A Phase 2, Multicenter, Open-label, Non-controlled Study to Evaluate the Efficacy and Safety of Necitumumab in Patients with Unresectable, Advanced or Recurrent Esophageal Cancer or Gastric Cancer with EGFR Amplification (NEO-GEAR Study)

开始日期2025-01-24

申办/合作机构

Nippon Kayaku Co., Ltd.

JPRN-jRCT2021210079

/ Active, not recruiting临床1/2期

A Phase 1/2 Study of Necitumumab plus Osimertinib for Advanced Non-small Cell Lung Cancer with EGFR-mutation (NEO-FORCE study)

开始日期2022-03-09

申办/合作机构-

JPRN-jRCT2031210387

/ Active, not recruiting临床1/2期

A Phase I/II Study of necitumumab + carboplatin + nab-paclitaxel + pembrolizumab for previously untreated advanced squamous non-small cell lung cancer study (NEXUS)

开始日期2021-08-25

申办/合作机构-

100 项与奈妥木单抗相关的临床结果

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100 项与奈妥木单抗相关的转化医学

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100 项与奈妥木单抗相关的专利（医药）

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项与奈妥木单抗相关的文献（医药）

2025-06-01·JCO Precision Oncology

ORCHARD: Osimertinib Plus Necitumumab in Patients With Epidermal Growth Factor Receptor–Mutated Advanced Non–Small Cell Lung Cancer With a Secondary Epidermal Growth Factor Receptor Alteration Whose Disease Had Progressed on First-Line Osimertinib

Article

作者: Piotrowska, Zofia ; Ponce, Santiago ; Yu, Helena A. ; de Langen, Adrianus J. ; Ambrose, Helen ; Yoneshima, Yasuto ; Goldberg, Sarah B. ; Le, Xiuning ; Riess, Jonathan W. ; Cho, Byoung Chul ; Goldman, Jonathan W. ; Tang, Kwan Ho ; Lau, James ; Cavazzina, Riccardo

PURPOSE:

ORCHARD (ClinicalTrials.gov identifier: NCT03944772 ) is a phase II, biomarker-directed platform study designed to characterize resistance mechanisms and evaluate novel drug combinations in patients with epidermal growth factor receptor ( EGFR )–mutated advanced non–small cell lung cancer who have progressed on first-line osimertinib. We report final results of the module assessing the efficacy and safety of osimertinib plus necitumumab (a monoclonal antibody that blocks EGFR) in patients with ≥one of the following: EGFR amplification or select secondary EGFR alterations (L718 or G724 mutation, or exon 20 insertion).

MATERIALS AND METHODS:

Patients received osimertinib (80 mg orally once daily) plus necitumumab (800 mg intravenously, days 1 and 8 of a 3-week cycle) until disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR) per RECIST 1.1 by investigator assessment.

RESULTS:

Overall, 19 patients received osimertinib plus necitumumab; at data cutoff (April 18, 2023), all patients had discontinued treatment. The ORR was 11% (80% CI, 3 to 26); two patients had a confirmed partial response, with duration of response of 10.4 and 6.0 months; both patients had EGFR amplification. The median progression-free survival was 4.0 months (95% CI, 1.3 to 5.4) and the overall survival was 11.4 months (95% CI, 6.6 to 15.5). Ten patients (53%) had grade ≥3 adverse events, most commonly embolism (not otherwise specified, pulmonary embolism or deep vein thrombosis, reported in four patients; 21%). The safety profile of the combination was consistent with the known profiles of the two individual drugs, and no new signals were identified.

CONCLUSION:

Osimertinib plus necitumumab demonstrated modest clinical benefit, and the overall risk-benefit analysis indicates that further evaluation of the regimen is not warranted in these molecularly defined subsets of osimertinib resistance.

2025-03-01·IN VIVO

A Case of EGFR-mutant Squamous Cell Lung Cancer Treated With Necitumumab Combination Therapy

Article

作者: Nomura, Satoshi ; Inomata, Minehiko ; Takata, Naoki ; Furukawa, Daisuke ; Okazawa, Seisuke ; Imanishi, Shingo ; Tokui, Kotaro

BACKGROUND/AIM:

There is insufficient evidence regarding the optimal treatment for squamous cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations, and a standard treatment strategy has not been established.

CASE REPORT:

A 60-year-old woman was diagnosed with advanced EGFR-mutant squamous cell lung cancer. She was treated with EGFR tyrosine kinase inhibitors and then received the combined therapy of cytotoxic agents plus immune checkpoint inhibitors as third-line therapy. She was then treated with the fourth-line combination therapy of cisplatin, gemcitabine, and necitumumab, which resulted in a progression-free survival of 5.0 months and shrinkage of the liver metastatic lesion.

CONCLUSION:

The combination therapy of cisplatin, gemcitabine, and necitumumab was effective in treating pretreated EGFR-mutant squamous cell lung cancer in this case. It is necessary to accumulate more evidence to determine the most effective treatment for advanced EGFR-mutant squamous cell lung cancer.

