预约演示
更新于：2026-08-28
Amivantamab-VMJM
埃万妥单抗
更新于：2026-08-28
概要
基本信息
药物类型 双特异性抗体 |
别名 Amivantamab、amivantamab-vmjw、Amivantamab（Genetical Recombination） + [15] |
作用方式 拮抗剂、抑制剂 |
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) |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2021-05-21), |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国)、孤儿药 (韩国)、突破性疗法 (中国)、优先审评 (美国)、突破性疗法 (美国) |
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结构/序列
Sequence Code 143885L
来源: *****
Sequence Code 13387733H
来源: *****
Sequence Code 13387743H
来源: *****
Sequence Code 13387747L
来源: *****
关联
53
项与 埃万妥单抗 相关的临床试验JPRN-jRCT1031260351
JCOG2507: A Phase III Randomized Controlled Trial Comparing Osimertinib plus Carboplatin plus Pemetrexed with Amivantamab plus Lazertinib for EGFR-Mutant Advanced Non-Squamous Non-Small Cell Lung Cancer (APEX)
开始日期2026-07-30 |
申办/合作机构- |
NCT07586202
A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer
The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes, including EGFR.
开始日期2026-07-28 |
NCT07744529
A Single-Arm Phase II Exploratory Clinical Study of Amivantamab Combined With Intrathecal Pemetrexed for Leptomeningeal Metastasis From EGFR-Mutated Lung Adenocarcinoma
The goal of this clinical trial is to learn whether amivantamab combined with intrathecal pemetrexed is safe and may help treat leptomeningeal metastasis in adults with EGFR-mutant lung adenocarcinoma. Leptomeningeal metastasis occurs when cancer cells spread to the membranes surrounding the brain and spinal cord or to the cerebrospinal fluid. It is a serious complication of advanced lung cancer and is difficult to treat because many systemic drugs do not reach high enough levels in the cerebrospinal fluid.
The main questions this study aims to answer are:
What medical problems do participants have when receiving amivantamab combined with intrathecal pemetrexed? How long do participants live without their disease getting worse after receiving this treatment? How long do participants survive after starting this treatment?
Participants will:
Receive amivantamab by intravenous infusion according to the study schedule. Receive intrathecal pemetrexed, together with dexamethasone and normal saline, once every week.
Continue their original EGFR tyrosine kinase inhibitor treatment as determined by the study doctor.
Have cerebrospinal fluid pressure measured and cerebrospinal fluid samples collected before each intrathecal treatment.
Have tests of cerebrospinal fluid, including routine tests, biochemical tests, tumor markers, albumin, IgG, and cytology.
Have imaging tests, including enhanced MRI, about every 3 months to check the disease.
Be followed by clinic visits and/or telephone calls to collect information about survival, disease status, side effects, and any later cancer treatments.
The main questions this study aims to answer are:
What medical problems do participants have when receiving amivantamab combined with intrathecal pemetrexed? How long do participants live without their disease getting worse after receiving this treatment? How long do participants survive after starting this treatment?
Participants will:
Receive amivantamab by intravenous infusion according to the study schedule. Receive intrathecal pemetrexed, together with dexamethasone and normal saline, once every week.
Continue their original EGFR tyrosine kinase inhibitor treatment as determined by the study doctor.
Have cerebrospinal fluid pressure measured and cerebrospinal fluid samples collected before each intrathecal treatment.
Have tests of cerebrospinal fluid, including routine tests, biochemical tests, tumor markers, albumin, IgG, and cytology.
Have imaging tests, including enhanced MRI, about every 3 months to check the disease.
Be followed by clinic visits and/or telephone calls to collect information about survival, disease status, side effects, and any later cancer treatments.
开始日期2026-05-28 |
申办/合作机构- |
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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311
项与 埃万妥单抗 相关的文献（医药）2026-12-31·JOURNAL OF MEDICAL ECONOMICS
Cost comparison of osimertinib plus platinum-pemetrexed versus amivantamab plus lazertinib for the first-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer
Article
作者: Hearmon, Natalie ; Upton, Elysia ; Procter, Emily ; Nieva, Jorge J. ; Rattigan-Brown, Yanique ; Freeman, Harry ; Lopes, Gilberto de Lima ; Karia, Pritesh
OBJECTIVES:
Novel first-line (1L) combination regimens offer improved efficacy for patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) versus the standard of care, but their costs have not been comprehensively evaluated. Total and differential costs of 1L osimertinib plus platinum-pemetrexed, intravenous (IV) amivantamab plus lazertinib, and subcutaneous (SC) amivantamab plus lazertinib were estimated from a United States (US) payer perspective.
METHODS:
A cost of care model was developed to assess treatment acquisition, administration, disease management, and adverse event (AE) management costs for osimertinib plus platinum-pemetrexed versus IV and SC amivantamab plus lazertinib for patients with EGFRm NSCLC. A one-year time horizon was chosen to allow for direct treatment comparison; a one-year treatment duration was assumed for treat-to-progression regimen components.
RESULTS:
The total first-year cost per-patient for osimertinib plus platinum-pemetrexed (all-payer perspective: $172,600; private perspective: $253,529; Medicare perspective: $84,926) was over twofold lower than for IV amivantamab plus lazertinib (all-payer perspective: $418,176; private perspective: $618,240; Medicare perspective: $201,441) and for SC amivantamab plus lazertinib (all-payer perspective: $419,718; private perspective: $621,166; Medicare perspective: $201,482). This translated to per-patient cost savings of $245,577; $364,711; and $116,514 for osimertinib plus platinum-pemetrexed versus IV amivantamab plus lazertinib and $247,118; $367,637; and $116,555 versus SC amivantamab plus lazertinib for the all-payer, private, and Medicare perspectives, respectively.
LIMITATIONS:
Limited data availability necessitated cost conversions across payer perspectives and assumptions for select inputs, including specific concomitant medication durations. Additionally, as any payer-negotiated discounts for treatment are confidential, model treatment acquisition costs reflected list prices. These data limitations contributed to uncertainty surrounding model inputs.
CONCLUSIONS:
From a US payer perspective, osimertinib plus platinum-pemetrexed was associated with substantially lower overall costs compared with IV and SC amivantamab plus lazertinib for the 1L treatment of patients with EGFRm locally advanced or metastatic NSCLC.
2026-09-01·ORAL ONCOLOGY
Intravenous amivantamab after cetuximab failure in recurrent or metastatic head and neck squamous cell carcinoma: a single-centre retrospective real-world cohort study
Article
作者: Lin, Fengjuan ; Xue, Liqiong ; Guo, Ye ; Tang, Wenbo ; Zhou, Jiuli ; Zhao, Wei
BACKGROUND:
Patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who exhaust platinum, immune checkpoint inhibitors (ICIs), and cetuximab lack standard options. The OrigAMI-4 trial showed subcutaneous amivantamab activity in anti-EGFR-naïve patients; real-world intravenous (IV) amivantamab data after cetuximab failure are absent.
METHODS:
We retrospectively analysed consecutive R/M HNSCC patients treated with IV amivantamab monotherapy (November 2024-July 2025) after progression on standard therapies. Response was assessed per RECIST 1.1; toxicity per CTCAE v5.0.
RESULTS:
Twenty patients were included (median age 54 years; 70.0% male; median four prior systemic lines). All received prior platinum and ICIs; 18 (90.0%) progressed on cetuximab. At a median follow-up of 6.8 months, confirmed ORR was 30.0% (6/20; 95% CI 11.9-54.3) ; DCR at first reassessment (6 weeks) was 80.0% (16/20; 95% CI 56.3-94.3) and confirmed DCR at 12 weeks was 45.0% (9/20; 95% CI 23.1-68.5). Median PFS was 3.0 months (95% CI 2.3 to not reached) and median OS 9.7 months (95% CI 6.8 to not reached). The most frequent treatment-related adverse events were hypoalbuminaemia (90.0%), rash (70.0%), and infusion-related reactions (45.0%; all grade 1-2); two patients had grade 3 events, none discontinued treatment.
CONCLUSION:
In this small retrospective cohort, IV amivantamab showed antitumour activity in heavily pretreated, cetuximab-exposed R/M HNSCC, with a 30% confirmed ORR, 45% confirmed 12-week DCR, 9.7-month median OS, and no treatment discontinuations for toxicity. These data suggest that dual EGFR-MET targeting may retain clinical utility after anti-EGFR failure, and support prospective evaluation with biomarker stratification.
