更新于：2024-11-01

EGFR positive non-small cell lung cancer

EGFR阳性非小细胞肺癌

更新于：2024-11-01

基本信息

别名

EGF-R positive non-small cell lung cancer、EGFR positive non-small cell lung cancer、Epidermal growth factor receptor positive non-small cell lung cancer

+ [3]

简介-

关联

项与 EGFR阳性非小细胞肺癌相关的药物

Oritinib Mesylate

甲磺酸奥瑞替尼

靶点

EGFR L858R x EGFR T790M x EGFR-Ex19del

作用机制

EGFR T790M抑制剂 [+2]

在研机构

南京圣和药业股份有限公司

原研机构

南京圣和药业股份有限公司

在研适应症

EGFR-T790M 突变非小细胞肺癌 [+2]

非在研适应症

晚期非小细胞肺癌 [+1]

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2024-06-11

Befotertinib Mesylate

甲磺酸贝福替尼

靶点

EGFR T790M

作用机制

EGFR T790M抑制剂

在研机构

贝达药业股份有限公司 [+1]

原研机构

益方生物科技（上海）股份有限公司

在研适应症

EGFR 外显子 19 缺失突变型非小细胞肺癌 [+8]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2023-05-29

Tremelimumab

曲美木单抗

靶点

CTLA4

作用机制

CTLA4抑制剂

在研机构

AstraZeneca PLC [+12]

原研机构

AstraZeneca AB [+1]

在研适应症

肝细胞癌 [+59]

非在研适应症

晚期癌症 [+50]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2022-10-21

198

项与 EGFR阳性非小细胞肺癌相关的临床试验

NCT06014827 / Recruiting临床2期IIT

Phase II Trial of the Addition of Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to First Line Osimertinib in Oligoprogressive EGFR Positive Non-Small Cell Lung Carcinoma

This phase II trial tests how well biologically guided radiation therapy (BgRT) and stereotactic body radiation therapy (SBRT) with osimertinib works for the treatment of EGFR positive non-small cell lung carcinoma that has spread from where it first started (primary site) to a limited number of anatomic sites (oligoprogressive). BgRT is radiation that uses specialized imaging to during treatment to target the active tumor and direct radiation to tumors in order to kill and shrink tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving BgRT with SBRT and osimertinib may kill more tumor cells in patients with oligoprogressive EGFR positive non-small cell lung carcinoma.

开始日期2024-09-25

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06075615 / Not yet recruitingN/A

A Multicenter, Observational Study to Describe the Effectiveness and Treatment Patterns of Dacomitinib Among Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer Patients With Brain Metastasis

The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer which has spread to other parts of the body.
This study is seeking participants who:
have lung cancer that has reached at least the brain.
have a type of gene called epidermoid growth factor receptor. A gene is a part of your DNA that has instructions for making things your body needs to work.
have not received any treatment before.
All participants in this study will receive dacomitnib 1 time a day. Dacomitinib is a tablet that is taken by mouth at home. They can continue to take dacomitnib until their cancer is no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.

开始日期2024-09-01

申办/合作机构

Pfizer Inc.

NCT06631989 / Recruiting临床1/2期

A Phase I/II Multicenter, Open Label, Single-arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of WSD0922-FU in the Treatment of Advanced Non-small Cell Lung Cancer

This study is a multicenter, open label, single-arm phase I/II clinical study of WSD0922-FU conducted in China, including Part A (dose escalation and expansion study) and Part B (dose extension). To explore the safety, tolerability, pharmacokinetic characteristics and efficacy of WSD0922-FU in patients with non-small cell lung cancer (NSCLC) with C797S mutation after first-line third-generation EGFR-TKI resistance (Osimertinib, Almonertinib, Furmonertinib, Befotertinib).

