Evaluating the Efficacy and Safety of Trilaciclib in Patients Receiving First-line Sintilimab Plus Chemotherapy for Advanced Driver Gene-negative Non-squamous Non-Small Cell Lung Cancer

开始日期2026-01-31

申办/合作机构

中国医科大学附属盛京医院

ChiCTR2600117342

/ Not yet recruiting临床1期IIT

Glumetinib combined with platinum-based chemotherapy for the treatment of MET-overexpressing locally advanced or metastatic non-small cell lung cancer: A single-arm, multicenter study

开始日期2026-01-24

申办/合作机构-

CTIS2025-521989-95-00

/ Not yet recruiting临床1/2期

Phase 1b/2 Trial of OMTX705, an Anti-Fibroblast Activation Protein Antibody-Drug Conjugate, in Combination with Carboplatin, Pemetrexed and Tislelizumab in Patients with Advanced/Metastatic Non-squamous Non-Small Cell Lung Cancer

开始日期2026-01-08

申办/合作机构

Oncomatryx Biopharma SL

100 项与培美曲塞二钾相关的临床结果

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100 项与培美曲塞二钾相关的转化医学

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100 项与培美曲塞二钾相关的专利（医药）

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3,769

项与培美曲塞二钾相关的文献（医药）

2026-03-01·LUNG CANCER

Combined intrathecal therapy via Ommaya reservoir and whole-brain radiotherapy improves survival in EGFR-mutant NSCLC patients with leptomeningeal metastases: a real-world cohort study

Article

作者: Wang, Haibo ; Li, Meifang ; Gao, Chongting ; Lin, Cheng ; Zhang, Wei ; Yu, Zongyang ; Lin, Dong ; Chen, Ying

OBJECTIVE:

This study aimed to evaluate the survival benefit of combined intrathecal treatment (IT) via Ommaya reservoir and whole-brain radiotherapy (WBRT) in EGFR-mutant non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases (LM).

METHODS:

We retrospectively analyzed EGFR-mutant NSCLC patients with LM diagnosed between January 2019 and September 2024. Patients were included if they had cytologically or radiologically confirmed LM and prior EGFR-TKI exposure. Clinical data, cerebrospinal fluid (CSF) profiles (cytology, biochemistry, molecular features), and treatment details were collected. Local therapies included WBRT (30-37.5 Gy in 10-15 fractions) and IT pemetrexed via Ommaya reservoir (10-20 mg weekly for 4 weeks, then bi-weekly for 2 months, followed by monthly maintenance). Overall survival (OS) was analyzed using Kaplan-Meier method and Cox regression. A prognostic nomogram was developed and validated.

RESULTS:

Among 200 included patients, the median OS was 12.3 months (95% CI: 10.8-13.8). Patients receiving local therapy (n = 149) had longer OS than those without (n = 51) (13.1 vs. 8.8 months; HR = 0.78, p = 0.001). The combination of IT and WBRT was associated with the best survival outcome (median OS 18.5 months). In CSF analysis, the initial cytology positivity rate was 74.4% (128/172), and normal lactate dehydrogenase (LDH) and chloride levels were associated with longer OS (p < 0.05). Multivariate analysis identified ECOG score, prior third-generation TKI, third-generation TKI plus anti-angiogenic therapy, and local therapy as independent prognostic factors.

CONCLUSION:

The combination of IT via Ommaya reservoir and WBRT may result in better survival in EGFR-mutant NSCLC patients with LM and represents a promising treatment strategy for this patient population.

2026-03-01·LUNG CANCER

Nintedanib as switch maintenance treatment in malignant pleural mesothelioma (NEMO): A double-blind randomized phase II trial (EORTC-08112-LCG)

Article

作者: Raskin, Jo ; Marreaud, Sandrine ; Hassani, Adam ; Abdel-Rahman, Omar ; Surmont, Veerle ; Taylor, Paul ; Jankowska, Petra ; Boone, Luc ; Dazzi, Claudio ; Zonato, Sabrina ; Young, Robin ; Toffart, Anne-Claire ; Popat, Sanjay ; O'Brien, Mary

INTRODUCTION:

Pleural mesothelioma (PM) is a lethal malignancy in which angiogenesis and progressive fibrosis drives disease. We evaluated angiogenesis inhibition using nintedanib monotherapy as switch maintenance in patients with PM that completed 4-6 cycles of prior platinum-pemetrexed chemotherapy. The trial was performed in parallel to the LUME-Meso trial in an era prior to routine immune checkpoint inhibitor use, when platinum-pemetrexed was standard of care.

METHODS:

This is a triple-blind, placebo-controlled, multicentric, randomized, phase II study. Patients with inoperable PM (all histologies) that completed 4-6 cycles of platinum-pemetrexed chemotherapy were randomized to nintedanib or placebo. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety.

