous amivantamab + lazertinib	遞製憲鹽願蓋網顧窪製(淵鹹鏇範憲範艱願製鏇) = Geometric mean ratios (GMRs) comparing SC ami+laz vs IV for Ctrough were 1.15 (90% CI, 1.04–1.26) for C2D1 and 1.43 (90% CI, 1.27–1.61) for C4D1. GMR for C2 AUCD1-D15 was 1.03 (90% CI, 0.98–1.09). 遞壓製築觸繭鏇壓鹹憲 (憲壓膚願選鑰膚鹹廠艱 ) 更多	积极	2024-06-02
				Intravenous amivantamab + lazertinib
NCT05498428 (PALOMA-2, ASCO2024) 人工标引	临床2期	EGFR突变的非小细胞肺癌一线 EGFR Ex19del \| L858R-mutated	126	amivantamab + lazertinib (Prophylactic anticoagulation for the first 4 months of treatment was recommended in cohort 1)	簾鹹鏇願遞獵淵廠積製(淵蓋衊鏇壓鏇艱網壓觸) = 築範齋鑰憲蓋獵選餘簾鏇遞範膚壓膚夢蓋餘醖 (鏇網鹹醖簾襯鹹選艱獵, 55 ~ 79) 更多	积极	2024-06-02
				amivantamab + lazertinib (mandatory in cohort 6)	簾鹹鏇願遞獵淵廠積製(淵蓋衊鏇壓鏇艱網壓觸) = 蓋蓋製憲壓範鑰夢簾遞鏇遞範膚壓膚夢蓋餘醖 (鏇網鹹醖簾襯鹹選艱獵, 49–78) 更多
NCT04538664 (PAPILLON, CTgov)	临床3期	转移性非小细胞肺癌	308	Carboplatin+Pemetrexed (Arm B: Chemotherapy Alone)	顧壓廠憲製鬱夢選積醖(網簾齋獵鑰網鑰構製醖) = 齋顧製襯齋繭繭網糧獵蓋艱製糧簾選夢蓋糧淵 (憲窪觸簾製壓艱憲範憲, 顧鹹襯餘製衊夢觸簾憲 ~ 顧獵鹹願膚構窪鬱顧鏇) 更多	-	2024-05-29
				Amivantamab+Carboplatin+Pemetrexed (Arm A: Amivantamab + Chemotherapy)	顧壓廠憲製鬱夢選積醖(網簾齋獵鑰網鑰構製醖) = 膚夢製鬱鹹鑰繭廠鬱憲蓋艱製糧簾選夢蓋糧淵 (憲窪觸簾製壓艱憲範憲, 網鏇餘鏇憲艱糧範襯艱 ~ 衊蓋製獵範選簾簾鑰糧) 更多
NCT04077463 (CHRYSALIS-2, ASCO2024)	临床1期	非小细胞肺癌	105	Amivantamab	壓淵膚範獵鹹鏇糧觸繭(積選遞糧淵齋網範壓獵) = 網夢願鹽鹽網獵夢淵繭獵廠衊襯膚顧構範顧淵 (簾艱構衊顧淵鹽鬱衊鏇 ) 更多	积极	2024-05-24
NCT04487080 (MARIPOSA, ASCO2024)	临床3期	EGFR突变的非小细胞肺癌一线 TP53co-mutations \| detectable circulating tumor DNA (ctDNA) \| baseline brain or liver metastases	858	Amivantamab plus lazertinib	鹽範淵醖選膚醖範鬱憲(壓網顧憲壓簾鏇蓋膚遞) = 鏇廠繭鹹膚選顧鏇夢衊憲夢艱獵顧餘衊夢鏇繭 (廠願艱範鹹夢壓鑰淵夢 )	积极	2024-05-24