开始日期2024-08-21

申办/合作机构

Wayshine Biopharm

100 项与 EGFR阳性非小细胞肺癌相关的临床结果

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100 项与 EGFR阳性非小细胞肺癌相关的转化医学

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0 项与 EGFR阳性非小细胞肺癌相关的专利（医药）

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535

项与 EGFR阳性非小细胞肺癌相关的文献（医药）

2024-11-01·Respiratory Investigation

Negative-predictive value of SUVmax for Ascertaining the efficacy of osimertinib in EGFR mutation-positive non-small cell lung cancer

Article

作者: Sakata, Shinya ; Tomita, Yusuke ; Inoue, Hiroki ; Saruwatari, Koichi ; Imamura, Kosuke ; Oda, Seitaro ; Sakagami, Takuro ; Anai, Moriyasu ; Ichiyasu, Hidenori ; Akaike, Kimitaka ; Shiraishi, Shinya ; Iyama, Shinji ; Jodai, Takayuki

BACKGROUNDFluorine-¹⁸ 2-fluoro-2-deoxy-d-glucose positron emission tomography/computed tomography (¹⁸F-FDG PET/CT) is routinely used to stage non-small cell lung cancer (NSCLC). However, whether ¹⁸F-FDG accumulation in primary tumors affects the efficacy of osimertinib in patients with epidermal growth factor receptor (EGFR) mutation-positive NSCLC remains unclear.METHODSWe retrospectively investigated 74 patients with advanced or postoperative recurrent EGFR mutation-positive NSCLC who underwent ¹⁸F-FDG PET/CT and were treated with osimertinib as first-line therapy between September 2018 and March 2023 at Kumamoto University Hospital. The maximum standardized uptake value (SUVmax) of each primary tumor was measured, and the patients were divided into two groups according to the median SUVmax. The effects of SUVmax on progression-free survival (PFS) and overall survival (OS) were assessed using a multivariate Cox proportional hazards model.RESULTSThe median SUVmax was 8.2 (interquartile range: 5.5-11.4). The median PFS in the high SUVmax group (≥8.2) was significantly shorter than that in the low SUVmax group (<8.2). The respective median PFSs were 11.2 months (95% confidence interval [CI]: 3.1-19.3 months) vs. 22.9 months (95% CI: 12.4-33.4 months) (P = 0.015), although the OS values did not differ significantly. Multivariate analysis showed that a high SUVmax was an independent negative predictive factor for PFS in patients treated with osimertinib (hazard ratio, 2.25; 95% CI: 1.15-4.39, P = 0.017).CONCLUSIONSHigh primary-lesion SUVmax in patients with EGFR mutation-positive NSCLC correlated with shorter PFS with first-line osimertinib therapy, suggesting that SUVmax is a useful predictive marker for the antitumor efficacy of osimertinib.

2024-11-01·Respiratory Investigation

Comparison of efficacy of gefitinib and osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer in patients with poor performance status

Article

作者: Ishikawa, Nobuhisa ; Tanimoto, Takuya ; Yanagawa, Takashi ; Hottta, Takamasa ; Hamai, Kosuke ; Takahashi, Toshiaki ; Kodama, Hiroaki ; Kitani, Kashu ; Murakami, Haruyasu ; Kawakado, Keita ; Kuyama, Shoichi ; Abe, Masaaki ; Isobe, Takeshi ; Tamura, Tomoki ; Nakashima, Kazuhisa ; Tsubata, Yukari

BACKGROUNDThere is a dearth of studies on the efficacy and safety of the tyrosine kinase inhibitors osimertinib (OSI) and gefitinib (GEF) in treating epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), even in patients with poor performance status (PS).METHODSWe retrospectively reviewed and compared data of 113 patients with EGFR mutation-positive NSCLC with Eastern Cooperative Oncology Group PS 2-4 who were administered OSI 80 mg/day or GEF 250 mg/day from May 2016 to March 2022.RESULTSThe GEF group (39 patients; median age: 74 years) included 20 patients with a PS of 2, 17 with a PS of 3, and 2 with a PS of 4. The OSI group (74 patients; median age: 76 years) included 48 patients with a PS of 2, 24 with a PS of 3, and 2 with a PS of 4. The overall response rates were 69% and 66% in the GEF and OSI groups, respectively. The disease control and PS improvement rates were 89% and 51% in both groups, respectively. The median progression-free survival in the GEF and OSI groups was 6.9 and 9.2 months, respectively (p = 0.15). The OSI group experienced better overall survival than the GEF group (median: 20.9 vs. 13.0 months, p = 0.0031). The incidence of pneumonitis was 10% and 11% in the GEF and OSI groups, respectively. One treatment-related death owing to pneumonitis occurred in the GEF group.CONCLUSIONSOSI may be a useful treatment for untreated EGFR mutation-positive NSCLC with poor PS.