RESULTS:

The trial was prematurely closed due to poor accrual after LUME-meso reported. 37 patients were randomized (18 to nintedanib, 19 to placebo). All analyses performed were descriptive. The median PFS was 3.4 months (95% CI: 2.83-5.82) and 4.6 months (95% CI: 3.65-13.17) for nintedanib and placebo arms, respectively (HR = 2.25, 95% CI: 1.07-4.73) with corresponding median OS of 13.1 months (95% CI: 10.22-26.02) and 38.9 months (95% CI: 18.66-NE) for nintedanib and placebo arms, respectively (HR = 2.38, 95% CI: 1.05-5.43). Two patients (11.1%) in the nintedanib arm experienced ≥ grade 3 treatment-related adverse events. Post progression treatment was balanced between arms but more patients in the placebo arm received immunotherapy (87% vs 54%).

CONCLUSIONS:

Descriptive analyses suggest switch maintenance nintedanib does not improve PFS nor OS compared to placebo. Efficacy of the placebo arm may be related to imbalanced immunotherapy usage.

2026-01-02·CANCER RESEARCH

Pharmacogenomic Characterization of a Large Cohort of Patient-Derived Cell Lines Identifies Therapeutic Strategies for Pleural Mesothelioma

Article

作者: Jaurand, Marie-Claude ; Blanquart, Christophe ; Zucman-Rossi, Jessica ; Lantuejoul, Sylvie ; Sequeiros, Ruth ; Meiller, Clément ; Wald, Ori ; Assié, Jean-Baptiste ; Lasvergnas, Julie ; Arnould, Maya ; Jean, Didier ; Al Zreibi, Charles ; Del Nery, Elaine ; Le Pimpec-Barthes, Françoise ; Pan, Long ; Stern, Esther ; Genovesio, Auguste ; Montagne, François

Abstract:

Pleural mesothelioma (PM) urgently requires effective treatments. This study aimed to identify potential therapies using a drug repurposing strategy in the context of the molecular heterogeneity of PM. We performed a multiomics study of a large cohort of patient-derived primary PM cell lines (n = 58) and conducted a multistep pharmacologic study starting with a large-scale drug screen with 1,327 compounds using 11 cell lines to select drugs of interest. Integrated multiomics analysis demonstrated that the molecular landscape of the cell line cohort recapitulates the main findings in tumors and revealed important features of PM. Large-scale drug screening identified 233 active compounds belonging to recurrent therapeutic classes. Subsequent validation of 35 compounds highlighted a subset of 12 compounds performing better than standard chemotherapy, including entinostat and fluvastatin, with therapeutic activity related to molecular sarcomatoid phenotype, BAP1 mutation, and YAP/TAZ activity. Importantly, both compounds displayed the same efficacy in 2D and 3D culture models, and a single treatment with entinostat improved survival in an immunocompetent mouse model compared with fluvastatin and standard cisplatin–pemetrexed chemotherapy, which showed similar antitumor effects. Strikingly, entinostat improved the efficacy of immunotherapy based on anti-PD-1 antibody. Combination of entinostat with anti-PD-1 even eradicated tumors in several mice and immunized them against retransplantation of tumor cells. Overall, the drug sensitivity data provided by this study represent a resource to facilitate future clinical investigations to improve the treatment of PM.

Significance::

Pharmacogenomic characterization of a cell line biobank provides a valuable resource on drug sensitivity in mesothelioma and identifies entinostat as a promising therapeutic option, particularly in combination with immune checkpoint inhibitors.