2026-09-01·EUROPEAN JOURNAL OF CANCER
Assessing time to symptomatic progression, a patient-relevant efficacy endpoint, in the MARIPOSA study in non-small cell lung cancer
Article
作者: Ord, Priya ; Ennis, Mariah ; Lu, Shun ; Felip, Enriqueta ; Gadgeel, Shirish M ; Nguyen, Danny ; Bauml, Joshua M ; Frosien, Markus ; Montes, Lizbett Vanessa García ; Akamatsu, Hiroaki ; Lin, Chien-Chung ; Forster, Martin D ; Lee, Se-Hoon ; Charoentum, Chaiyut ; Schuette, Wolfgang ; Kerßenboom, Ronja ; Cho, Byoung Chul ; Meißner, Janka ; Kowalyszyn, Ruben ; Urban, Damien ; Misch, Daniel ; Arslan, Cagatay ; Fennema, Elizabeth ; Cruz-Correa, Marcia ; Aguilar, Andres ; Daksh, Mahesh ; Girard, Nicolas ; Sethi, Seema ; Owen, Scott ; Cruz, Felipe Melo ; Sermon, Jan
INTRODUCTION:
In the phase 3 randomized MARIPOSA study, amivantamab and lazertinib combination therapy demonstrated improved progression-free survival (PFS) and overall survival (OS) versus osimertinib in participants with previously untreated, epidermal growth factor receptor-mutated advanced non-small cell lung cancer. Time to symptomatic progression (TTSP) was introduced to assess clinical worsening and complement endpoints that investigate radiographic disease progression and patient-reported outcomes. TTSP provides an easily interpretable measure of disease-specific symptom worsening to further support patient experience.
METHODS:
In MARIPOSA, TTSP was quantitatively assessed as a secondary efficacy endpoint and defined as the time from randomization until participants experience disease-specific symptom worsening requiring a clinical intervention or treatment change, or death. To evaluate the impact of amivantamab and lazertinib on TTSP considering its established OS benefit against osimertinib, an exploratory analysis censoring death events was performed.
RESULTS:
At the final protocol-specified OS analysis (median follow up: 37.8 months), median TTSP was 43.6 months with amivantamab and lazertinib versus 29.3 months with osimertinib (hazard ratio [HR]: 0.69; 95% confidence interval [CI]: 0.57-0.83; p < 0.0001). Amivantamab and lazertinib reduced deaths following a TTSP event compared to osimertinib. A strong correlation between TTSP and PFS or OS was observed.
CONCLUSIONS:
Amivantamab and lazertinib significantly delayed TTSP versus osimertinib. TTSP offers a clinician-validated measurement of disease-specific symptom worsening, capturing symptoms perceived by patients that prompt clinical action. TTSP is highly correlated with PFS and OS, providing complementary insights alongside traditional endpoints. TTSP enhances understanding of treatment benefit and supports informed clinical decision-making by integrating patient experience.
1,698
项与 埃万妥单抗 相关的新闻（医药）2026-08-27
前言
News Today
皮下给药正成为全球生物制药领域最具变革性的方向之一，相比静脉输注，皮下制剂可将数小时的输液时间缩短至几分钟。重组人透明质酸酶（rHuPH20）作为这一领域的核心技术，通过特异性降解皮下组织中的透明质酸，实现快速、大剂量、高体积的皮下药物递送。
从肿瘤到自身免疫疾病，从单抗到双抗乃至ADC，越来越多的重磅药物正借助这一“皮下渗透增强剂”实现从静脉输注（IV）到皮下注射（SC）的华丽转身。本文将系统盘点全球已上市及临床在研的含rHuPH20皮下药物，梳理其背后的技术平台与市场情况。
一、rHuPH20：打开皮下给药大门的“钥匙”
rHuPH20是一种采用中国仓鼠卵巢（CHO）细胞表达的重组人透明质酸酶，它在皮下细胞外基质中局部、短暂地降解透明质酸，降低组织黏度，促进联合用药的快速分散和吸收，单次注射体积可从传统≤2mL扩展至数mL乃至更大。
与早期动物来源的透明质酸酶相比，rHuPH20纯度更高，批次间差异小，免疫原性和病原体风险大幅降低。
目前全球已上市的含rHuPH20皮下制剂，绝大多数依托Halozyme公司的ENHANZE®平台，该技术于2005年获得FDA批准，最初作为辅助渗透剂，后演变为大分子皮下制剂的核心赋能工具。
截至目前，全球已有十余款含rHuPH20的皮下制剂获批，覆盖肿瘤、自身免疫疾病、神经系统疾病及免疫球蛋白替代治疗等领域，另有多个单抗/双抗及ADC候选药物处于临床阶段。
二、已上市含rHuPH20皮下药物
1. 肿瘤领域：
帕妥珠曲妥珠单抗皮下注射液（Phesgo）、阿替利珠单抗皮下注射液（Tecentriq Hybreza）、达雷妥尤单抗皮下注射液（Darzalex Faspro）、利妥昔单抗皮下注射液（Rituxan Hycela）、曲妥珠单抗皮下注射液（Herceptin Hylecta）、纳武利尤单抗皮下注射液（Opdivo Qvantig）及埃万妥单抗皮下注射液（Rybrevant Faspro）均借助rHuPH20实现快速皮下给药且已获批。
2. 自身免疫与神经系统疾病：
艾加莫德皮下注射液（Vyvgart Hytrulo）用于全身型重症肌无力等，奥瑞珠单抗皮下注射液（Ocrevus Zunovo）用于多发性硬化，均采用rHuPH20共配方技术。
3. 免疫球蛋白领域：
武田的免疫球蛋白皮下输注制剂HYQVIA同样借助rHuPH20实现大剂量免疫球蛋白的皮下递送，与共配方皮下注射不同，HYQVIA采用分体双瓶设计，rHuPH20与免疫球蛋白分瓶包装，通过序贯输注方式先后给药。
全球已上市含rHuPH20皮下药物清单及关键信息如下表 [1-2]：
截至2026年8月，产品审批状态以各监管机构最新公告为准
三、临床在研含rHuPH20皮下药物
rHuPH20平台的合作网络仍在扩张，Halozyme近年先后与武田（维得利珠单抗皮下制剂）、GSK（多肿瘤靶点及ADC）、Incyte（First-in-class抗癌药物INCA033989）、Skye Bioscience（肥胖治疗药物Nimacimab）及Merus等达成授权合作。
此外，罗氏继续推进Ocrevus皮下制剂等多款产品全球布局，Alexion也在评估Ravulizumab与rHuPH20联用的皮下给药方案。
含rHuPH20皮下制剂在研候选药物及临床进展如下表 [3]：
截至2026年8月，产品审批状态以各监管机构最新公告为准
结语
从皮下辅助用酶到核心驱动技术，rHuPH20用二十年完成的不只是技术迭代，更推动了一场关于给药方式的观念转变。随着技术平台持续迭代、适应症版图不断扩展，皮下给药正从少数重磅药物的“升级选项”变为大分子药物递送的“新常态”，这一趋势已成为行业演进的重要方向。
[ END ] .
REF:
[1] Lu RM, Chen YC, Yang CY. Structure and function of therapeutic antibodies approved by the US FDA in 2024. Antibody Therapeutics. 2025. doi:10.1093/abt/tbaf014
[2] U.S. Food and Drug Administration. FDA approves amivantamab and hyaluronidase‑lpuj subcutaneous injection. 2025.