2025-02-01·JTO clinical and research reports

Afatinib and Necitumumab in EGFR-Mutant NSCLC with Acquired Resistance to Tyrosine Kinase Inhibitors

Article

作者: Horn, Leora ; Wakelee, Heather A ; Iams, Wade T ; Reckamp, Karen L ; Myall, Nathaniel J ; Shyr, Yu ; Neal, Joel W ; Berry, Lynne D ; Padda, Sukhmani K ; Whisenant, Jennifer G ; York, Sally

Introduction:

Although tyrosine kinase inhibitors (TKIs) are effective against NSCLC harboring sensitizing EGFR gene mutations, acquired resistance is inevitable. Preclinical studies suggest that combining EGFR TKI and monoclonal antibody therapies may have activity in EGFR-mutated NSCLC that has progressed on TKI therapy alone. Therefore, we prospectively evaluated afatinib plus necitumumab in patients with EGFR-mutated NSCLC.

Methods:

This was a phase 1, dose-escalation, dose-expansion trial assessing the safety and efficacy of afatinib plus necitumumab. Patients had advanced or metastatic EGFR-mutated NSCLC with progression after (1) first-generation TKI if T790M negative, (2) subsequent line third-generation TKI if T790M positive, or (3) third-generation TKI in the first-line setting. Dose-escalation followed a 3+3 design. The primary end point of dose-expansion was objective response rate.

Results:

A total of 22 patients with EGFR-mutated NSCLC were enrolled. The maximum tolerated dose was afatinib 40 mg oral daily plus necitumumab 600 mg intravenous on days 1 and 15 every 28 days. There were no grade 4 to 5 adverse events observed, and seven patients (32%) experienced grade 3 treatment-related adverse events (three rash; one each oral mucositis, diarrhea, headache, ventricular arrhythmia, and tachycardia). In the entire cohort, there were no responses observed, the median progression-free survival was 1.8 months, and the disease control rate was 36% but varied between the subgroups.

Conclusions:

Afatinib plus necitumumab was safe but had limited activity in patients with EGFR-mutated NSCLC. Biomarker studies may identify patient subgroups that are more likely to benefit.