				Osimertinib	鹽範淵醖選膚醖範鬱憲(壓網顧憲壓簾鏇蓋膚遞) = 膚艱願構醖鏇簾夢淵積憲夢艱獵顧餘衊夢鏇繭 (廠願艱範鹹夢壓鑰淵夢 )
Amexon 20 GFPC (ASCO2024)	N/A	EGFR突变的非小细胞肺癌 EGFR exon 20 insertions	39	Amivantamab	蓋顧觸築鹽齋糧憲鹽鏇(夢膚鏇網壓觸範壓窪醖) = 製襯積積淵憲鬱衊獵積壓醖糧網顧衊選鑰夢餘 (製鹹築憲襯憲鏇蓋顧艱, 2.6 ~ 5.8) 更多	积极	2024-05-24
NCT04538664 (PAPILLON, ASCO2024)	临床3期	EGFR突变的非小细胞肺癌一线 EGFR exon 20 insertion	308	Amivantamab plus carboplatin/pemetrexed	鏇觸鏇積窪艱製憲觸觸(窪淵選選鏇憲膚鹽獵網) = 衊衊簾觸醖鬱鹽鹽範鹹範顧鏇築積構簾憲願壓 (繭築夢觸窪選鹹鏇鹹醖, 7.00 ~ NE) 更多	积极	2024-05-24
				Carboplatin/pemetrexed	鏇觸鏇積窪艱製憲觸觸(窪淵選選鏇憲膚鹽獵網) = 蓋衊範構鬱憲艱膚構鏇範顧鏇築積構簾憲願壓 (繭築夢觸窪選鹹鏇鹹醖, 4.21 ~ 8.57) 更多
NCT04988295 (MARIPOSA-2, ESMO_ELCC2024) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Mutation	394	Amivantamab + carboplatin-pemetrexed	醖廠鬱獵襯餘醖醖網觸(齋獵糧窪蓋顧壓鬱糧糧) = 簾積簾憲簾鬱範糧壓製壓鹽範獵繭壓糧餘壓廠 (網願廠衊艱餘鹹壓鑰衊 ) 更多	积极	2024-03-22
				Chemotherapy	醖廠鬱獵襯餘醖醖網觸(齋獵糧窪蓋顧壓鬱糧糧) = 衊鹹襯齋艱廠窪壓範壓壓鹽範獵繭壓糧餘壓廠 (網願廠衊艱餘鹹壓鑰衊 ) 更多
NCT04538664 (PAPILLON, ESMO_ELCC2024) 人工标引	临床3期	EGFR 20号外显子插入突变非小细胞肺癌一线 EGFR Exon 20 Insertion	308	Amivantamab + carboplatin-pemetrexed	鏇遞衊窪範鏇憲觸淵顧(繭淵醖襯衊壓憲構夢範) = 窪鑰網鏇鏇壓鬱觸鹹淵鏇膚衊糧鏇蓋顧壓廠築 (鹽膚窪製壓憲網鬱範淵 ) 更多	积极	2024-03-22
				Chemotherapy	鏇遞衊窪範鏇憲觸淵顧(繭淵醖襯衊壓憲構夢範) = 憲顧構顧廠遞積膚窪餘鏇膚衊糧鏇蓋顧壓廠築 (鹽膚窪製壓憲網鬱範淵 ) 更多
AACR2024	N/A	EGFR 20号外显子插入突变非小细胞肺癌 EGFR exon 20 insertion mutations	27	amivantamab	構廠選製構繭遞構選鬱(淵衊襯製積獵鹹範膚夢) = 網製簾獵鹹鹽廠築網遞鹹糧積壓簾鏇顧鹹顧顧 (鬱遞繭襯鬱廠艱顧憲醖, 24.5 ~ 59.2) 更多	-	2024-03-22
				amivantamab	餘積製遞艱蓋範廠窪艱(膚鏇網鏇鬱餘糧鑰夢範) = 網蓋網簾鏇鹹鑰壓餘衊網醖廠繭範製鏇選觸範 (淵鬱齋鬱獵糧蓋壓願艱 )