218

项与培美曲塞二钾相关的新闻（医药）

2026-01-26

·分子检测与治疗前沿

历史变革丨改变临床实践载入新英格兰医学史册的胸部肿瘤里程碑研究阶段汇总

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期临床试验病房临床试验汇总上海交通大学附属胸科医院肿瘤中心临床试验汇总时代背景赶潮儿1999-2009 1999年，中国国家食品药品监督管理总局CDA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 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EGR靶向药物阿美替尼获批上市，这是中国自主研发的第三代EGR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，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肺癌手术 N Engl J Med N Engl J Med Lobar or sublobar resection for peripheral stage IA non-small-cell lung cancer2023 化疗/抗血管生成 N Engl J Med N Engl J Med Chemotherapy with or without radiation therapy in limited small-cell carcinoma of the lung1987 N Engl J Med N Engl J Med Effects of concomitant cisplatin and radiotherapy on inoperable non-small-cell lung cancer1992 N Engl J Med N Engl J Med A randomized trial comparing preoperative chemotherapy plus surgery with surgery alone in patients with non-small-cell lung cancer1994 N Engl J Med N Engl J Med Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide1999 N Engl J Med N Engl J Med A randomized trial of postoperative adjuvant therapy in patients with completely resected stage II or IIIA non-small-cell lung cancer. Eastern Cooperative Oncology Group2000 N Engl J Med N Engl J Med Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer2002 N Engl J Med N Engl J Med Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer2002 N Engl J Med N Engl J Med A randomized trial of adjuvant chemotherapy with uracil-tegafur for adenocarcinoma of the lung2004 N Engl J MedIALT N Engl J Med Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer2005 N Engl J MedJBR.10 N Engl J Med Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer2005 N Engl J MedECOG4599 N Engl J Med Paclitaxel-carboplatin alone with bevacizumab for non-small-cell lung cancer 放疗 N Engl J Med N Engl J Med Effects of postoperative mediastinal radiation on completely resected stage II and stage III epidermoid cancer of the lung1986 N Engl J Med N Engl J Med A randomized trial of induction chemotherapy plus high-dose radiation versus radiation alone in stage III non-small-cell lung cancer1990 N Engl J Med N Engl J Med A meta-analysis of thoracic radiotherapy for small-cell lung cancer1992 N Engl J Med N Engl J Med Initial chemotherapeutic doses and survival in patients with limited small-cell lung cancer1993 N Engl J Med N Engl J Med Prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission. Prophylactic Cranial Irradiation Overview Collaborative Group1999 N Engl J Med N Engl J Med Prophylactic cranial irradiation in extensive small-cell lung cancer2007 N Engl J MedDeLLphi-304 N Engl J Med Tarlatamab in small cell lung cancer after platinum-based chemotherapy2025 靶向-EGR N Engl J Med N Engl J Med Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib2004 N Engl J Med N Engl J Med EGR mutation and resistance of non-small-cell lung cancer to gefitinib2005 N Engl J MedBR21 N Engl J Med Erlotinib in previously treated non-small-cell lung cancer2005 N Engl J Med N Engl J Med Erlotinib in lung cancer——Molecular and clinical predicotrs of outcome2005 N Engl J Med N Engl J Med Detection of mutations in EGR in circulating lung cancer cells2008 N Engl J MedIPASS N Engl J Med Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma2009 N Engl J Med N Engl J Med Screening for Epidermal Growth actor Receptor mutations in lung cancer2009 N Engl J MedNESJOG002 N Engl J Med Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGR2010 N Engl J MedAURA N Engl J Med AZD9291 in EGR inhibitor-resistant non-small-cell lung cancer2015 N Engl J MedNCT01526928 N Engl J Med Rociletinib in EGR-mutated non-small-cell lung cancer2015 N Engl J MedAURA3 N Engl J Med Osimertinib or platinum-pemetrexed in EGR T790M-positive lung cancer2016 N Engl J Med N Engl J Med Osimertinib in untreated EGR-mutated advanced non-small-cell lung cancer2017 N Engl J Med N Engl J Med Tracking the evolution of non-small-cell lung cancer2017 N Engl J MedADAURA N Engl J Med Osimertinib in resected EGR-mutated non-small-cell lung cancer2020 