项与奈妥木单抗相关的新闻（医药）

2026-05-28

·henlius.com

复宏汉霖PD-L1 ADC HLX43后线晚期sqNSCLC国际多中心II/III期研究完成中国首例患者给药，全球开发加速推进

2026年5月28日，复宏汉霖（2696.HK）宣布，公司创新抗PD-L1抗体偶联药物（ADC）HLX43用于既往治疗失败的晚期/转移性鳞状非小细胞肺癌(sqNSCLC)治疗的II/III期国际多中心临床研究（HLX43-NSCLC302）已在中国完成首例患者给药，标志着该研究在中国正式进入临床实施阶段。近期，该研究也已获得日本药品医疗器械综合机构（PMDA）默示许可，将于中国、美国、日本等多国开展，其III期研究阶段有望成为HLX43首个、同时也是其在非小细胞肺癌领域的关键注册临床研究，为既往标准治疗失败后的sqNSCLC患者这一难治群体带来新的治疗选择。肺癌是全球发病率和死亡率最高的癌症，2022年全球约有超过248万新发肺癌病例1。其中，非小细胞肺癌（NSCLC）是最常见的肺癌类型（约85%），可分为鳞状细胞癌（约30%）、肺腺癌（约50%）等，且鳞状NSCLC通常预后更差2。尽管以抗PD-1/L1单抗为代表的免疫检查点抑制剂联合化疗显著改善了晚期或转移性鳞状NSCLC患者的生存率。但在病情进展的2线或以上的后线人群治疗上，疗效优异的产品较少，主要依赖于多西他赛为基础的化疗方案，存在较大的未被满足的临床需求3-4。近年来，抗体偶联药物（ADC）在肿瘤治疗中已展现出卓越的临床疗效，并在后线鳞状NSCLC的临床探索中显示了积极信号5-6。同时，抗EGFR单抗联合化疗在鳞状NSCLC治疗中取得一定进展7-9，但疗效多集中于EGFR高表达人群。抗EGFR单抗联合新型治疗方案在EGFR低表达患者中的疗效亟待进一步探索。 HLX43是一款潜在同类最优的广谱抗肿瘤PD-L1 ADC，兼具免疫检查点阻断与载荷细胞毒性的双重作用机制。目前，HLX43在NSCLC等实体瘤中展现出“高效、低毒”的初步临床疗效。根据2026年美国临床肿瘤学会（ASCO）年会公布的HLX43单药治疗NSCLC研究的摘要，在161名可评估疗效的患者中（各剂量组分别为1 mg/kg 2人、2 mg/kg 69人、2.5 mg/kg 64人、3 mg/kg21人、4 mg/kg 5人），研究者评估的客观缓解率（ORR）为31.1%。其中，在EGFR野生型非鳞状NSCLC患者中（n=19），HLX43已展现出初步的临床优势，ORR达47.4%。针对既往多西他赛失败的患者（n=15），ORR仍达到40.0%。生物标志物探索分析显示，疗效与PD-L1表达无明显相关，PD-L1阳性（n=83）和PD-L1阴性（n=78）患者的ORR分别为30.1%和32.1%。总体上，199名患者（97.1%）出现治疗相关不良事件（TRAEs），其中88名（42.9%）为≥3级。最常见的≥3级TRAEs（发生率≥10%）包括淋巴细胞计数降低（n=47，22.9%）、白细胞计数降低（n=27，13.2%）、贫血（n=25，12.2%）和中性粒细胞计数降低（n=23，11.2%）。因TRAEs导致停药的患者为17人（8.3%）。完整数据将于美国中部时间5月30日下午以快速口头报告的形式正式发布。值得注意的是，本次发布将首次披露亚组无进展生存期（PFS）数据，以进一步确证HLX43单药在后线难治性NSCLC治疗中的临床应用潜力与价值。 Pimurutamab是复宏汉霖自主研发的一款抗EGFR单克隆抗体，具备更低的免疫原性和更优的EGFR靶点亲和力。同时通过Fc端改造，显著延长其半衰期，3周的给药频率使其更适合与肿瘤免疫产品的临床联用。临床前研究表明，pimurutamab相较同类抗EGFR单抗具有更出色的生物活性，在不同肿瘤模型中均能显著抑制肿瘤细胞的生长。因此，HLX43有望协同抗EGFR单抗pimurutamab，发挥出较HLX43单药及抗EGFR单抗联合化疗更高的治疗潜力，进一步提升鳞状NSCLC等晚期实体瘤患者的治疗获益。目前，复宏汉霖正全力推进HLX43的临床开发进程，在全球入组超过700例患者。其中NSCLC患者占比超过60%（400例），包括一项针对NSCLC的国际多中心II期临床研究（HLX43-NSCLC201）正在中、美、日、澳等地同步开展。此外，公司已累计开展十余项HLX43单药或联合其他产品的临床研究，广泛覆盖宫颈癌（CC）、食管鳞癌（ESCC）、头颈鳞癌（HNSCC）、鼻咽癌（NPC）、结直肠癌（mCRC）、胃癌/胃食管交界部（G/GEJ）癌、胰腺导管腺癌（PDAC）、乳腺癌（BC）等，持续探索和挖掘HLX43在实体瘤中的广谱治疗潜力，其在CC、ESCC、NPC、HNSCC等肿瘤中的概念验证（PoC）研究数据已在/将在ESMO Asia、ASCO GI、ASCO、ESMO等大会上陆续读出。单药之外，基于HLX43展现出的IO疗效，公司积极探索HLX43与其他多元分子如公司自研创新抗EGFR单抗pimurutamab、H药汉斯状®（斯鲁利单抗，抗PD-1单抗）的联合治疗潜力，不断挖掘和最大化该产品在临床中的应用价值。关于HLX43-NSCLC302研究 HLX43-NSCLC302研究为一项随机、开放标签、国际多中心II/III期临床研究，旨在评估HLX43单药或HLX43联合公司自主研发的重组抗EGFR单克隆抗体pimurutamab（HLX07），相较于多西他赛，在既往治疗失败的晚期/转移性sqNSCLC患者中的疗效和安全性。研究包括两个阶段：第一阶段为一项开放标签、随机、多中心的2期研究，合格的受试者将按照1:1:1:1的比例随机分配至A组（HLX43单药）、B组（HLX43联合pimurutamab，1,000 mg）、C组（HLX43联合pimurutamab，600 mg）或D组（多西他赛）；第二阶段为一项开放标签、随机、多中心的3期研究，将根据第一阶段结果选定 HLX43单药或HLX43联合pimurutamab作为试验组方案，合格的受试者将按照1:1的比例随机分配至试验组（HLX43单药或HLX43联合pimurutamab）或对照组（多西他赛）。本研究的主要目是评估HLX43单药或HLX43联合pimurutamab对比多西他赛在经一线治疗失败的晚期sqNSCLC患者中的临床疗效，采用总生存期（OS）和无进展生存期（PFS）作为双主要终点。次要目的包括评价HLX43单药或HLX43联合pimurutamab对比多西他赛的安全性、HLX43和pimurutamab的药代动力学（PK）特征、免疫原性，以及探索潜在的预测性或耐药性生物标志物。参考文献 References 1.Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. 2.Wang, Y., et al. Immunotherapy for advanced-stage squamous cell lung cancer: the state of the art and outstanding questions. Nat Rev Clin Oncol 22, 200–214 (2025). 3.中国临床肿瘤学会中国临床肿瘤学会(CSCO). (2024)非小细胞肺癌诊疗指南 4.NCCN Guidelines Version 3. 2025, Non-Small Cell Lung Cancer. 5.Ahn MJ, et al. TROPION-Lung01 Trial Investigators. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. 2025 Jan 20;43(3):260-272. 6.Paz-Ares LG, et al. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. 2024 Aug 20;42(24):2860-2872. 7.Pirker R, et al. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol. 2012 Jan;13(1):33-42.8. 8.Thatcher N, et al. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. 9.Becotatug (JMT101, Beco) combined with docetaxel (albumin-bound, HB1801) for the treatment of patients (pts) with locally advanced squamous cell non-small cell lung cancer (sqNSCLC): A randomized control phase II study (BATTLE study). ESMO Asia 2025|2025-12-05.