[3] Zhang L, Li Y, Wang H, et al. From permeation enhancer to therapeutic enabler: Advances, applications, and translational perspectives in hyaluronidase-based drug delivery. Materials Today Bio. 2026. doi:10.1016/j.mtbio.2026.100872
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本文内容系基于公开资料与学术文献的整理汇总，作者仅为信息传播之目的进行客观陈述，不保证所涉信息（包括但不限于数据、结论、预测）的绝对准确、完整或最新，亦不对因依赖本文信息而引发的任何直接或间接损失承担责任。
本文仅供专业人员参考学习，文中提及的技术路线及产品信息仅为学术性介绍，不构成任何商业推荐、用药建议、临床决策依据或投资建议，亦不构成对任何公司证券的购买邀约或邀请。
本文可能包含前瞻性陈述（包括但不限于对业务战略、未来运营、研发进展、临床试验结果、商业化前景及财务表现等方面的描述），此类陈述系作者基于当前预期、假设与预测作出，涉及已知及未知的风险及不确定性，实际结果可能与前瞻性陈述所明示或暗示的结果存在重大差异。基于上述原因，作者不承担更新或修订任何前瞻性陈述的义务。
文中引用的图表/原文版权归原文献作者所有，如有侵权内容，请联系删除。
抗体药物偶联物申请上市临床结果临床2期
2026-08-27
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作者：Tony
在肺癌的精准治疗领域，EGFR突变是最受关注的治疗靶点之一。从一代到三代EGFR靶向药，无数患者因此获得了长期生存的机会。
但耐药，始终是绕不开的难题。尤其当三代EGFR靶向药奥希替尼也出现耐药后，患者常常面临“无靶向药可用”的困境。
所幸，医学的脚步从未停歇。近两年，一个全新的治疗思路正在打破这一困局——EGFR/MET双特异性抗体。这类药物与传统的小分子靶向药不同，它能同时“锁定”EGFR和MET两个靶点，阻断肿瘤生长的信号通路。以埃万妥单抗（Amivantamab） 为代表的EGFR/MET双抗，已经在EGFR突变晚期非小细胞肺癌的一线治疗、EGFR 20号外显子插入突变以及奥希替尼耐药后治疗等多个场景中取得了突破性进展。
为什么说EGFR/MET双抗正在改写治疗格局？
从数据来看，这种创新药物给出了非常亮眼的成绩：
一线治疗EGFR敏感突变：MARIPOSA研究显示[1]，埃万妥单抗联合兰泽替尼一线治疗EGFR经典突变晚期NSCLC，中位总生存期（OS）超过4年，相比奥希替尼单药延长超1年，死亡风险降低25%。基于这一结果，该方案已于2025年8月获中国NMPA批准。
攻克EGFR 20外显子插入突变：这类突变对传统EGFR靶向药天然耐药，预后一直不理想。而PAPILLON研究证实[2]，埃万妥单抗联合化疗一线治疗EGFR ex20ins突变患者，中位无进展生存期（PFS）达11.4个月，显著优于单纯化疗的6.7个月。该方案已被NCCN指南推荐为一线治疗方案。
应对奥希替尼耐药：对于奥希替尼耐药后出现MET扩增等旁路激活机制的患者，EGFR/MET双抗提供了新的靶向治疗可能。
用药方式也有了革命性的改变。2025年12月，埃万妥单抗皮下注射剂型正式在中国获批上市。皮下注射的平均给药时间不足5分钟，相比传统静脉输注数小时的耗时，提升了患者的用药便利性和治疗体验。2026年1月，NCCN指南已将皮下注射剂型正式纳入推荐。
然而，任何一个新药的问世，都伴随着患者和家属最朴素的追问：
这个药到底怎么用？和奥希替尼有什么区别？
耐药后还能用吗？哪些人最适合？
皮下注射和静脉输注效果一样吗？
副作用大不大？真实世界中有哪些需要警惕的风险？
为解答这些问题，与癌共舞论坛特别邀请到了南京天印山医院李慧教授，于8月28日（星期五）晚19点开展科普直播，并由深受病友们信赖的鹰版担任主持人，围绕“EGFR/MET双特异性抗体在肺癌中的应用”这一主题，帮助大家系统认识这类创新药物的来龙去脉。
直播全程设置专属答疑环节，大家可以带着最关心的问题，在评论区留言，就有机会获得专家针对性答疑。
主讲嘉宾介绍
李慧教授
副主任 主任医师 医学博士
南京天印山医院胸部肿瘤内科
中国药科大学硕士生导师
中国临床肿瘤学会（CSCO）老年肿瘤防治专委会 委员兼秘书
中国临床肿瘤学会（CSCO）抗肿瘤药物安全管理 专家委员会委员
中国医药创新促进会抗肿瘤药物临床研究专业 委员会委员
江苏省免疫学会中医药免疫学专委会委员
江苏省社会办医肿瘤康复专委会委员
江苏省老年学会中西医结合诊疗专委会委员
南京自然医学会中西医整合肿瘤分会委员
《临床肿瘤学杂志》、《International Open Medical Journal》编委
以主要研究者参与国内外新药临床研究80 多项；以第一作者发表核心期刊和SCI 文章十余篇，参编专著 2 项；获院内和CSCO 基金多项；2022 年作为主要完成人之一获江苏省抗癌协会科学技术三等奖
主持人介绍
鹰版 超级版主
与癌共舞论坛
与癌共舞公益论坛（www.yuaigongwu.com）联合创始人
与癌共舞论坛超级版主，病友一般称呼“鹰版”
中国抗癌协会肿瘤防治科普专业委员会委员
《中国肿瘤患者膳食营养建议》编委
《CSCO NSCLC患者指南》编委
在陪伴母亲抗癌的10年时间内，根据自己母亲的实际治疗过程，结合自己的专业知识，撰写了多篇关于肺癌治疗、基因突变检测的科普文章。在与癌共舞论坛上记录母亲抗癌过程的治疗帖阅读量超过841万；自2016年开始在公众号上撰写发表的跨越五年系列文章及科普文章，累计阅读量近百万。
自2017年起，主持肿瘤相关科普直播500+场，为广大肺癌患者树立科学、正确的抗癌理念提供了重要的参考和借鉴，鼓舞了数十万肿瘤患者及家属。
直播时间
2026年8月28日 19:00-20:00
直播主题
EGFR/MET双特异性抗体在肺癌中的应用
直播地址
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参考文献
[1] Cho BC, Lu S, Felip E, et al. Overall Survival with Amivantamab–Lazertinib in EGFR-Mutated Advanced NSCLC. N Engl J Med.
[2]Zhou C, Tang KJ, Cho BC, Liu B, Paz-Ares L, Cheng S, Kitazono S, Thiagarajan M, Goldman JW, Sabari JK, Sanborn RE, Mansfield AS, Hung JY, Boyer M, Popat S, Mourão Dias J, Felip E, Majem M, Gumus M, Kim SW, Ono A, Xie J, Bhattacharya A, Agrawal T, Shreeve SM, Knoblauch RE, Park K, Girard N; PAPILLON Investigators. Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions. N Engl J Med. 2023 Nov 30;389(22):2039-2051. doi: 10.1056/NEJMoa2306441. Epub 2023 Oct 21. PMID: 37870976.