2024-10-01·Respirology Case Reports

Ramucirumab‐induced ascites with endothelial growth factor receptor mutation‐positive non‐small cell lung cancer: Two case reports

Article

作者: Kuyama, Shoichi ; Tamura, Tomoki ; Shiraha, Keisuke ; Koyanagi, Taisaku ; Nishii, Kazuya ; Umeno, Takahiro

AbstractRamucirumab (RAM) has been approved for the treatment of non‐small cell lung cancer (NSCLC). Here, we report two cases of RAM‐induced ascites with epidermal growth factor receptor‐mutant NSCLC. Patient 1, a 72‐year‐old man, developed ascites 20 months after erlotinib (ERL) and RAM administration, which resolved after their discontinuation and performing paracentesis. Patient 2, an 83‐year‐old woman, developed ascites 9 months after ERL and RAM administration, which resolved after RAM discontinuation and furosemide administration. Ramucirumab administration can cause ascites due to increased hepatic sinusoidal pressure. Clinicians should be aware of RAM‐induced ascites in patients with NSCLC and should appropriately manage it.

项与 EGFR阳性非小细胞肺癌相关的新闻（医药）

2024-10-31

·药研网

科伦博泰 TROP2 ADC 新药第3项适应症申报上市

10月31日，CDE官网最新公示，科伦博泰申报的注射用芦康沙妥珠单抗新适应症上市申请获得受理。根据科伦博泰公告介绍，本次申报上市的适应症为：用于经表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗后进展的EGFR突变局部晚期或转移性非小细胞肺癌成人患者。这是芦康沙妥珠单抗(sac-TMT)获NMPA受理的第三个NDA。该申请已于日前被CDE拟纳入优先审评。 OptiTROP-Lung04是一项多中心、随机、注册III期临床研究，评估芦康沙妥珠单抗(sac-TMT)单药对比培美曲塞联合铂类治疗经EGFR-TKI治疗后进展的EGFR突变局部晚期或转移性NSCLC患者中的疗效和安全性。在预设的期中分析中，与培美曲塞联合铂类相比，芦康沙妥珠单抗(sac-TMT)单药在主要研究终点盲态独立评审委员会（BICR）评估的无进展生存期(PFS)具有显著统计学意义和临床意义的改善。 2024年美国癌症研究协会（AACR）年会上，研究人员公布了芦康沙妥珠单抗用于既往接受过治疗的晚期非小细胞肺癌（NSCLC）患者的2期研究的最新疗效和安全性结果。结果显示，在EGFR突变型NSCLC患者亚组（既往接受EGFR-TKI治疗期间或之后病情有所进展且其中50%的患者至少经历过1L化疗失败）中，芦康沙妥珠单抗的客观缓解率（ORR）为60%，中位无进展生存期（PFS）为11.5个月，中位总生存期（OS）为22.7个月。芦康沙妥珠单抗(sac-TMT)的安全性良好，未发现新的安全性信号。此前，芦康沙妥珠单抗(sac-TMT)两项NDA已获NMPA受理。分别用于既往至少接受过2种系统治疗（其中至少1种治疗针对晚期或转移性阶段）的局部晚期或转移性三阴性乳腺癌(TNBC)患者单药治疗接受EGFR-TKI和含铂化疗治疗失败的局部晚期或转移性EGFR突变NSCLC成人患者芦康沙妥珠单抗 (sac-TMT)是科伦博泰与默沙东（MSD）联合开发的一款靶向TROP-2的抗体偶联药物（ADC），靶向NSCLC、乳腺癌(BC)、胃癌(GC)、妇科肿瘤等晚期实体瘤。科伦博泰首席执行官葛均友博士表示“非常高兴芦康沙妥珠单抗（sac-TMT）再获第三项NDA。相信芦康沙妥珠单抗将在肿瘤领域大放异彩，为全球健康事业贡献中国力量”。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾 1 8月 | 高达22家药企裁员 2 国产首款四价HPV疫苗拟纳入优先审评 3 3. 7亿美元!今年规模最大的生物医药融资诞生