抗体药物偶联物ASCO会议临床结果临床3期申请上市

2026-05-26

·BioSpace

Verastem Oncology Appoints Michael P. Bailey to its Board of Directors

BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced the appointment of Michael P. Bailey to its Board of Directors. The Company also announced that Robert Gagnon stepped down from the Board following the end of his term on May 21, 2026. “We are excited to have Michael join our Board as he brings more than three decades of experience leading global pharmaceutical and biotechnology companies, with a proven track record of taking oncology medicines from clinical development through successful commercialization, including landmark therapies like ERBITUX®,” said Daniel Paterson, president and chief executive officer of Verastem Oncology. “We look forward to drawing on the insight and expertise Michael brings as we enter the next phase of growth for AVMAPKI® FAKZYNJA® CO-PACK and advance the development of VS-7375, our potential best-in-class oral KRAS G12D (ON/OFF) inhibitor.” “Michael is an accomplished biopharmaceutical executive with deep expertise across the full product lifecycle. Michael’s perspective will be an asset to our Board as Verastem advances its innovative pipeline and builds on its commercial success,” said John Johnson, chairman of Verastem’s Board of Directors. “We’d also like to thank Robert for his dedicated service and the contributions he made during his tenure.” Mr. Bailey added, “I am honored to join Verastem’s Board of Directors at such a pivotal time for the company. Verastem has built a strong business for an underserved rare cancer patient population, and with VS-7375, the company has the potential to make a significant difference in the lives of patients living with KRAS G12D-mutated cancers where there are currently no approved therapies. I look forward to supporting the team and contributing to the company’s continued growth.” Michael P. Bailey Mr. Bailey currently serves as president and chief executive officer (CEO) of AVEO Pharmaceuticals, Inc. (AVEO), an LG Chem, Ltd. Company, and has served on its Board since January 2015, having previously held the roles of chief business officer and chief commercial officer at AVEO. In 2023, Mr. Bailey led the acquisition of AVEO by LG Chem, Ltd. Before AVEO, he was senior vice president of business development and chief commercial officer at Synta Pharmaceuticals Corp. Earlier, Mr. Bailey spent nine years at ImClone Systems Inc., where he led commercial planning and the launch of ERBITUX® (cetuximab) across multiple oncology indications, drove new product planning for CYRAMZA® (ramucirumab) and PORTRAZZA® (necitumumab) and rose to senior vice president of commercial operations. Prior to ImClone, Mr. Bailey managed the cardiovascular new products development portfolio at Genentech. Mr. Bailey started his career as part of SmithKline Beecham’s executive marketing development program, where he held a variety of commercial roles, including sales, strategic planning and product management. Mr. Bailey received a B.S. in psychology from St. Lawrence University and an M.B.A. in international marketing from Mendoza College of Business at University of Notre Dame and continued his executive education in Finance at Harvard Business School and Board of Director Leadership at Wharton School of Business. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI® FAKZYNJA® CO-PACK in the U.S. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition , FAK inhibition , and KRAS G12D inhibition . For more information, please visit and follow us on LinkedIn . Contacts For Investor and Media Inquiries: Julissa Viana Senior Vice President, Corporate Communications, Investor Relations & Patient Advocacy investors@verastem.com or media@verastem.com