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2026-08-26
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读书笔记丨感恩并传承CTONG-中国肺癌原创临床研究
写意人物丨陆舜教授：从PI的角度看中国创新药的发展
陆舜教授：有的放矢，做肺癌研究领域的“领潮儿”
陆舜教授：沃利替尼有望成为首个代表中国走向全球的肺癌靶向创新药物陆舜：引领中国抗肿瘤药物研发，将肺癌变成慢性病他的愿望：让肺癌变成慢性病——访上海市胸科医院肿瘤科主任陆舜教授医语舜间丨记录陆舜教授肺癌诊疗领域30余年的精彩瞬间上海交通大学附属胸科医院陆舜教授团队肺癌国内外适应症相关研究阶段汇总推动行业前行的力量-十大医学创新专家推动行业前行的力量-十大医学新锐致敬经典，传承未来丨中国胸部肿瘤原创临床研究二十年心路历程（2007-2029）迎难而上丨中国胸部肿瘤临床试验转化研究长三角模式探索长三角肺癌团魂丨中国胸部肿瘤临床试验转化研究长三角模式探索迎难而上的亮剑精神胸部肿瘤 “工业革命” 成果阶段汇总丨中国胸部肿瘤临床试验转化研究长三角模式探索
江浙沪地区历届重要肺癌论坛汇总（长三角地区肺癌论坛系列）
传承与发展丨长三角肺癌代表性著作汇总传承与发展丨长三角肺癌协作组指南/专家共识汇总读书笔记丨长三角肺癌科技成果奖励阶段汇总
直播课丨长三角肺癌协作组-罕见靶点临床试验招募全国巡讲系列汇总
光荣榜丨长三角肺癌协作组陆舜教授团队历届国际会议大会发言汇总
携手共赢丨长三角肺癌与知名药企临床研究合作成果阶段汇总
长三角肺癌协作组青年博士团队组织框架介绍长三角肺癌之光丨星星之火可以燎原-基层肺癌协作组的前世今生共谋江苏省基层医院肺癌未来发展之路
齐聚浙江嘉兴，长三角肺癌再续新篇章——浙江省基层肺癌协作组成立
长三角肺癌之光丨金陵肺癌传承与发展
长三角肺癌之光丨浙江肺癌传承与发展
长三角肺癌之光丨南昌肺癌传承与发展杭州肺癌之光丨嘉兴肺癌（杭州肺癌-嘉兴支）传承与发展杭州肺癌之光丨湖州肺癌（杭州肺癌-湖州支）传承与发展杭州肺癌之光丨台州肺癌（杭州肺癌-台州支）传承与发展光荣榜丨长三角肺癌-国科大支（杭州肺癌）国际会议大会发言汇总历史回顾丨浙江省肿瘤医院胸部肿瘤青年医师精彩亮相2016WCLC
走进中国科学院大学附属肿瘤医院（浙江省肿瘤医院）I期临床试验病房中国科学院大学附属肿瘤医院（浙江省肿瘤医院）I期临床试验病房进修人员招聘公告长三角实体瘤病友交流群系列全面上线
● 中国原创肺癌 ●
●●●Original lung cancer of China●●●
N Engl J Med（3篇），Lancet（3篇），JAMA（1篇），Lancet Oncol（5篇），Lancet Respir Med（7篇），J Clin Oncol（3篇），JAMA Oncol（1篇），Nat Med（1篇），Cancer Cell（2篇），Cancer Discov（1篇），Ann Oncol（2篇），J Thorac Oncol（15篇），Clin Cancer Res（2篇）
中国原创肺癌
时代背景
赶潮儿（1999-2009）
1999年，中国国家食品药品监督管理总局（CFDA）成立，中国自此有了真正药物临床试验质量管理规范GCP指导原则。那时，我国肺癌学者紧跟国外潮流，按国际的临床标准做临床试验。大多临床研究都由国外学者设计方案，当时的中国只能照本宣科。在这10年当中我们和外国人学习临床试验怎么做，临床试验方案是外国学者定的，我们只是执行，只是在贡献患者，没有话语权。
弄潮儿（2009-2019）
2009年，振奋人心的IPASS研究发表，这是中国肺癌学者的姓名首次登上了权威N Engl J Med。届时，我国在自身基础上参与国际大型研究设计。在肺癌领域的临床试验中，中国很多学者开始担任研究的领头人和研究委员会成员，我们参加了方案的讨论，最终的试验方案也根据我们的意见做了一些修订，包括对照组的化疗剂量等方面。虽然我们很少有机会做领头人，但是我们有话语权，可以对试验方案提出我们的意见。
领潮儿（2019- ）
在越来越多的研究中我们开始担任领头人。这有两个原因：一是得益于前20年我们临床医生对临床研究的理解积累、贡献和影响；第二个也是得益于中国创新药企业的发展，中国药厂做的药，临床研究中肯定会有中国人做领头人。
中国胸部肿瘤临床试验转化研究长三角模式探索（2019-2059）四部曲。致敬经典，传承未来丨中国胸部肿瘤原创临床研究二十年心路历程（2007-2029）长三角肺癌团魂丨中国胸部肿瘤临床试验转化研究长三角模式探索迎难而上的亮剑精神
重要历史事件——CTONG成立（2007）成立于赶潮儿阶段末期，发展于弄潮儿阶段并达到高潮。读书笔记丨感恩并传承CTONG-中国肺癌原创临床研究
中国胸部肿瘤协作组（CTONG）启动会：2007年第十届全国肺癌大会
踏歌而行-中国胸部肿瘤研究协作组十年发展历程（2007-2017）发布会：2017年第七届中国肿瘤学临床试验发展论坛
CTONG YOUNG成立：2023年第十三届中国肿瘤学临床试验发展论坛
重要历史事件——ECLUNG成立（2019）成立于领潮儿阶段初期。
长三角肺癌协作组（ECLUNG）启动会：2019年第八届西湖肺癌论坛
迎难而上-长三角肺癌十年发展史（2019-2029）
砥砺前行-长三角肺癌二十年发展史（2019-2039）
踏歌而行-长三角肺癌三十年发展史（2019-2049）
传承发展-长三角肺癌四十年发展史（2019-2059）
ECLUNG YOUNG成立：2021年首届长三角肺癌博士研究论坛
我们的事业：中国胸部肿瘤临床试验转化研究长三角模式探索
中国胸部肿瘤临床试验转化研究长三角模式探索
长三角肺癌临床试验方面有着非常深厚的历史文化底蕴，回顾历史我们发现中国临床肿瘤领域三大前辈（孙燕，廖美琳，管忠震）中，廖美琳教授是唯一一位专注肺癌的资深大咖，1970年在国内成立首个肺癌化疗专业病房，2004年作为主要研究者代表中国大陆肺癌学界参与首项国际多中心临床研究（INTEREST研究），2003年开始举办首届上海国际肺癌论坛，2012年开始举办首届中瑞国际肺癌论坛，并持续至今，影响力深远。陆舜教授在肺癌临床试验方面有着非常丰富的经验，中国首个、世界第二的肺癌第三代EGFR靶向药物阿美替尼获批上市，这是中国自主研发的第三代EGFR靶向药，打破了晚期肺癌治疗耐药后只能依赖一种进口药的困境；中国自主研发的创新1.1类新药赛沃替尼获中国国家药品监督管理局批准上市，可用于治疗MET14号外显子跳跃突变阳性的晚期非小细胞肺癌（NSCLC）患者，作为在全球范围内的首次获批，赛沃替尼不仅填补了中国此类靶向药的空白，还有望成为首个代表中国走向世界的肺癌靶向创新药物；吡咯替尼是首个由中国自主研发的新一代HER2受体抑制剂，在临床研究中疗效远超同类产品。陆舜教授和宋正波教授领衔的吡咯替尼临床研究在国际上首次证实HER2扩增晚期非小细胞肺癌（NSCLC）患者疗效显著，为扩展吡咯替尼在HER2扩增晚期非小细胞肺癌（NSCLC）的适应症做出了历史性贡献，基于以上重大成果陆舜教授荣获2021年第十五届“药明康德生命化学研究奖”。
为了响应“长三角一体化发展规划”，推动肺癌规范化诊治及创新研究，2019年12月底，由上海交通大学附属胸科医院、东部战区总医院、中国科学院大学附属肿瘤医院、浙江大学医学院附属杭州市第一人民医院等40余家来自江、浙、沪、赣、皖地区的医疗机构，共同成立“长三角肺癌协作组”。成立协作组的目的，是通过设计、开展肺癌研究领域的多中心临床试验及转化研究，特殊病例多中心会诊等，为肺癌临床实践提供高级别的循证医学证据，促进长三角地区肺癌的诊疗、转化研究的创新性及前沿性，提高东部地区肺癌的诊治水平和国际影响力。
长三角肺癌青年博士研究团队（长三角肺癌新生代）把中国胸部肿瘤临床试验转化研究长三角模式探索作为奋斗的事业，迎难而上作为中国胸部肿瘤临床试验转化研究长三角模式探索的方向标，长三角肺癌新生代结合时代背景特征在未来四十年时间（2019-2059）选择迎难而上，勇于向各种艰难困苦挑战和亮剑。
“爬雪山”和“过草地”
长三角肺癌邀请函长三角肺癌临床试验转化研究合作邀请函丨中国胸部肿瘤临床试验转化研究长三角模式探索样本库系列研究合作邀请函丨中国胸部肿瘤临床试验转化研究长三角模式探索长三角肺癌真实世界研究合作邀请函丨中国胸部肿瘤临床试验转化研究长三角模式探索
长三角肺癌基金系列长三角肺癌英才计划基金申请公告长三角肺癌新产品新技术研发-领航计划基金申请公告长三角肺癌新药研发-扬帆计划基金申请公告
Eur J Cancer（NCT05055232）Eur J Cancer Preclinical characterization and first-in-human, phase I trial of the novel ALK inhibitor dirozalkib in advanced non-small cell lung cancer Shun Lu（2026）
Lung Cancer（LAURA）Lung Cancer Osimertinib after definitive CRT in unresectable stage III EGFR-mutated NSCLC: safety outcomes from the phase III LAURA study Shun Lu（2026）
Lung Cancer（LAURA）Lung Cancer Osimertinib after definitive chemoradiotherapy in patients with unresectable stage III EGFR-mutated NSCLC: LAURA China cohort Shun Lu（2026）
Lancet Oncol（AENEAS2）Lancet Oncol Aumolertinib with or without chemotherapy in EGFR-mutated advanced non-small-cell lung cancer (AENEAS2): an open-label, multicentre, randomised, controlled, phase 3 trial Shun Lu, Zi-ming Li（2026）
Lung Cancer（MARIPOSA）Lung Cancer Overall survival for amivantamab plus lazertinib versus osimertinib as first-line treatment in Asian participants with EGFR-mutant advanced NSCLC: A MARIPOSA subset analysis Shun Lu（2026）
Lancet （HARMONi-6）Lancet Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in advanced squamous non-small-cell lung cancer (HARMONi-6): interim overall survival analysis of a randomised, double-blind, phase 3 trial Shun Lu（2026）
Cancer Cell（ChiCTR2300072141）Cancer Cell SYS6010, epidermal growth factor receptor-targeting antibody-drug conjugate for advanced non-small cell lung cancer: a phase 1 trial Shun Lu, Zi-ming Li（2026）
Lancet Oncol（NCT06166836 and NCT05379946）Lancet Oncol Ifebemtinib plus garsorasib in previously treated metastatic colorectal cancer with KRAS G12C mutation: a multicentre, randomised, phase 1b/2 trial Zheng-bo Song（2026）
Lancet Respir Med（NCT06166836 and NCT05379946）Lancet Respir Med Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer: a multicentre, single-arm expansion cohort from a phase 1b/2 trial Zheng-bo Song（2026）
Cancer Discov（NCT06667544）Cancer Discov Preclinical characterization and clinical activity of RNK08954，a highly selective and orally bioavailable KRAS G12D inhibitor Zheng-bo Song, Chun-wei Xu（2026）
J Thorac Oncol（AdvanTIG-302）J Thorac Oncol AdvanTIG-302: Phase 3 study of ociperlimab (Anti-TIGIT) + Tislelizumab (Anti-PD-1) versus pembrolizumab in untreated, locally advanced, unresectable, or metastatic non-small cell lung cancer with PD-L1 ≥50% Shun Lu（2026）
J Thorac Oncol（SKYSCRAPER-02C）J Thorac Oncol SKYSCRAPER-02C: A phase 3, randomized, double-blind, placebo-controlled study of atezolizumab plus carboplatin and etoposide with or without tiragolumab in patients with untreated extensive-stage SCLC Shun Lu（2026）