优先审批AACR会议临床3期申请上市抗体药物偶联物

2024-10-31

·医药观澜

科伦博泰ADC新药第三项适应症申报上市，治疗肺癌

▎药明康德内容团队报道今日（10月31日），中国国家药监局药品审评中心（CDE）官网最新公示，科伦博泰申报的注射用芦康沙妥珠单抗新适应症上市申请获得受理。根据科伦博泰公告介绍，本次申报上市的适应症为：用于经表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗后进展的EGFR突变局部晚期或转移性非小细胞肺癌成人患者。该项申请几日前刚刚被CDE拟纳入优先审评。截图来源：CDE官网芦康沙妥珠单抗（sac-TMT，前称SKB264/MK-2870）是科伦博泰与默沙东（MSD）联合开发的一款靶向TROP-2的抗体偶联药物（ADC）。TROP-2抗癌药物开发的潜力靶点之一。它的过表达在肿瘤生长过程中起着关键作用，与更具侵袭性的疾病和预后不良相关。目前，芦康沙妥珠单抗已有两项适应症上市申请获得CDE受理，并被纳入优先审评，分别为：用于既往至少接受过2种系统治疗的不可切除的局部晚期或转移性三阴性乳腺癌成人患者；治疗接受EGFR-TKI疗法和含铂化疗治疗失败的局部晚期或转移性EGFR突变非小细胞肺癌患者。本次是芦康沙妥珠单抗第三次申报上市且被拟纳入优先审评，针对适应症为：经EGFR-TKI治疗失败的局部晚期或转移性EGFR突变非小细胞肺癌成人患者。根据科伦博泰公告介绍，本次芦康沙妥珠单抗申报上市是基于OptiTROP-Lung04关键3期研究的积极结果。OptiTROP-Lung04是一项多中心、随机、注册3期临床研究，评估芦康沙妥珠单抗单药对比培美曲塞联合铂类治疗经EGFR-TKI治疗后进展的EGFR突变局部晚期或转移性NSCLC患者中的疗效和安全性。在预设的期中分析中，与培美曲塞联合铂类相比，芦康沙妥珠单抗单药在主要研究终点盲态独立评审委员会(BICR)评估的无进展生存期(PFS)具有显著统计学意义和临床意义的改善。。 2024年美国癌症研究协会（AACR）年会上，研究人员公布了芦康沙妥珠单抗用于既往接受过治疗的晚期非小细胞肺癌（NSCLC）患者的2期研究的最新疗效和安全性结果。结果显示，在EGFR突变型NSCLC患者亚组（既往接受EGFR-TKI治疗期间或之后病情有所进展且其中50%的患者至少经历过1L化疗失败）中，芦康沙妥珠单抗的客观缓解率（ORR）为60%，中位无进展生存期（PFS）为11.5个月，中位总生存期（OS）为22.7个月。参考资料： [1] 中国国家药监局药品审评中心官网. Retrieved Oct 31, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c [2]自愿公告核心产品芦康沙妥珠单抗(SAC-TMT)的新药申请获国家药品监督管理局受理. Retrieved Oct 31, 2024, from http://www.cninfo.com.cn/new/disclosure/detail?plate=hke&orgId=9900059184&stockCode=06990&announcementId=1221579651&announcementTime=2024-10-31%2007:30 [3]AACR2024 | 科伦博泰在AACR大会公布TROP2 ADC芦康沙妥珠单抗SKB264/sac-TMT两项研究结果. Retrieved Apr 8, 2024, from https://mp.weixin.qq.com/s/eEcbhI73leY-CIpDDNu4MA 本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