高管变更

2026-05-24

·分子药讯

ASCO 2026 重磅来袭！

2026年美国临床肿瘤学会（ASCO)年会将于2026年5月29日-6月2日在美国伊利诺伊州芝加哥举行。目前ASCO 2026的abstract和poster均可查看，现挑选poster中的肺癌中的部分内容进行分享，其他感兴趣的大家可以自行查看。 1. Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)─directed antibody-drug conjugate (ADC), plus pembrolizumab: Updated results from the phase 1 study (SGNB6A-001).Sigvotatug vedotin (SV，辉瑞制药)，一种在研的整合素β6（IB6）靶向抗体偶联药物（ADC），联合帕博利珠单抗：1期研究（SGNB6A-001）的更新结果。2. Dose-escalation results from a phase I study of FZ-AD004, a TROP2-directed ADC, in patients with advanced solid tumors.FZ-AD004（一种TROP2靶向ADC，复旦张江）在晚期实体瘤患者中I期研究的剂量递增结果。3. SHR-1826, a c-MET directed antibody-drug conjugate (ADC), in advanced solid tumors: Updates from a phase 1 study.SHR-1826（恒瑞医药），一种针对c-MET的抗体偶联药物（ADC），用于晚期实体瘤：一项1期研究的最新进展。4. SHR-A2102 in combination with adebrelimab as first-line treatment in patients with locally advanced or metastatic squamous or non-squamous non-small cell lung cancer (NSCLC): Results from a phase 1b/2 study.SHR-A2102（Nectin-4 ADC，恒瑞医药）联合adebrelimab（PD-L1单克隆抗体）作为局部晚期或转移性鳞状或非鳞状非小细胞肺癌（NSCLC）患者的一线治疗：一项1b/2期研究的结果。5. Necitumumab plus pembrolizumab and chemotherapy for untreated advanced squamous NSCLC: Phase I/II NEJ048A/NEXUS.Necitumumab（EGFR拮抗剂，礼来制药）联合帕博利珠单抗及化疗用于未经治疗的晚期鳞状非小细胞肺癌：I/II期NEJ048A/NEXUS研究。6. First-in-human study of DM005, an anti-EGFR/c-MET bispecific antibody-drug conjugate, in patients with advanced solid tumors.DM005（一种抗EGFR/c-MET双特异性抗体偶联药物，多玛医药）在晚期实体瘤患者中的首次人体研究。7. Comparing becotarug plus osimertinib with a real-world osimertinib therapy cohort in platinum-refractory, advanced non–small cell lung cancer with EGFR exon 20 insertion.在铂类耐药、EGFR 20外显子插入的晚期非小细胞肺癌中，比较becotarug（EGFR单克隆抗体，石药集团）联合奥希替尼与真实世界奥希替尼治疗队列的效果。8. Combination of golidocitinib (a JAK1 inhibitor) with anti–PD-1 antibody to improve tumor response and patient quality of life: Preliminary results from an ongoing JACKPOT 33 study.golidocitinib（一种JAK1抑制剂，迪哲医药）联合抗PD-1抗体改善肿瘤反应和患者生活质量：一项正在进行的JACKPOT 33研究的初步结果。9. Safety and efficacy of CS2009, a first-in-class PD-1/VEGF/CTLA-4 trispecific antibody, in patients with advanced non-small cell lung cancer: Results from a phase 1/2 study.CS2009（一种首创的PD-1/VEGF/CTLA-4三特异性抗体，基石药业）在晚期非小细胞肺癌患者中的安全性和有效性：一项1/2期研究的结果。10. Efficacy, safety, and cytokine profiling with addition of the toll-like receptor (TLR) 7/8 dual agonist EIK1001 to standard of care (SOC) first-line (1L) therapy: The phase 2 TeLuRide-005 trial in stage 4 NSCLC.在标准治疗（SOC）一线（1L）疗法中加入Toll样受体（TLR）7/8双激动剂EIK1001（Eikon Therapeutics）的疗效、安全性和细胞因子谱分析：4期非小细胞肺癌（NSCLC）的2期TeLuRide-005试验。11. SHR-1701 combined with fuzuloparib and chemotherapy as first-line therapy for advanced lung squamous cell carcinoma: Efficacy and safety results from a phase II study.SHR-1701（PD-L1/TGF-βRⅡ双特异性抗体融合蛋白，恒瑞医药）联合富唑帕利和化疗作为晚期肺鳞状细胞癌的一线治疗：一项II期研究的有效性和安全性结果。12. 1L olomorasib plus pembrolizumab +/- chemotherapy in KRAS G12C-mutant NSCLC patients +/- a prior cycle of SOC: Results from LOXO-RAS 20001 and SUNRAY-01.1L olomorasib（第二代KRAS G12C抑制剂，礼来制药）联合 pembrolizumab +/- 化疗用于 KRAS G12C 突变 NSCLC 患者 +/- 既往标准治疗：LOXO-RAS 20001 和 SUNRAY-01 的结果。13. A phase II study of HB0025 (a PD-L1/VEGF bispecific antibody) in combination with chemotherapy as first-line treatment for non–small cell lung cancer (NSCLC).HB0025（一种PD-L1/VEGF双特异性抗体，华海药业）联合化疗作为非小细胞肺癌（NSCLC）一线治疗的II期研究。14. Initial safety and efficacy of A2B694, a logic-gated mesothelin (MSLN)–targeted Tmod chimeric antigen receptor T-cell (CAR T) therapy in patients with advanced solid tumors with HLA-A*02 loss of heterozygosity (LOH).A2B694（A2 Biotherapeutics, Inc.）在HLA-A*02杂合性丢失（LOH）的晚期实体瘤患者中，作为一种逻辑门控间皮素（MSLN）靶向Tmod嵌合抗原受体T细胞（CAR T）疗法的初步安全性和有效性。15. Phase I study of IMM2510, a PD-L1/ VEGF bispecific antibody, in participants with advanced IO-treated SQ-NSCLC.IMM2510（一种PD-L1/VEGF双特异性抗体，宜明昂科）在接受过免疫治疗的晚期鳞状非小细胞肺癌患者中的I期研究。16. IBI363 (TAK-928) plus chemotherapy as first-line (1L) treatment for advanced non–small cell lung cancer (NSCLC).IBI363 (TAK-928，PD-1/IL-2α-bias双特异性抗体融合蛋白，信达生物) 联合化疗作为晚期非小细胞肺癌 (NSCLC) 的一线 (1L) 治疗。17. Resistance mechanisms and efficacy of first-line alectinib and sequential treatments in advanced ALK+ NSCLC: Real-world outcomes from a multicenter, observational study in Japan (ALCURE).晚期ALK+ NSCLC一线阿来替尼（罗氏制药）及后续治疗的耐药机制与疗效：日本多中心观察性研究（ALCURE）的真实世界结果。18. Afatinib versus osimertinib for non–small cell lung cancer with uncommon epidermal growth factor receptor mutations: Real-world outcomes (HOT-Next001/HOT2501).阿法替尼（德国勃林格殷格翰公司）与奥希替尼治疗罕见表皮生长因子受体突变的非小细胞肺癌：真实世界结果（HOT-Next001/HOT2501）。19. Brigatinib after lorlatinib and/or chemotherapy following first-line alectinib in ALK-rearranged NSCLC: Cohort B of the WJOG11919L/ABRAID study.在ALK重排非小细胞肺癌中，一线阿来替尼治疗后使用洛拉替尼（辉瑞制药）和/或化疗，随后使用布格替尼：WJOG11919L/ABRAID研究的B组。