N Engl J Med N Engl J Med Overall survival with osimertinib in untreated, EGR-mutated advanced NSCLC2020 N Engl J MedADAURA N Engl J Med Osimertinib in resected EGR-mutated NSCLC2023 N Engl J Med2 N Engl J Med Osimertinib with or without chemotherapy in EGR-mutated advanced NSCLC2023 N Engl J MedPAPILLON N Engl J Med Amivantamab plus chemotherapy in NSCLC with EGR exon 20 insertions2023 N Engl J MedN Engl J Med Osimertinib after chemoradiotherapy in stage III EGR-mutated NSCLC2024 N Engl J MedMARIPOSAN Engl J Med Amivantamab plus lazertinib in previously untreated EGR-mutated advanced NSCLC2024 N Engl J MedOptiTROP-Lung04N Engl J Med Sacituzumab tirumotecan in EGR-TKI-resistant, EGR-mutated advanced NSCLC2025 靶向-ALK N Engl J MedPROILE 1001 N Engl J Med Anaplastic Lymphoma Kinase inhibition in non-small-cell lung cancer2010 N Engl J Med N Engl J Med EML4-ALK mutations in lung cancer that confer resistance to ALK inhibitors2010 N Engl J MedNCT00585195 N Engl J Med Crizotinib in ALK-rearranged inflammatory myofibroblastic tumor2010 N Engl J MedPROILE 1007 N Engl J Med Crizotinib versus chemotherapy in advanced ALK-positive lung cancer2013 N Engl J MedPROILE 1014 N Engl J Med irst-line crizotinib versus chemotherapy in ALK-positive lung cancer2014 N Engl J MedNCT01283516 N Engl J Med Ceritinib in ALK-rearranged non-small-cell lung cancer2014 N Engl J Med N Engl J Med Resensitization to crizotinib by the lorlatinib ALK resistance mutation L11982016 N Engl J MedALEX N Engl J Med Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer2017 N Engl J MedALTA-1L N Engl J Med Brigatinib versus crizotinib in ALK-positive non-small cell lung cancer2018 N Engl J MedCROWN N Engl J Med irst-line lorlatinib or crizotinib in advanced ALK-positive lung cancer2020 N Engl J MedALINAN Engl J Med Alectinib in resected ALK-positive non-small-cell lung cancer2024 靶向-ROS1 N Engl J MedPROILE 1001 N Engl J Med Anaplastic Lymphoma Kinase inhibition in non-small-cell lung cancer2010 N Engl J Med N Engl J Med Acquired resistance to crizotinib from a mutation in CD74-ROS12013 N Engl J MedNCT00585195 N Engl J Med Crizotinib in ROS1-rearranged non-small-cell lung cancer2014 N Engl J MedTRIDENT-1 N Engl J Med Repotrectinib in ROS1 fusion-positive non-small-cell lung cancer2024 靶向-MET N Engl J MedVISION N Engl J Med Tepotinib in non-small-cell lung cancer with MET exon 14 skipping mutations2020 N Engl J Med N Engl J Med Capmatinib in MET exon 14-mutated or MET-amplified non-small-cell lung cancer2020 靶向-RET N Engl J Med N Engl J Med Efficacy of selpercatinib in RET fusion-positive non-small-cell lung cancer2020 N Engl J MedLIBRETTO-431 N Engl J Med irst-line selpercatinib or chemotherapy and pembrolizumab in RET fusion-positive NSCLC2023 靶向-HER2 N Engl J MedDESTINY-Lung01 N Engl J Med Trastuzumab deruxtecan in HER2-mutant non-small-cell lung cancer2021 N Engl J MedBeamion LUNG-1 N Engl J Med Zongertinib in previously treated HER2-mutant non-small-cell lung cancer2025 N Engl J MedSOHO-01 N Engl J Med Sevabertinib in advanced HER2-mutant non-small-cell lung cancer2025 靶向-KRAS N Engl J Med N Engl J Med Mutational activation of the K-ras oncogene. A possible pathogenetic factor in adenocarcinoma of the lung1987 N Engl J MedCodeBreaK100 N Engl J Med KRAS G12C inhibition with sotorasib in advanced solid tumors2020 N Engl J MedCodeBreaK100 N Engl J Med Sotorasib for lung cancers with KRAS p.G12C mutation2021 N Engl J Med N Engl J Med Acquired resistance to KRAS G12C inhibition in cancer2021 N Engl J MedKRYSTAL-1 N Engl J Med Adagrasib in non-small-cell lung cancer harboring a KRAS G12C mutation2022 N Engl J MedNCT04449874 N Engl J Med Single-agent divarasib(GDC-6036) in solid tumors with a KRAS G12C mutation2023 靶向-BRA N Engl J MedNCT01524978 N Engl J Med Vemurafenib in multiple nonmelanoma cancers with BRA V600 mutations2015 靶向-NTRK N Engl J Med N Engl J Med Efficacy of larotrectinib in TRK fusion-positive cancers in adults and children2018 靶向-NRG1 N Engl J MedeNRGy N Engl J Med Efficacy of zenocutuzumab in NRG1 fusion-positive cancer2025 靶向-GR N Engl J Med N Engl J Med 