J Thorac Oncol（ACTIVE）J Thorac Oncol Aumolertinib as a switch therapy in osimertinib-intolerant NSCLC-The ACTIVE trial Shun Lu, Zi-ming Li（2026）
Lancet Reg Health West Pac（NCT04923945）Lancet Reg Health West Pac Efficacy and safety of savolitinib in Chinese patients with locally advanced or metastatic MET exon 14-mutated non-small cell lung cancer: final results of a confirmatory Phase 3b study Shun Lu（2026）
Lancet （SACHI）Lancet Savolitinib plus osimertinib versus chemotherapy for advanced, EGFR mutation-positive, MET-amplified non-small-cell lung cancer in China (SACHI): interim analysis of a multicentre, open-label, phase 3 randomised controlled trial Shun Lu（2026）
Transl Lung Cancer Res（GLORY）Transl Lung Cancer Res Long-term follow-up results from the GLORY study: phase II study of gumarontinib in East Asian patients with MET exon 14 skipping mutated non-small cell lung cancer Shun Lu, Yong-feng Yu（2025）
EClinicalMedicine（NCT03917043）EClinicalMedicine Safety, pharmacokinetic, pharmacodynamic, and efficacy properties of orally administered APG-2449 in patients with advanced ALK+ and ROS1+ non-small-cell lung cancer: a multicentre, open-label, single-arm phase 1 trial Zheng-bo Song（2025）
Clin Transl Oncol（ChiCTR2400087743）Clin Transl Oncol Intrapleural anti-PD-1 antibody for the treatment of advanced non-small cell lung cancer with malignant pleural effusion: a prospective, single-arm, single-center, phase I trial Yong Song, Tang-feng Lv, Ping Zhan, Yue Hao（2025）
Eur J Cancer（NCT04585035 and D1553-102）Eur J Cancer Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: a pooled analysis of phase 1/2 study Shun Lu, Zheng-bo Song, Zi-ming Li, Chun-wei Xu（2025）
Cancer Cell（NCT05154604）Cancer Cell TROP-2-targeted antibody-drug conjugate SHR-A1921 for advanced or metastatic solid tumors: a first-in-human phase 1 study Zheng-bo Song（2025）
Lancet Respir Med（POD1UM-304）Lancet Respir Med Retifanlimab versus placebo in combination with platinum-based chemotherapy in patients with first-line non-squamous or squamous metastatic non-small-cell lung cancer (POD1UM-304): a phase 3, multiregional, placebo-controlled, double-blind, randomised study Shun Lu（2025）
Lancet （HARMONi-6）Lancet Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (HARMONi-6): a randomised, double-blind, phase 3 trial Shun Lu（2025）
Nat Med（NCT05410145）Nat Med D3S-001 in advanced solid tumors with KRASG12C mutations: a phase 1 trial Shun Lu, Zheng-bo Song（2025）
N Engl J Med（MARIPOSA）N Engl J Med Overall survival with amivantamab-lazertinib in EGFR-mutated advanced NSCLC Shun Lu（2025）
Lancet Oncol（HORIZON-Lung）Lancet Oncol Trastuzumab rezetecan, a HER2-directed antibody–drug conjugate, in patients with advanced HER2-mutant non small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study Shun Lu, Zi-ming Li（2025）
Signal Transduct Target Tar（NCT04878016）Signal Transduct Target Tar A multicenter, randomized, double-blind, placebo-controlled phase 3 study of socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer Shun Lu（2025）
Signal Transduct Target Tar（NCT04566432）Signal Transduct Target Tar Noninvasive early identification of durable clinical benefit from immune checkpoint inhibition: a prospective multicenter study (NCT04566432) Shun Lu（2024）
J Thorac Oncol（NCT05116007）
J Thorac Oncol Ivonescimab combined with etoposide plus carboplatin as first-line treatment for extensive-stage small-cell lung cancer: results of a phase Ib clinical trial Shun Lu（2024）
J Thorac Oncol（PEARL）
J Thorac Oncol Durvalumab versus chemotherapy as first-line treatment for metastatic NSCLC with tumor PD-L1 expression ≥25%: results from the randomized phase 3 PEARL study Shun Lu（2024）
J Clin Oncol（NCT05301517）J Clin Oncol Efficacy and safety of roxadustat for anemia in patients receiving chemotherapy for nonmyeloid malignancies: a randomized, open-label, active-controlled phase III study Shun Lu（2024）
Ann Oncol（LAURA）Ann Oncol Osimertinib after definitive chemoradiotherapy in unresectable stage III epidermal growth factor receptor-mutated non-small-cell lung cancer: analyses of central nervous system efficacy and distant progression from the phase III LAURA study Shun Lu（2024）
Lancet Respir Med（NCT04923945）
Lancet Respir Med Savolitinib in patients in China with locally advanced or metastatic treatment-naive non-small-cell lung cancer harbouring MET exon 14 skipping mutations: results from a single-arm, multicohort, multicentre, open-label, phase 3b confirmatory study Shun Lu（2024）
Lung Cancer（IBIO-102）
Lung Cancer Befotertinib for patients with pretreated EGFR T790M mutated locally advanced or metastatic NSCLC: Final overall survival results from a phase 2 trial Shun Lu（2024）
Cancer Commun（AENEAS）
Cancer Commun Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated, EGFR-mutated, advanced non-small cell lung cancer: data from a randomized phase III trial (AENEAS) Shun Lu（2024）
Signal Transduct Target Ther（NCT04818333）
Signal Transduct Target Ther SHR-A1811 (antibody-drug conjugate) in advanced HER2 mutant non-small cell lung cancer: a multicenter, open-label, phase 1/2 study Shun Lu, Zi-ming Li, Zheng-bo Song（2024）
N Engl J Med（MARIPOSA）N Engl J Med Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC Shun Lu（2024）
Lancet Respir Med（D1553-102）Lancet Respir Med Garsorasib in patients with KRASG¹²C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 2 trial Shun Lu，Zi-ming Li（2024）
N Engl J Med（LAURA）N Engl J Med Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC Shun Lu（2024）
Clin Lung Cancer（NCT01970865 and NCT03909971）
Clin Lung Cancer Updated efficacy and safety of lorlatinib in a phase 2 study in Chinese patients with previously treated advanced ALK-positive non-small cell lung cancer Shun Lu（2024）
JAMA（Neotorch）
JAMA Perioperative toripalimab plus chemotherapy for patients with resectable non-small cell lung cancer：The Neotorch randomized clinical trial Shun Lu（2024）
eClinicalMedicine（ALTER-S006）
eClinicalMedicine Anlotinib as a maintenance treatment for advanced soft tissue sarcoma after first-line chemotherapy (ALTER-S006): a multicentre, open-label, single-arm, phase 2 trial Mei-yu Fang（2023）