20. High-dose furmonertinib in EGFR-mutated advanced NSCLC with brain metastases after EGFR-TKI resistance: The iFORCE phase II trial.高剂量伏美替尼（第三代EGFR-TKI靶向药，上海艾力斯）治疗EGFR突变晚期非小细胞肺癌脑转移患者（EGFR-TKI耐药后）：iFORCE II期临床试验。21. Sotorasib vs adagrasib in the 2L+ setting: Outcomes in a large, multi-institutional, real-world database of KRAS-G12C mutated mNSCLC.索托拉西布（安进制药）与阿达格拉西布（Mirati Therapeutics（现已被BMS收购））在二线及以上治疗中的对比：基于KRAS-G12C突变转移性非小细胞肺癌的大型多中心真实世界数据库的结局分析。22. Profiling patients with MET exon 14 (METex14) skipping NSCLC with a sustained clinical benefit to tepotinib in VISION.VISION研究中对MET外显子14（MET ex14）跳跃非小细胞肺癌患者进行特征分析，以评估其对特泊替尼（一种口服MET酪氨酸激酶抑制剂，日本武田制药）的持续临床获益。23. COPERNICUS, a pragmatic phase 2b study of first-line (1L) subcutaneous (SC) amivantamab (ami) + lazertinib (laz) with supportive care in EGFR-mutated advanced NSCLC: Early safety results.COPERNICUS，一项关于一线（1L）皮下（SC）amivantamab（ami）+ lazertinib（laz，第三代EGFR-TKI，韩国柳韩洋行）联合支持治疗用于EGFR突变晚期NSCLC的实用性2b期研究：早期安全性结果。24. Safety and efficacy of APS03118, a next-generation RET inhibitor, in patients with non-small cell lung cancer (NSCLC): Results from a phase I clinical trial.下一代RET抑制剂APS03118（志健金瑞）在非小细胞肺癌（NSCLC）患者中的安全性和有效性：I期临床试验结果。25. Efficacy and safety of larotrectinib in patients with TRK fusion lung cancer: An updated analysis.拉罗替尼（Loxo Oncology（后被礼来收购））治疗TRK融合肺癌患者的疗效与安全性：一项更新分析。26. First-in-human dose-escalation study of the selective EGFR/HER2 exon 20 inhibitor PFL-721 in patients with locally advanced or metastatic NSCLC.选择性EGFR/HER2外显子20抑制剂PFL-721（EGFR抑制剂，Pierre Fabre Laboratories）在局部晚期或转移性非小细胞肺癌患者中的首次人体剂量递增研究。27. Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in previously treated patients with non-small cell lung cancer with non-classical and C797S EGFR mutations.silevertinib (BDTX-1535，四代EGFR TKI，Black Diamond Therapeutics, Inc.) 在既往接受过治疗的非经典和 C797S EGFR 突变非小细胞肺癌患者中 2 期研究的安全性和有效性结果。28. SOHO-01: Updated safety and efficacy of sevabertinib in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC).SOHO-01：更新的sevabertinib（HER2靶点抑制剂，拜耳医药）在晚期HER2突变非小细胞肺癌（NSCLC）患者中的安全性和有效性。29. Safety and antitumor activity of VRN110755, a brain-penetrant, selective EGFR inhibitor, in patients with EGFR-driven non–small cell lung cancer.VRN110755（一种可穿透血脑屏障的选择性EGFR抑制剂，Voronoi, Inc.）在EGFR驱动的非小细胞肺癌患者中的安全性和抗肿瘤活性。30. Efficacy and safety of deulorlatinib (TGRX-326) in patients with locally advanced or metastatic ALK+ non–small cell lung cancer: A multicenter, open-label, pivotal phase 2 trial.deulorlatinib (TGRX-326，ALK/ROS1抑制剂，深圳市塔吉瑞生物医药有限公司) 在局部晚期或转移性 ALK+ 非小细胞肺癌患者中的有效性和安全性：一项多中心、开放标签、关键性 2 期试验。31. Clinical efficacy and tolerability of the selective RET inhibitor soxataltinib (SY-5007) in advanced RET fusion–positive non–small cell lung cancer (NSCLC): Primary findings from a confirmatory phase III trial.选择性RET抑制剂soxataltinib（SY-5007，首药控股）在晚期RET融合阳性非小细胞肺癌（NSCLC）中的临床疗效与耐受性：一项确证性III期试验的主要结果。32. Results from OCEAN II: A phase II study of encorafenib + binimetinib combination in Chinese patients with BRAFV600E mutated metastatic non-small cell lung cancer.OCEAN II研究结果：一项关于中国BRAF突变转移性非小细胞肺癌患者接受encorafenib + binimetinib（BRAF+MEK）联合治疗的II期研究。33. A phase 2 multicenter, open-label, parallel cohort study to evaluate the efficacy, safety, and pharmacokinetic profile of ABN401 in patients with advanced solid tumors harboring c-MET dysregulation.一项2期多中心、开放标签、平行队列研究，旨在评估ABN401（c-MET抑制剂，Abion Inc.）在携带c-MET失调的晚期实体瘤患者中的疗效、安全性和药代动力学特征。34. A phase Ib study of osimertinib and tegavivint as first-line therapy in patients with metastatic EGFR-mutated non–small cell lung cancer (NSCLC).奥希替尼和特加维汀（TBL1拮抗剂，美国Iterion Therapeutics公司）作为转移性EGFR突变非小细胞肺癌（NSCLC）患者一线治疗的Ib期研究。35. Combination of tulmimetostat and PD-1 blockade for patients with advanced non–small cell lung cancer who progressed from first or second line of treatments.图尔米司他（EZH1/EZH2抑制剂，诺华制药）与PD-1阻断剂联合用于一线或二线治疗进展的晚期非小细胞肺癌患者。36. First-in-human phase I, open-label, multicenter study of HJ-004, a novel EGFR-PROTAC degrader, in patients with advanced EGFR-mutated non–small cell lung cancer.HJ-004（一种新型EGFR-PROTAC降解剂，和径医药科技（上海）有限公司）在晚期EGFR突变非小细胞肺癌患者中的首次人体I期、开放标签、多中心研究。37. KEYMAKER-U01J: Calderasib plus pembrolizumab with or without cetuximab as first-line treatment for advanced or metastatic nonsquamous non–small-cell lung cancer (NSCLC) with KRAS G12C mutations.KEYMAKER-U01J：卡尔德拉西布（KRAS G12C抑制剂，默沙东医药）联合帕博利珠单抗，联合或不联合西妥昔单抗，作为携带KRAS G12C突变的晚期或转移性非鳞状非小细胞肺癌（NSCLC）的一线治疗。38. An ongoing phase 1–2a study of EO1001, an oral brain-penetrant pan-ErbB inhibitor, in patients with advanced ErbB-driven solid tumors including CNS disease.一项正在进行的1-2a期研究，评估口服脑渗透性泛ErbB抑制剂EO1001（EGFR/HER2/HER4抑制剂，Edison Oncology Holding Corp.）在包括中枢神经系统疾病在内的晚期ErbB驱动型实体瘤患者中的疗效。