免疫-PD-1/PD-L1 N Engl J Med N Engl J Med Safety, activity, and immune correlates of anti-PD-1 antibody in cancer2012 N Engl J Med N Engl J Med Safety and activity of anti-PD-L1 antibody in patients with advanced cancer2012 N Engl J MedKEYNOTE-001 N Engl J Med Pembrolizumab for the treatment of non-small-cell lung cancer2015 N Engl J Med (CheckMate 017) N Engl J Med Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer2015 N Engl J MedCheckMate 057 N Engl J Med Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer2015 N Engl J MedKEYNOTE-024 N Engl J Med Pembrolizumab versus chemotherapy for PD-L1 positive non-small-cell lung cancer2016 N Engl J MedCheckMate 026 N Engl J Med irst-line nivolumab in stage IV or recurrent non-small-cell lung cancer2017 N Engl J Med N Engl J Med Durvalumab after chemoradiotherapy in stage III non-small-cell lung cancer2017 N Engl J MedKEYONTE 189 N Engl J Med Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer2018 N Engl J Med (KEYONTE 407) N Engl J Med Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer2018 N Engl J MedIMpower133 N Engl J Med irst-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer2018 N Engl J MedIMpower150 N Engl J Med Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC2018 N Engl J MedCheckMate 227 N Engl J Med Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden2018 N Engl J Med N Engl J Med Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC2018 N Engl J Med N Engl J Med Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer2018 N Engl J MedCheckMate 159 N Engl J Med Neoadjvant PD-1 blockade in resectable lung cancer2018 N Engl J MedCheckMate 227 N Engl J Med Nivolumab plus ipilimumab in advanced non-small-cell lung cancer2019 N Engl J Med N Engl J Med Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC2020 N Engl J MedCheckMate 816 N Engl J Med Neodjuvant nivolumab plus chemotherapy in resectable lung cancer2022 N Engl J MedKEYONTE 671 N Engl J Med Perioperative pembrolizumab for early-stage non-small-cell lung cancer2023 N Engl J MedNADIM IIN Engl J Med Perioperative nivolumab and chemotherapy in stage III non-small-cell lung cancer2023 N Engl J MedAEGEANN Engl J Med Perioperative durvalumab for resectable non-small-cell lung cancer2023 N Engl J MedKEYONTE 671 N Engl J Med Talatamab for patients with previously treated small-cell lung cancer2023 N Engl J MedCheckMate 77T N Engl J Med Perioperative nivolumab in resectable lung cancer2024 N Engl J MedADRIATICN Engl J Med Durvalumab after chemoradiotherapy in limited-stage small-cell lung cancer2024 20 N Engl J MedCheckMate 816 N Eng J Med Overall survival with neoadjuvant nivolumab plus chemotherapy in lung cancer2025 读书笔记丨历史回顾肺癌靶向免疫治疗研究进展里程碑研究-第一季读书笔记丨历史回顾肺癌靶向免疫治疗研究进展里程碑研究-第二季读书笔记丨历史回顾肺癌靶向免疫治疗研究进展里程碑研究-第三季读书笔记丨历史回顾肺癌靶向免疫治疗研究进展里程碑研究-第四季食管癌 N Engl J Med N Engl J Med Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus1992 N Engl J Med N Engl J Med A comparison of multimodal therapy and surgery for esophageal adenocarcinoma1996 N Engl J Med N Engl J Med Chemoradiotherapy followed by surgery compared with surgery alone in squamous-cell cancer of the esophagus1997 N Engl J Med N Engl J Med Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer1998 N Engl J Med N Engl J Med Extended transthoracic resection compared with limited transhiatal resection for adenocarcinoma of the esophagus2002 N Engl J MedMAGIC N Engl J Med Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer N Engl J Med N Engl J Med Capecitabine and oxaliplatin for advanced esoph-agogastric cancer2008 N Engl J Med N Engl J Med Preoperative chemoradiotherapy for esophageal or junctional cancer2012 N Engl J MedNCT00937456 N Engl J Med Hybrid minimally invasive esophagectomy for esophageal cancer2019 N Engl J MedCheckMate 577 N Engl J Med Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer2021 N Engl J MedCheckMate 648 N Engl J Med Nivolumab combination therapy in advanced esophageal squamous-cell carcinoma2022读书笔记丨胸部肿瘤之食管癌重要临床研究阶段汇总胸腺上皮肿瘤 N Engl J Med N Engl J Med 读书笔记丨胸部肿瘤之胸腺上皮肿瘤重要临床研究阶段汇总间皮瘤 N Engl J Med N Engl J Med 读书笔记丨胸部肿瘤之间皮瘤重要临床研究阶段汇总整理者