Ther Adv Med Oncol（LIBRETTO-321）Ther Adv Med Oncol Patient-reported outcomes following selpercatinib treatment in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer and thyroid cancer, and RET-mutant medullary thyroid cancer in the phase II LIBRETTO-321 trial Shun Lu（2023）
Front Oncol（NCT04197076）Front Oncol An open, observational clinical study of neoadjuvant therapy in resectable stage III non-small cell lung cancer Shun Lu（2023）
Cancer Commun（ChiCTR2000029058）Cancer Commun A phase II study on Mefatinib as first-line treatment of patients with advanced non-small-cell lung cancer harboring uncommon EGFR mutations Yong Song（2023）
Signal Transduct Target Tar（NCT03019276 and NCT03972189）Signal Transduct Target Tar Efficacy, safety and pharmacokinetics of unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a phase I/II trial Shun Lu, Xing-xiang Xu（2023）
Int J Cancer（KEYNOTE-033）Int J Cancer KEYNOTE-033: Randomized phase 3 study of pembrolizumab vs docetaxel in previously treated, PD-L1-positive, advanced NSCLC Sheng-lin Ma（2023）
JCO Precis Oncol（LIBRETTO-321）JCO Precis Oncol Intracranial activity of selpercatinib in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer in the phase II LIBRETTO-321 trial Shun Lu（2023）
Nat Commun（NCT04448379）
Nat Commun Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer Zheng-bo Song，Li-yun Miao, Qian Wang, Chun-wei Xu（2023）
Lancet Respir Med（NCT04206072）Lancet Respir Med Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer: a multicentre, open-label, randomised phase 3 study Shun Lu（2023）
J Hematol Oncol（NCT04296994 and NCT05171790）
J Hematol Oncol First-in-human phase I/Ib study of QL1706(PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors Yi-ping Zhang（2023）
Lancet Respir Med（ORIENT-31）
Lancet Respir Med Sintilimab plus chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer with disease progression after EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): second interim analysis from a double-blind, randomised, placebo-controlled, phase 3 trial Shun Lu （2023）
eClinicalMedicine（GLORY）
eClinicalMedicine Gumarontinib in patient with non-small-cell lung cancer harbouring MET exon 14 skipping mutations：a multicentre, single-arm, open-label, phase 1b/2 trial Shun Lu, Yong-feng Yu（2023）
JTO Clin Res Rep（NCT04346914）JTO Clin Res Rep Efficacy and safety of anti-programmed death-ligand 1 monoclonal antibody socazolimab with carboplatin and etoposide for extensive-stage SCLC: Results from the phase 1b clinical trial Shun Lu, Zi-ming Li（2023）
J Thorac Oncol（NCT04585035）
J Thorac Oncol D1553（garsorasib）：a potent and selective inhibitor of KRAS G12C in patients with non-small cell lung cancer：Phase I study results Shun Lu, Yi-ping Zhang, Zi-ming Li, Zheng-bo Song，Chun-wei Xu（2023）
J Cancer Res Clin Oncol（NCT05427305）J Cancer Res Clin Oncol Bevacizumab biosimilar candidate TAB008 compared to Avastin® in patients with locally advanced, metastatic EGFR wild-type non-squamous non-small cell lung cancer: a randomized, double-blind, multicenter study Shun Lu（2023）
Ther Adv Med Oncol（CheckMate 870）Ther Adv Med Oncol An open label, safety study of Asian patients with advanced non-small-cell lung cancer receiving second-line nivolumab monotherapy (CheckMate 870) Shun Lu（2022）
Ther Adv Med Oncol（NCT02897479）Ther Adv Med Oncol Circulating tumour DNA biomarkers in savolitinib-treated patients with non-small cell lung cancer harbouring MET exon 14 skipping alterations: a post hoc analysis of a pivotal phase 2 study Shun Lu，Yong-feng Yu（2022）
JTO Clin Res Rep（NCT02897479）JTO Clin Res Rep Long-term efficacy, safety and subgroup analysis of savolitinib in Chinese patients with non-small cell lung cancers harboring MET exon 14 skipping alterations Shun Lu（2022）
Clin Cancer Res（NCT04091217）
Clin Cancer Res Atezolizumab plus bevacizumab in patients with unresectable or metastatic mucosal melanoma: a multicenter, open-label, single-arm phase 2 study Mei-yu Fang（2022）
Cancer Med（IMpower132）Cancer Med Results from the IMpower132 China cohort: Atezolizumab plus platinum-based chemotherapy in advanced non-small cell lung cancer Shun Lu（2022）
Front Immunol（NCT04197076）Front Immunol An open, observational, three-arm clinical study of 2-3 cycles of treatment as neoadjuvant therapy in operable locally advanced non-small cell lung cancer: an interim analysis Shun Lu（2022）
Ther Adv Med Oncol（LIBRETTO-321）Ther Adv Med Oncol Efficacy and safety of selpercatinib in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer: a phase II clinical trial (LIBRETTO-321) Shun Lu（2022）
J Thorac Oncol（IBIO-102）J Thorac Oncol Efficacy and safety of befotertinib (D-0316) in patients with EGFR T790M mutated non-small cell lung cancer that had progressed after prior EGFR TKI therapy: a phase 2, multicenter, single-arm, open-label study Shun Lu（2022）
Lancet Oncol（ORIENT-31）
Lancet Oncol Sintilimab plus bevacizumab biosimilar IBI305 and chemotherapy for patients with EGFR-mutanted nonsquamous non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor therapy (ORIENT-31)：First interim results from a randomized，double-blind，multicentre, phase 3 study Shun Lu（2022）
BMC Med（THALIA）
BMC Med Apatinib in patients with recurrent or metastatic thymic epithelial
tumor: a single-arm, multicenter, open-label, phase II trial Zheng-bo Song，Wen-xian Wang，Chun-wei Xu，Yi-ping Zhang（2022）
J Clin Oncol（AENEAS）
J Clin Oncol AENEAS: a randomized phase III trial of aumolertinib versus gefitinib as first-line therapy for locally advanced or metastatic non-small-cell lung cancer with EGFR exon 19 deletion or L858R mutations Shun Lu（2022）
Cancer J（RATIONALE 304）
Cancer J Examining the impact of tislelizumab added to chemotherapy on health-related quality-of-life outcomes in previously untreated patients with nonsquamous non-small cell lung cancer Shun Lu（2022）
J Thorac Oncol（NCT03909971）
J Thorac Oncol Lorlatinib for previously treated ALK-positive advanced non-small cell lung cancer: primary efficacy and safety from a phase 2 study in China Shun Lu（2022）
Oncologist（NCT03452150）