100 项与奈妥木单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10018	奈妥木单抗	L01XC22	DB09559

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
鳞状非小细胞肺癌	加拿大	Eli Lilly Canada, Inc.	2017-03-16
EGFR阳性非小细胞肺癌	欧盟	Eli Lilly Nederland BV	2016-02-15
EGFR阳性非小细胞肺癌	冰岛	Eli Lilly Nederland BV	2016-02-15
EGFR阳性非小细胞肺癌	列支敦士登	Eli Lilly Nederland BV	2016-02-15
EGFR阳性非小细胞肺癌	挪威	Eli Lilly Nederland BV	2016-02-15
非小细胞肺癌	美国	Eli Lilly & Co.	2015-11-24
非鳞状非小细胞肺癌	美国	Eli Lilly & Co.	2015-11-24

未上市

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期非小细胞肺癌	临床3期	美国	Eli Lilly & Co.	2010-01-07
局部晚期非小细胞肺癌	临床3期	澳大利亚	Eli Lilly & Co.	2010-01-07
局部晚期非小细胞肺癌	临床3期	奥地利	Eli Lilly & Co.	2010-01-07
局部晚期非小细胞肺癌	临床3期	比利时	Eli Lilly & Co.	2010-01-07
局部晚期非小细胞肺癌	临床3期	巴西	Eli Lilly & Co.	2010-01-07
局部晚期非小细胞肺癌	临床3期	加拿大	Eli Lilly & Co.	2010-01-07
局部晚期非小细胞肺癌	临床3期	克罗地亚	Eli Lilly & Co.	2010-01-07
局部晚期非小细胞肺癌	临床3期	法国	Eli Lilly & Co.	2010-01-07
局部晚期非小细胞肺癌	临床3期	德国	Eli Lilly & Co.	2010-01-07
局部晚期非小细胞肺癌	临床3期	希腊	Eli Lilly & Co.	2010-01-07

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临床结果

适应症

分期

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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