临床1期

2026-01-26

·BioSpace

AstraZeneca’s Tagrisso® and Calquence® Among First Oncology Treatments Granted Accelerated Access Through Ontario’s FAST Program

Ontario is the first province to fund Tagrisso for patients with non-small cell lung cancer, and Calquence for patients with previously untreated mantle cell lymphoma MISSISSAUGA, ON , Jan. 23, 2026 /CNW/ - AstraZeneca Canada is pleased to announce that Tagrisso® (osimertinib) and Calquence® (acalabrutinib tablets) are now publicly funded in Ontario and are among the first therapies to receive accelerated access through the province's new Funding Accelerated for Specific Treatments (FAST) program. With the introduction of FAST, the Government of Ontario has taken a significant step toward accelerating access to cancer medicines – demonstrating its commitment to putting patients first and embracing innovation so that life-changing treatments can reach those who need them, faster than ever. "For every Ontarian facing a cancer diagnosis, timely access to high-quality treatment can make all the difference," said Sylvia Jones, Deputy Premier and Minister of Health. "Through the FAST program, our government is accelerating access to life-saving therapies including, Tagrisso and Calquence, bringing hope, peace of mind, and transformative care to those who need it most." Following recent positive reimbursement recommendations from the Canadian Drug Agency (CDA-AMC), Tagrisso is publicly reimbursed in Ontario for the treatment of patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum based chemoradiation therapy. 1 A validated test is required to identify EGFR mutation-positive status prior to treatment. 1 "For people living with EGFR‑mutated Stage III NSCLC, timely access to targeted treatment after chemoradiation can be life-changing," said Shem Singh, Executive Director Lung Cancer Canada. "Ontario's decision to enable access to therapies through the FAST program offers renewed hope for patients and families, and underscores how provincial leadership can shorten the path to the right care. We're hopeful other provinces will move quickly so timely, equitable access becomes a reality for patients across Canada." Following Ontario's public reimbursement of Tagrisso for this indication, it is now listed on the public formularies of Quebec and Saskatchewan. Calquence is also now publicly reimbursed in Ontario in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous stem cell transplant. 2 "MCL is a rare and often aggressive disease most commonly diagnosed in older adults who are especially vulnerable to delays in care," said Antonella Rizza, CEO, Lymphoma Canada. "We're grateful that the Ontario Government is leading the way in driving systemic change to enable quicker access to evidence-based treatments and helping reduce unnecessary wait times for patients in need." FAST includes select, high priority cancer drugs with demonstrated benefit, including therapies like Tagrisso and Calquence, approved through Project Orbis, an international partnership that involves Health Canada and is designed to give cancer patients faster access to promising treatments. This helps shorten the time between regulatory approval, reimbursement, and patient access. "This first-of-its kind program underscores the Government of Ontario's bold leadership in accelerating patient access to much-needed cancer medicines," said Gaby Bourbara, President, AstraZeneca Canada. "Public funding of Tagrisso and Calquence through FAST shows what is possible when regulators, payers, clinicians, and industry work together. We commend the province's commitment to innovation in access and remain dedicated to partnering across Canada to expand timely and equitable access to life‑changing treatments." About Tagrisso Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. The treatment is approved in Canada for the following indications: as adjuvant therapy after tumour resection in patients with stage IB-IIIA NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations; for the first-line treatment of patients with locally advanced (not amenable to curative therapies), or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations); in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced (not amenable to curative therapies) or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations; for the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy; and has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit, for the treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum based chemoradiation therapy. About Calquence Calquence is a second-generation, highly selective inhibitor of Bruton's tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion. In Canada, Calquence (acalabrutinib tablets) is approved in combination with venetoclax for patients with previously untreated chronic lymphocytic leukemia (CLL); as monotherapy or in combination with obinutuzumab for patients with previously untreated CLL; as monotherapy for the treatment of patients with CLL who have received at least one prior therapy; in combination with bendamustine and rituximab for patients with previously untreated MCL who are ineligible for autologous stem cell transplant; and as monotherapy for the treatment of patients with MCL who have received at least one prior therapy. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. In Canada, the company employs more than 2,650 people and was recently named one of Canada's Top 100 Employers for the third consecutive year. Together, AstraZeneca's R&D Hub and the Alexion, AstraZeneca Rare Disease Development Hub – both based in Mississauga, Ontario – are leading more than 110 global and Canadian clinical studies in areas such as breast, lung and prostate cancer, COPD, chronic kidney disease, and rare disease. Visit for more information. References: 1. Canada's Drug Agency. Reimbursement recommendation: Osimertinib (Tagrisso). Canadian Journal of Health Technologies, Vol. 5, No. 9, September 2025. Available at: 2. Canada's Drug Agency. Reimbursement recommendation: Acalabrutinib (Calquence). Canadian Journal of Health Technologies, Vol. 5. No. 10. November 2025. Available at: SOURCE AstraZeneca Canada Inc.