Oncologist Phase I trial of a third generation EGFR mutant-selective inhibitor (D-0316) in patients with advanced non-small cell lung cancer Shun Lu（2022）
BMC Med（EXPECT-II）
BMC Med Efficacy and safety of pyrotinib in advanced lung adenocarcinoma with HER2 mutations: a multicenter, single-arm, phase II trial Zheng-bo Song，Wen-xian Wang，Chun-wei Xu，Yi-ping Zhang，Shun Lu（2022）
J Thorac Oncol（CameL-sq）
J Thorac Oncol Camrelizumab plus carboplatin and paclitaxel as first-line treatment for advanced squamous non-small-cell lung cancer (CameL-sq): a phase 3 trial Xing-xiang Xu（2022）
J Thorac Oncol（APOLLO）
J Thorac Oncol Efficacy of aumolertinib (HS-10296) in patients with advanced EGFR T790M+NSCLC：updated post NMPA-approved results from the APOLLO registrational trial Shun Lu（2022）
Clin Cancer Res（EXPECT）
Clin Cancer Res Pyrotinib in HER2-amplified advanced non-small cell lung cancer: a prospective, multicenter, single-arm trial Zheng-bo Song，Wen-xian Wang，Chun-wei Xu，Yi-ping Zhang，Shun Lu（2022）
Transl Lung Cancer Res
Transl Lung Cancer Res Robotic-assisted thoracic surgery reduces perioperative complications and achieves a similar long-term survival profile as posterolateral thoracotomy in clinical N2 stage non-small cell lung cancer patients: a multicenter, randomized, controlled trial Qing-quan Luo（2021）
J Thorac Oncol（NCT03608007）
J Thorac Oncol Safety but limited efficacy of ensartinib in ROS1-positive non-small cell lung cancer: a single-arm, multicenter phase II study Shun Lu（2021）
Lancet Respir Med（NCT02897479）
Lancet Respir Med Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study Shun Lu（2021）
Transl Lung Cancer Res（NCT02976116）
Transl Lung Cancer Res Fruquintinib with gefitinib as first-line therapy in patients carrying EGFR mutations with advanced non-small cell lung cancer: a single-arm, phase II study Shun Lu（2021）
Ann Transl Med（TEINE, CTONG-0904）
Ann Transl Med Docetaxel maintenance therapy versus best supportive care after first-line chemotherapy with different dose docetaxel plus cisplatin for advanced non-small cell lung cancer (TFINE study, CTONG-0904): an open-label, randomized, phase III trial Shun Lu（2021）
J Thorac Oncol（RATIONALE 304）
J Thorac Oncol Tislelizumab plus chemotherapy as first-line treatment for locally advanced or metastatic nonsquamous non-small cell lung cancer (RATIONALE 304)：a randomized phase 3 trial Shun Lu（2021）
J Thorac Oncol（NCT03608007）
J Thorac Oncol Efficacy and safety of niraparib as maintenance treatment in patients with extensive-stage small cell lung cancer after first-line chemotherapy：a randomized， double-blind，phase 3 study Shun Lu（2021）
JAMA Oncol（RATIONALE 307）
JAMA Oncol Tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment for advanced squamous non-small-cell lung cancer：a phase 3 randomized clinical trial Shun Lu（2021）
Thorac Cancer（NCT04425681）
Thorac Cancer Osimertinib combined with bevacizumab for leptomeningeal metastasis from EGFR-mutation non-small cell lung cancer: a phase II single-arm prospective clinical trial Jing Cai, An-wen Liu（2021）
J Clin Oncol（NCT02605265）
J Clin Oncol Multicenter, randomized, phase III trial of neoadjuvant chemoradiation with capecitabine and irinotecan guided by UGT1A1 status in patients with locally advanced rectal cancer An-wen Liu（2020）
Lung Cancer（CheckMate-078）
Lung Cancer Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer: 2-year follow-up from a randomized, open-label, phase 3 study (CheckMate 078) Shun Lu（2020）
Clin Cancer Res（TRACELib001）
Clin Cancer Res Clonal architecture of EGFR mutation predicts the efficacy of EGFR-Tyrosine Kinase Inhitors in advanced NSCLC: a prospective multicenter study (NCT03059641) Shun Lu（2020）
Lung Cancer（FALUCA）
Lung Cancer A phase III, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer-the FALUCA study Shun Lu（2020）
Strahlenther Onkol
Strahlenther Onkol Timing of thoracic radiotherapy is more important than dose intensification in patients with limited-stage small cell lung cancer: a parallel comparison of two prospective studies Bing Xia（2020）
Transl Lung Cancer Res
Transl Lung Cancer Res Robot-assisted thoracoscopic surgery versus thoracotomy for c-N2 stage NSCLC: short-term outcomes of a randomized trial Qing-quan Luo（2019）
Cancer Manag Res（NCT01297101）
Cancer Manag Res Intercalated combination of chemotherapy and erlotinib for stage IIIA non-small-cell lung cancer: a multicenter, open-label, single-arm, phase II study Shun Lu（2019）
J Thorac Dis（ChiCTR1800020105）
J Thorac Dis Combination of apatinib and docetaxel in treating advanced non-squamous non-small cell lung cancer patients with wild-type EGFR: a multi-center, phase II trial Yong Song（2019）
J Thorac Dis
J Thorac Dis A phase II study of concurrent nab-paclitaxel/carboplatin combined with thoracic radiotherapy in locally advanced squamous cell lung cancer Sheng-lin Ma（2019）
Am J Clin Oncol (RE-CHALLENGE，CTONG1304)
Am J Clin Oncol Efficacy and safety of gefitinib as third-line treatment in NSCLC patients with activating EGFR mutations treated with first-line gefitinib followed by second-line chemotherapy：a single-arm, prospective, multicenter phase II study (RE-CHALLENGE, CTONG1304) Yong Song（2019）
J Clin Oncol（NCT02590965）
J Clin Oncol Randomized, double-blind, placebo-controlled, multicenter phase II study of fruquintinib after two prior chemotherapy regimens in Chinese patients with advanced nonsquamous non-small-cell lung cancer Shun Lu（2018）
J Thorac Oncol（NCT02088515）
J Thorac Oncol Nedaplatin plus docetaxel versus cisplatin plus docetaxel as first-line chemotherapy for advanced squamous cell carcinoma of the lung-a multicenter, open-label, randomized, phase III trial Shun Lu（2018）
Onco Targets Ther（NCT01523587）
Onco Targets Ther Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung Shun Lu（2018）
J Cancer（NCT02344979）
J Cancer A randomized controlled study of rhTPO and rhIL-11 for the prophylactic treatment of chemotherapy-induced thrombocytopenia in non-small cell lung cancer Shun Lu（2018）
Cancer Commun
Cancer Commun Epidermal growth factor receptor (EGFR) T790M mutation identified in plasma indicates failure sites and predicts clinical prognosis in non-small cell lung cancer progression during first-generation tyrosine kinase inhibitor therapy: a prospective observational study Shi-rong Zhang，Sheng-lin Ma（2018）