AACR会议优先审批抗体药物偶联物临床3期申请上市

2024-10-25

·ioncology

ESMO ASIA 2024丨一文了解胸部肿瘤口头报告

点击蓝字关注我们 2024年欧洲肿瘤内科学会亚洲年会（ESMO Asia Congress 2024）将于当地时间12月6日~8日在新加坡召开。ESMO ASIA是亚太地区讨论肿瘤学领域重磅突破的领先平台，近日在官方网站正式公布本次大会的摘要题目及作者信息。肿瘤瞭望小编带您先睹为快，一览胸部肿瘤领域入选优选口头报告（Proffered Paper）和微型口头报告（Mini Oral）的临床研究。 1 优选口头报告（Proffered Paper）摘要号：LBA8 英文标题：Phase II trial of atezolizumab plus carboplatin and paclitaxel in patients with metastatic or recurrent thymic carcinoma: Marble study 中文标题：阿替利珠单抗+卡铂/紫杉醇治疗转移性或复发性胸腺癌的II期临床试验：Marble研究讲者：Tomoyasu Mimori (日本) 摘要号：625O 英文标题：Efficacy and safety of Lucitanib (AL3810) in second or subsequent-line treatment of advanced recurrent or metastatic thymic carcinoma: a randomized, double-blind, placebo-controlled multicenter phase II trial 中文标题：Lucitanib在晚期复发或转移性胸腺癌二线或后续治疗中的疗效和安全性：一项随机、双盲、安慰剂对照的多中心II期试验讲者：方文涛（上海交通大学医学院附属胸科医院）摘要号：LBA5 英文标题：Zongertinib in patients with HER2-mutant NSCLC: Updated analysis of Beamion LUNG-1 中文标题：Zongertinib治疗HER2突变型NSCLC患者：Beamion LUNG-1的最新分析讲者：Noboru Yamamoto (日本) 摘要号：LBA6 英文标题：PACIFIC-5: A phase 3 study of consolidation durvalumab (D) in patients (pts) with unresectable stage III NSCLC and no progression after concurrent or sequential chemoradiotherapy (cCRT or sCRT) 中文标题：PACIFIC-5：针对同步或序贯放化疗（cCRT或sCRT）后未出现进展不可切除III期NSCLC患者进行巩固性度伐利尤单抗治疗的III期研究讲者：吴一龙（广东省人民医院）摘要号：LBA7 英文标题：Efficacy and safety of datopotamab deruxtecan (Dato-DXd) in patients (pts) with previously-treated EGFR-mutated advanced non-small cell lung cancer (NSCLC): a pooled analysis of TROPION-Lung01 and TROPION-Lung05 中文标题：Dato-DXd对既往接受过治疗的EGFR突变晚期非小细胞肺癌患者的疗效和安全性：TROPION-Lung01和TROPION-Lung05的汇总分析讲者：Myung-Ju Ahn (韩国) 2 微型口头报告（Mini Oral）摘要号：626MO 英文标题：Tarlatamab in previously treated small cell lung cancer (SCLC): Subgroup analysis of patients from the Asia region in the phase 2 DeLLphi-301 study 中文标题：Tarlatamab治疗既往接受过治疗的小细胞肺癌：II期DeLLphi-301研究中亚洲地区患者的亚组分析讲者：Hiroaki Akamatsu (日本) 摘要号：627MO 英文标题：POD1UM-304: Phase 3 Study of Retifanlimab Plus Platinum-Based Chemotherapy (Chemo) as First-Line (1L) Therapy For Nonsquamous or Squamous Metastatic Non–Small Cell Lung Cancer (mNSCLC) 中文标题：POD1UM-304：Retifanlimab+铂类化疗作为非鳞或鳞状转移性非小细胞肺癌一线疗法的III期研究讲者：陆舜(上海交通大学医学院附属胸科医院) 摘要号：614MO 英文标题：A Phase Ⅱ Study of Becotatug (JMT101) in Combination with Osimertinib (Osi) in Patients (pts) with classical EGFR-mutated Non-small Cell Lung Cancer (NSCLC) (BOOSTER Study) 中文标题：Becotatug联合奥希替尼治疗经典型EGFR突变非小细胞肺癌患者的Ⅱ期BOOSTER临床研究讲者：张力(中山大学肿瘤防治中心) 摘要号：630MO 英文标题：First-line (1L) osimertinib (osi) ± platinum-pemetrexed chemotherapy (CTx) for EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC): FLAURA2 Asian cohort 中文标题：一线奥希替尼±铂类-培美曲塞化疗治疗EGFR突变晚期非小细胞肺癌：FLAURA2亚洲队列讲者：James Chih-Hsin Yang (中国台湾) 摘要号：628MO 英文标题：Comparing Subcutaneous vs Intravenous Amivantamab with Lazertinib in EGFR-Mutated Advanced NSCLC: Analysis of Asian Patients From PALOMA-3 中文标题：比较皮下注射vs静脉注射Amivantamab联合Lazertinib治疗EGFR突变晚期NSCLC：对PALOMA-3亚洲患者的分析讲者：Se-Hoon Lee (韩国) 摘要号：629MO 英文标题：ALESIA 7-year update: alectinib vs crizotinib in Asian patients (pts) with treatment-naïve advanced ALK+ non-small cell lung cancer (NSCLC) 中文标题：ALESIA研究7年随访更新：阿来替尼vs克唑替尼在未经治疗的晚期ALK+非小细胞肺癌亚洲患者中的疗效对比讲者：周彩存(上海市东方医院) （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

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