上市批准加速审批临床研究

2026-01-25

·医学界肿瘤频道

袁双虎教授：从“无药可用”到“有药可及”，首款国产肺癌HER2 ADC药物瑞康曲妥珠单抗纳入医保，让患者用得上、用得起创新药

*仅供医学专业人士阅读参考我国首个原研肺癌HER2 ADC药物瑞康曲妥珠单抗成功纳入国家医保目录，填补了HER2突变非小细胞肺癌（NSCLC）靶向治疗的医保空白，为患者带来更可及的治疗曙光。在当前肺癌分子分型时代下，每个明确驱动基因的发现都伴随着靶向治疗的一次突破。然而，在这一演进过程中，HER2突变NSCLC患者的治疗之路却格外漫长而艰难。尽管该突变早在2004年已被识别，但近二十年来，临床实践中仍面临着“有靶无药”的困境。患者常接受“化疗联合免疫治疗”的方案，但客观缓解率（ORR）普遍在30%左右，中位无进展生存期（PFS）也仅维持在4-6个月之间，疗效远远落后于EGFR、ALK等拥有成熟靶向药物的突变类型[1,2]。患者肿瘤负荷难以得到有效控制，疾病进展后更缺乏有效的后续治疗选择。在这一关键转折点上，中国创新药物研发迎来了重要突破。瑞康曲妥珠单抗作为我国首个自主研发的肺癌HER2 ADC药物，通过与肿瘤细胞表面的HER2蛋白结合，内吞进入细胞，在溶酶体内释放毒素，诱导肿瘤细胞周期阻滞和凋亡，同时存在较强的旁路杀伤效应，实现对HER2突变肿瘤的高效杀伤。该药物的临床价值已获得国家药品监督管理局（NMPA）的认可，曾9次被纳入突破性治疗药物程序（CDE），并在近期成功进入国家医保目录。值此之际。医学界肿瘤频道特邀请中国科学技术大学附属第一医院袁双虎教授进行访谈，探讨此次医保纳入为临床实践、患者获益及行业创新带来的深远影响。图1. 2025年国家医保目录中的瑞康曲妥珠单抗 Q：能否请您分享HER2突变NSCLC的流行病学特征、疾病生物学特性等核心信息？同时结合近年领域内关键研究成果，谈谈其为HER2突变晚期NSCLC治疗格局带来的重要变革，以及当前临床仍存在的未被满足需求？袁双虎教授 HER2突变在NSCLC的检出率约在2%–4%，常见于腺癌、非/轻度吸烟者及女性患者群体。常见变异以exon20插入（如A775_G776insYVMA等）为主，但也包括点突变与跨膜/近膜区改变，这些亚型在生物学行为与药物敏感性上存在异质性[3,4]。从临床表型来看，携带HER2突变的NSCLC通常表现出较为侵袭性的生物学行为。一是基线及疾病进程中，中枢神经系统（CNS）转移发生率偏高，二是肿瘤多呈“冷肿瘤”特征（总体突变负荷较低、免疫细胞浸润与PD-L1表达较低），因此对单药免疫治疗的疗效有限。上述疾病特征综合决定了临床上需优先考虑能够快速深度缩瘤，并具备优秀的全身控制能力的治疗选择，尤其是在存在颅内病灶或高肿瘤负荷的患者中。近年来，随着靶向治疗的进展，HER2突变NSCLC的治疗格局逐步从传统化疗转向以酪氨酸激酶抑制剂（TKI）和ADC为主导的精准治疗。其中，ADC药物的崛起尤为瞩目，以瑞康曲妥珠单抗为代表的HER2 ADC，在既往化疗失败的HER2突变NSCLC中呈现了远超以往疗法的ORR与PFS[5,6]。HORIZON-Lung研究结果显示，在既往接受过系统治疗的HER2突变患者中，瑞康曲妥珠单抗的ORR超过了70%，中位PFS达到了11.5个月。同时，在小分子靶向药物方面，多项早期/中期临床数据表明，一些高度选择性的口服HER2-TKI在HER2突变经治和初治患者中均具有一定的疗效，例如宗艾替尼[7]。此外，对于伴有颅内病灶的患者，部分新型TKI亦报告了较好的颅内应答。尽管取得了上述实质性进展，HER2突变NSCLC仍存在若干尚未满足的临床需求，亟待通过进一步研究来解决，包括检测与分层问题，需要统一并普及高质量的二代测序报告与解读；治疗序列与联合策略的证据仍需加强，例如ADC能否前移至一线、如何优化联合方案，需要更多随机三期试验验证；以及耐药机制复杂，后续治疗选择存在空白，需要建立规范的再活检策略来指导后续药物开发。图2. HORIZON-Lung研究中瑞康曲妥珠单抗的中位PFS Q：基于HORIZON-Lung研究的突破性数据，瑞康曲妥珠单抗已获批HER2突变晚期NSCLC ≥2线治疗适应症，且顺利纳入国家医保目录。请您谈谈这些进展对中国HER2突变NSCLC患者的临床价值与实际获益意义？袁双虎教授 HORIZON-Lung研究的结果，使瑞康曲妥珠单抗成为我国HER2突变晚期NSCLC患者一项的里程碑式治疗选择。研究显示[5,6]，在既往接受过系统治疗的患者中，该药的ORR达到约73%。更值得关注的是，在以往被视为治疗难度更高的亚组中，例如既往使用过HER2-TKI的患者，或基线存在脑转移的患者，瑞康曲妥珠单抗仍表现出稳定而可靠的疗效，且总体安全性良好，没有出现新的不可控不良反应。这些结果不仅证明了其在二线及以上治疗阶段的重要价值，也为未来在更早治疗序列或联合方案中的探索奠定了坚实基础。这一突破最终促成了瑞康曲妥珠单抗获批上市，并成功纳入国家医保目录，使其临床意义进一步放大。医保覆盖大幅降低了患者获得治疗的经济负担，使更多符合条件的患者能够及时接受有效药物，避免因为费用问题而中断治疗或退回化疗等效果较弱的方案。同时，医保准入也会推动以HER2为代表的分子检测在临床中的规范化开展，使更多患者能够在疾病早期就被准确识别，从而接受精准治疗，形成良性循环。此外，瑞康曲妥珠单抗的获批与医保进入，对于我国本土ADC药物研发具有重要示范意义。其成功案例不仅验证了我国自主研发的ADC药物可以在重大未满足领域取得实质性突破，也促进了国内科研机构和企业在抗体工程、连接子技术和靶点策略上的深入探索。随着更多真实世界数据的积累，其经验还将进一步推动国内HER2突变NSCLC的诊疗体系向更加规范、更加精准的方向发展。总体而言，瑞康曲妥珠单抗的上市与医保准入，不仅填补了HER2突变晚期NSCLC在后线治疗上的长期空白，也通过疗效、安全性、可及性和体系推动等多重维度，为我国患者带来了切实而多层面的临床价值。 Q：当前HER2 ADC与TKI药物在HER2突变晚期NSCLC领域进展迅猛，能否结合最新循证证据与临床实践经验，为我们解读如何为这类患者精准个体化施策，制定最优治疗方案？袁双虎教授为患者制定个体化方案，需要基于精准的诊断和全面的临床评估。二代测序（NGS）应为必需检测，报告需明确HER2突变的具体亚型，并同时分析可能的共突变，这些信息对预测药物敏感性和预后至关重要。同时，应进行包括脑部增强磁共振在内的全面分期评估。在治疗策略上，一线治疗方面，目前对是否将ADC作为一线常规选择，尚缺乏大规模随机对照生存证据，因此在无明确临床试验可选情况下，HER2突变晚期NSCLC患者一线治疗可参照驱动基因阴性患者，化疗+免疫是主要可选方案。