Sci Rep
Sci Rep Intercalating and maintenance gefitinib plus chemotherapy versus chemotherapy alone in selected advanced non-small cell lung cancer with unknown EGFR status Shun Lu（2017）
Ann Oncol（East Asia S-1）
Ann Oncol Randomized controlled trial of S-1 versus docetaxel in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy (East Asia S-1 Trial in Lung Cancer) Shun Lu（2017）
BMC Cancer（NCT01158144）
BMC Cancer A phase II study of endostatin in combination with paclitaxel, carboplatin, and radiotherapy in patients with unresectable locally advanced non-small cell lung cancer Sheng-lin Ma（2016）
J Thorac Oncol（NCT00912392）
J Thorac Oncol A multicenter, open-label, randomized phase II controlled study of rh-endostatin (endostar) in combination with chemotherapy in previously untreated extensive-stage small-cell lung cancer Shun Lu（2015）
Int J Radiat Oncol Biol Phys
Int J Radiat Oncol Biol Phys Phase 2 study of accelerated hypofractionated thoracic radiation therapy and concurrent chemotherapy in patients with limited-stage small-cell lung cancer Bing Xia（2015）
Onco Targets Ther
Onco Targets Ther Long-term results of a randomized controlled trial evaluating preoperative chemotherapy in resectable non-small cell lung cancer Qing-quan Luo，Shun Lu，Mei-lin Liao（2013）
Int J Hyperthermia
Int J Hyperthermia Intracavity hyperthermia in nasopharyngeal cancer: a phase III clinical study Sheng-lin Ma（2010）
Acta Pharmacol Sin
Acta Pharmacol Sin Phase II trial of gemcitabine plus cisplatin in patients with advanced non-small cell lung cancer Sheng-lin Ma（2010）
Lung Cancer
Lung Cancer Treatment of brain metastasis from non-small cell lung cancer with whole brain radiotherapy and gefitinib in a Chinese population Sheng-lin Ma（2009）
Chin Med J
Chin Med J Gemcitabine and cisplatin treatment over a 3-week versus a 4-week dosing schedule: a randomized trial conducted in Chinese patients with nonsmall cell lung cancer Mei-lin Liao（2008）
Chin J Cancer Res
Chin J Cancer Res The relationship between the pathological changes and response rate(RRR) in non-small cell lung cancer treated by neoadjuvant chemotherapy with mitomycin (MMC) vindesine (VDS) and cisplatin (DDP) combination Mei-lin Liao，Shun Lu（2000）
长三角肺癌沪浙苏赣四驱动一体化建设
临床试验-转化研究闭环式研究平台建设
1.基因多平台检测平台搭建（转化研究）
2.样本库平台搭建（转化研究）
3.罕见靶点类器官模型临床前研究平台搭建（临床试验+转化研究）
4.罕见靶点富集互联网医院平台搭建（临床试验+转化研究）
心路历程
心路历程1: 2019.12 长三角肺癌协作组成立
心路历程2: 2020.04 长三角肺癌协作组临床试验招募启动
心路历程3: 2020.07 长三角肺癌协作组青年医师巡讲团成立
心路历程4: 2021.01 长三角肺癌协作组青年博士团队成立
心路历程5: 2021.03 江苏省基层肺癌协作组成立
心路历程6: 2021.04 长三角肺癌基因多平台检测实验室揭牌
心路历程7: 2021.05 浙江省基层肺癌协作组成立
心路历程8：2021.07 长三角肺癌多中心研究样本库建立
心路历程9：2024.12 浙江省基层罕见肿瘤协作组成立
泛长三角肺癌系列（致敬经典，传承未来）
感恩并传承丨广东省人民医院吴一龙教授团队-中国肺癌原创临床研究阶段汇总
携手共赢丨香港中文大学威尔士亲王医院莫树锦教授团队-中国肺癌原创临床研究阶段汇总携手共赢丨中山大学肿瘤防治中心张力教授团队-中国肺癌原创临床研究阶段汇总携手共赢丨中国医学科学院肿瘤医院王洁教授团队-中国肺癌原创临床研究阶段汇总携手共赢丨吉林省肿瘤医院程颖教授团队-中国肺癌原创临床研究阶段总结成长的点滴丨解放军总医院第五医学中心刘晓晴教授团队临床试验汇总携手共赢丨湖南省肿瘤医院杨农张永昌教授团队临床试验汇总携手共赢丨河南省肿瘤医院马智勇王慧娟教授团队临床试验汇总携手共赢丨天津医科大学肿瘤医院黄鼎智教授团队临床试验汇总携手共赢丨福建省肿瘤医院黄诚林根教授团队临床试验汇总携手共赢丨山西白求恩医院张俊萍冯慧晶教授团队临床试验汇总携手共赢丨联勤保障部队第900医院余宗阳教授团队临床试验汇总
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临床1期
100 项与 埃万妥单抗 相关的药物交易
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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 | 2025-03-27 | |
| EGFR 外显子 19 缺失突变型非小细胞肺癌 | 美国 | 2024-08-19 | |
| EGFR外显子21替代突变非小细胞肺癌 | 美国 | 2024-08-19 | |
| 非小细胞肺癌 | 加拿大 | 2022-03-30 | |
| EGFR 20号外显子插入突变非小细胞肺癌 | 美国 | 2021-05-21 |
未上市
10 条进展最快的记录, 后查看更多信息
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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 | 2024-01-26 | |
| EGFR突变的非小细胞肺癌 | 申请上市 | 中国 | 2024-01-26 | |
| EGFR突变的非小细胞肺癌 | 申请上市 | 中国 | 2024-01-26 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 美国 | 2025-12-03 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 中国 | 2025-12-03 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 日本 | 2025-12-03 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 澳大利亚 | 2025-12-03 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 奥地利 | 2025-12-03 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 比利时 | 2025-12-03 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 巴西 | 2025-12-03 |
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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 |
|---|
N/A | 非小细胞肺癌 EGFR-mutant | 302 | (EGFR-mutant NSCLC) | 選膚淵顧鹹糧淵艱鹹選(願網製製醖淵夢簾醖夢) = 艱廠蓋餘淵觸構鑰製壓 簾餘壓窪鏇醖鹹鬱顧糧 (糧淵繭齋鑰顧廠繭廠遞 ) 更多 | 积极 | 2026-06-25 | |
(EGFR-mutant NSCLC) | 選膚淵顧鹹糧淵艱鹹選(願網製製醖淵夢簾醖夢) = 繭築範選築網築淵鹽鑰 簾餘壓窪鏇醖鹹鬱顧糧 (糧淵繭齋鑰顧廠繭廠遞 ) 更多 | ||||||
临床1/2期 | 94 | (cohort A) | 淵選襯鑰廠顧簾築積衊(艱獵遞襯願窪簾窪鏇觸) = 蓋鏇範醖構衊鑰築觸鏇 鬱淵鬱鹹壓淵觸鬱衊鬱 (鏇鹽顧襯製糧觸獵顧顧 ) 更多 | 积极 | 2026-06-10 | ||
(cohort B) | 淵選襯鑰廠顧簾築積衊(艱獵遞襯願窪簾窪鏇觸) = 淵鹹艱構獵製構製製簾 鬱淵鬱鹹壓淵觸鬱衊鬱 (鏇鹽顧襯製糧觸獵顧顧 ) 更多 | ||||||
临床1/2期 | RAS/BRAF基因野生型结直肠癌 RAS/BRAF wild-type | 73 | (CMS2) | 築夢膚廠憲遞糧顧構齋(糧築廠繭艱構憲觸夢築) = 衊齋壓淵餘鏇淵夢齋壓 觸膚蓋網齋壓鬱製憲憲 (鬱壓醖選壓築構艱構鹹 ) 更多 | 积极 | 2026-05-29 | |
(CMS4) | 築夢膚廠憲遞糧顧構齋(糧築廠繭艱構憲觸夢築) = 餘蓋窪獵醖鹹願積鹹顧 觸膚蓋網齋壓鬱製憲憲 (鬱壓醖選壓築構艱構鹹 ) 更多 | ||||||
临床1期 | 49 | 願襯獵繭願淵夢膚範襯(憲鹽築鏇鏇艱遞襯夢遞) = 醖繭構餘製餘廠窪範夢 淵構齋顧鏇願顧鹽鹹糧 (鬱鹽廠鏇醖憲繭鬱製製, 27.7 ~ NE) 更多 | 积极 | 2026-05-29 | |||
N/A | - | 15 | 膚醖網壓鑰願憲觸製憲(獵鑰範選製鹹壓積艱蓋) = 鹽積觸遞鬱窪網醖膚網 鬱製鹽醖觸網壓顧鹹獵 (壓膚鏇網壓鹽襯獵積窪 ) 更多 | 积极 | 2026-05-29 | ||
N/A | 4,909 | 網鏇鹹齋襯衊範襯蓋淵(範餘廠製範構淵構積齋): HR = 1.92 更多 | 积极 | 2026-05-29 | |||
immunotherapy +Chemo (IC) | |||||||
临床2期 | 70 | (advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve) | 選繭鏇構蓋淵蓋鹹餘鹽(憲襯蓋顧餘繭構鏇廠構) = 築繭鹹淵醖網糧製遞齋 簾艱餘製鹹鬱網鹹鬱範 (淵壓觸獵願襯願膚鑰積 ) 更多 | 积极 | 2026-05-29 | ||
(advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve) | 選繭鏇構蓋淵蓋鹹餘鹽(憲襯蓋顧餘繭構鏇廠構) = 鹽構構範鹹廠網積觸鏇 簾艱餘製鹹鬱網鹹鬱範 (淵壓觸獵願襯願膚鑰積 ) 更多 | ||||||
临床1/2期 | 102 | 獵範獵窪鹹鑰淵廠壓鏇(觸夢網夢齋網遞夢願簾) = 鹽範鬱襯壓顧鑰鹽積夢 構遞壓願蓋積蓋鑰顧齋 (襯顧廠遞網選簾獵積蓋, 37 ~ 57) 更多 | 积极 | 2026-05-29 | |||
临床2期 | 190 | 蓋網蓋憲蓋範築鑰廠膚(鏇鹽襯製選簾衊鏇遞願) = 窪範積糧觸範憲繭蓋壓 齋艱觸醖鹹餘製淵衊繭 (夢廠齋範範顧鹽獵鏇簾 ) 更多 | 积极 | 2026-05-29 | |||
N/A | 22 | Amivantamab monotherapy | 餘選鹹襯鏇選鏇鏇糧餘(選選鹽遞衊鑰憲繭簾鏇) = 壓壓鹹淵淵願衊蓋窪構 醖築壓膚襯鬱選蓋齋製 (廠願夢網觸觸選壓製簾, 36.1 ~ 80.9) 更多 | 积极 | 2026-05-29 | ||
Amivantamab monotherapy (classical EGFR) | 餘選鹹襯鏇選鏇鏇糧餘(選選鹽遞衊鑰憲繭簾鏇) = 壓範製選積窪鹹築築觸 醖築壓膚襯鬱選蓋齋製 (廠願夢網觸觸選壓製簾 ) 更多 |
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