JPRN-jRCT2031200248 (K-TAIL-202, ASCO2026)	临床2期	PD-L1阳性肺癌一线 PD-L1-high	50	Pembrolizumab 200 mg IVNecitumumab 800 mg IV + Pembrolizumab 200 mg IVNecitumumab 800 mg IVIV (PD-L1 TPS ≥50% + Advanced NSCLC)	壓鹽顧網繭築簾網積願(鏇繭醖淵廠獵壓餘鬱繭) = 膚鹽醖願鹹餘憲餘鏇築淵鬱積鑰淵築積製觸網 (遞醖壓簾壓醖鏇範壓積, 53.3 ~ 80.5) 更多	积极	2026-05-29
JPRN-jRCTs041220070 (WJOG15021M, ESMO2025)	临床2期	EGFR 突变实体瘤 EGFR amplification	22	Necitumumab	壓繭觸鹽繭夢選壓蓋淵(簾廠鏇製蓋膚顧蓋襯淵) = 醖壓齋鬱願廠蓋淵範廠遞繭鹽繭衊鑰襯觸淵網 (蓋範憲膚膚窪鑰網窪夢, 9.6 ~ 37.8) 更多	不佳	2025-10-17
JPRN-jRCTs041220070 (WJOG15021M, ESMO2025)	临床2期	EGFR 突变实体瘤 EGFR amplification	22	Necitumumab (ESCC)	壓繭觸鹽繭夢選壓蓋淵(簾廠鏇製蓋膚顧蓋襯淵) = 獵窪簾夢窪艱製糧齋蓋遞繭鹽繭衊鑰襯觸淵網 (蓋範憲膚膚窪鑰網窪夢 )	不佳	2025-10-17
JPRN-jRCTs051200138 (WJOG14120L NESSIE, ESMO2024) 人工标引	临床2期	晚期鳞状细胞肺癌	46	Cisplatin and gemcitabine plus necitumumab (CGN)	齋衊膚鑰夢獵壓範夢鑰(鏇選襯膚淵觸鏇衊網蓋) = 鹽廠醖願齋襯夢憲構醖繭顧觸構製襯窪糧廠鏇 (廠憲壓鏇廠衊構廠齋蓋, 17.7 ~ 36.2) 更多	积极	2024-09-14
JPRN-jRCT2031200248 (K-TAIL-202, AACR2024) 人工标引	临床2期	PD-L1阳性非小细胞肺癌一线 PD-L1 Expression	50	Pembrolizumab anNecitumumabab	醖鏇願選憲願構蓋構積(構鑰遞簾構鬱艱構簾鏇) = 壓築網鏇壓蓋鹹憲醖糧壓鏇夢選積醖襯鬱壓窪 (遞餘觸糧齋築膚窪餘淵, 61.9 ~ 86.9) 更多	积极	2024-04-05
NCT02789345 (JVDL, CTgov)	临床1期	EGFR-T790M 突变非小细胞肺癌	29	Ramucirumab+Osimertinib (Arm A: Ramucirumab + Osimertinib)	製餘夢膚壓蓋鹽簾鏇選 = 鏇襯壓餘蓋選廠夢齋餘願廠鹹鏇鏇願廠願憲積 (憲憲艱鬱糧鏇鑰網憲願, 獵遞築願積憲廠窪獵構 ~ 簾鹽製鑰觸築夢夢醖餘) 更多	-	2024-02-05
NCT02789345 (JVDL, CTgov)	临床1期	EGFR-T790M 突变非小细胞肺癌	29	Osimertinib+Necitumumab (Arm B: Necitumumab + Osimertinib)	製餘夢膚壓蓋鹽簾鏇選 = 鑰窪鏇獵憲鹹選積鬱窪願廠鹹鏇鏇願廠願憲積 (憲憲艱鬱糧鏇鑰網憲願, 襯膚憲憲艱夢憲選鏇艱 ~ 醖鹽觸構觸鬱積糧構艱) 更多	-	2024-02-05
NCT04285671 (UCLA L-08, ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	难治性肺癌 EGFR Mutation	22	Necitumumab+Osimertinib+Trastuzumab	鑰憲築鬱製襯積構鏇願(糧憲簾廠製顧積憲觸廠) = 構窪憲衊衊壓鹹夢繭繭築積襯襯窪繭製繭鹹淵 (蓋願鹽窪獵網顧衊醖淵 ) 更多	积极	2023-05-31
NCT02443337 (CTgov)	临床2期	鳞状细胞肺癌 \| 转移性非小细胞肺癌 \| 转移性非鳞状非小细胞肺癌	31	LY3023414+Necitumumab (Lead in Cohort LY3023414 + Necitumumab)	遞衊壓廠蓋衊簾鹽鹽衊 = 襯膚繭窪廠簾觸醖顧衊壓製醖顧繭顧夢簾壓鬱 (積衊鑰窪簾獵觸艱糧鏇, 構糧壓齋壓願網憲範壓 ~ 觸遞觸餘繭願蓋繭網餘) 更多	-	2020-12-09
NCT02443337 (CTgov)	临床2期	鳞状细胞肺癌 \| 转移性非小细胞肺癌 \| 转移性非鳞状非小细胞肺癌	31	LY3023414+Necitumumab (Post Lead in Cohort LY3023414 + Necitumumab)	遞衊壓廠蓋衊簾鹽鹽衊 = 積築糧積觸窪遞齋構積壓製醖顧繭顧夢簾壓鬱 (積衊鑰窪簾獵觸艱糧鏇, 選願網襯鑰廠製夢鏇繭 ~ 積鹽壓糧製願艱鹽艱築) 更多	-	2020-12-09
NCT02451930 (CTgov)	临床1期	转移性非小细胞肺癌	71	Neci+Pembro (Part A Cohort 1: 600 mg Neci + 200 mg Pembro)	壓鏇鹽遞範窪簾醖獵襯 = 遞築膚鹽淵壓築網鏇鹽顧製鏇鬱鑰窪鑰鏇醖醖 (遞襯獵繭鑰顧鏇醖選蓋, 壓壓觸廠淵遞膚鹽獵選 ~ 鏇窪蓋糧憲製願範構網) 更多	-	2020-10-05
NCT02451930 (CTgov)	临床1期	转移性非小细胞肺癌	71	Neci+Pembro (Part A Cohort 2: 800 mg Neci + 200 mg Pembro)	壓鏇鹽遞範窪簾醖獵襯 = 廠願鏇憲範築餘選簾襯顧製鏇鬱鑰窪鑰鏇醖醖 (遞襯獵繭鑰顧鏇醖選蓋, 遞襯鑰網衊窪鑰窪糧鹹 ~ 製網夢獵夢膚蓋夢選顧) 更多	-	2020-10-05
NCT03574818 (CTgov)	临床2期	鳞状细胞肺癌	1	Evaluation to determine if patient is a candidate to proceeed with surgical resection or not+Gemcitabine+Cisplatin+necitumumab	觸選築衊鬱積衊壓選膚 = 憲糧鬱構襯鹹遞鬱積艱願餘遞廠鏇衊獵鑰衊壓 (鬱憲夢夢餘醖膚製築網, 選夢廠願顧觸製範壓憲 ~ 鏇醖遞餘餘蓋醖顧積衊) 更多	-	2020-02-18
NCT00981058 (SQUIRE, Pubmed \| Lung Cancer) 人工标引	临床2期	鳞状非小细胞肺癌一线	54	Necitumumab+nab-paclitaxel+carboplatin	簾襯衊廠鹽繭憲鑰鹹憲(遞築衊範艱膚選衊獵鑰) = 鏇遞鏇遞艱膚遞淵簾顧鏇鑰壓蓋夢簾築繭鬱製 (夢簾憲醖襯鹽鹹製鹽壓 ) 更多	积极	2019-10-01