在二线及以上治疗方面，基于HORIZON-Lung研究的优秀结果，在既往接受过铂类±免疫的患者中，ADC应被视为首选系统治疗。在局部治疗方面，对于局灶性或寡发脑转移，或可先行脑部放疗/手术切除，以控制局部病灶；对于广泛脑转移或软脑膜受累患者，应优先选择具有颅内活性的全身治疗方案，如瑞康曲妥珠单抗。在特殊情形的考量上，对于既往使用过HER2-TKI的患者，研究显示ADC在TKI经治者中仍有高应答率，支持从TKI切换为ADC。对于老年或合并多种疾病的患者，需根据体能状态、器官功能仔细评估治疗强度，权衡获益与风险。在ADC或TKI治疗进展后，应尽可能通过再活检或液体活检解析耐药机制，并基于分子结果选择参加临床试验或靶向性后续治疗。若无法获得分子证据，则可考虑化疗、原方案再挑战或最佳支持治疗。 Q：新型ADC药物在肺癌治疗中彰显突破疗效，展望未来，您认为在适应人群精准筛选、治疗线序优化、联合治疗模式探索（如与放疗、免疫、靶向药物联用）、耐药机制解析等方向，需如何深化研究以进一步提升新型ADC药物的临床应用价值？袁双虎教授未来研究不应局限于识别HER2突变本身，而需将共突变谱、HER2蛋白表达水平、肿瘤微环境特征等多维生物标志物纳入前瞻性分析，建立复合生物标志物模型以预测ADC的疗效与毒性。对ADC耐药早期生物标志物的识别尤为重要。以HORIZON-Lung等研究为基础，开展随机化Ⅲ期试验，比较ADC与现行一线治疗，以明确是否应将ADC前移为常规一线或成为联合策略的组成部分。联合治疗模式的理性探索同样也是一个重点方向。例如，ADC+免疫检查点抑制剂，原理在于ADC可能诱导免疫原性细胞死亡，从而“加热”HER2突变这类“冷肿瘤”，与免疫治疗产生协同效应；ADC+放疗（局部放疗），关注协同的生物学基础（放疗促进抗原释放）及潜在的肺毒性叠加，在早期需要严格的肺功能、影像与症状监测方案；ADC+选择性TKI，探索序贯或短期联合，可能提升疗效，但需谨慎评估毒性叠加。最后，探索ADC与小分子药物的耐药机制，基于机制的后续策略可能包括，更换载药机制的ADC、联合治疗等。总结随着瑞康曲妥珠单抗完成从临床试验数据到临床实践应用、医保准入的完整转化，HER2突变晚期NSCLC的治疗格局已实现历史性跨越。医保准入不仅意味着治疗费用的实质性降低，更代表着国家层面对这一患者群体治疗需求的重视与回应。这一突破不仅提升了创新药物的可及性，更为肺癌精准治疗模式的推广奠定了制度基础，将推动中国肺癌诊疗体系向更加规范化、精准化的方向演进。未来，随着真实世界证据的积累和治疗方案的持续优化，有望为更多肺癌患者带来长期生存获益，推动肿瘤防治水平的整体提升。专家简介袁双虎教授中国科学技术大学教授、博士生导师临床医学院书记附属第一医院（安徽省立医院）副院长安徽省肿瘤医院院长/合肥离子医学中心院长 PTCOG空间分割粒子治疗专委会共同主席中国肿瘤放射治疗联盟（CRTOG)执行主委中国医师协会肿瘤多学科诊疗专委会副主委中国抗癌协会常务理事安徽省癌症研究会理事长从事肿瘤临床与转化研究，擅长质子治疗、生物精准放疗与个体化综合诊治，成果多次入选国际指南，荣获国家及省部科技进步奖十余次，入选中组部“万人计划” 科技创新领军人才、科技部中青年科技创新领军人才、国务院特殊津贴专家、泰山学者特聘专家等。参考文献： [1]Yang S, et al. Exon 20 YVMA insertion is associated with high incidence of brain metastasis and inferior outcome of chemotherapy in advanced non-small cell lung cancer patients with HER2 kinase domain mutations. Transl Lung Cancer Res. 2021 Feb;10(2):753-765. [2]Wang Y, et al. Outcomes of Pemetrexed-based chemotherapies in HER2-mutant lung cancers. BMC Cancer. 2018 Mar 27;18(1):326. [3]Nützinger J, et al. Management of HER2 alterations in non-small cell lung cancer - The past, present, and future. Lung Cancer. 2023. 186: 107385. [4]Trillo AP, et al. HER2 in Non-Small Cell Lung Cancer (NSCLC): Evolution of the Therapeutic Landscape and Emerging Drugs-A Long Way to the Top. Molecules. 2025. 30(12): 2645. [5]Li Z, et al. 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. Lancet Oncol. 2025;26(4):437-446. [6]Lu S, et al. Abstract CT009: SHR-A1811, a HER2-directed antibody-drug conjugate (ADC), in advanced HER2-mutant non-small cell lung cancer (NSCLC): Updated phase 2 results from HORIZON-Lung. AACR 2025 [7]Sanjay P, et al. Zongertinib as First-Line Treatment in Patients with Advanced HER2-Mutant NSCLC: Beamion LUNG-1. 2025 ESMO. LBA74. *此文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场。更多医疗资讯，点击“阅读原文”查看

抗体药物偶联物免疫疗法突破性疗法申请上市临床申请

100 项与培美曲塞二钾相关的药物交易

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适应症	国家/地区	公司	日期
ALK阳性非小细胞肺癌	美国	Avyxa Pharma	2025-10-03
局部晚期非鳞状非小细胞肺癌	美国	Avyxa Pharma	2024-06-28
恶性胸膜间皮瘤	美国	Avyxa Pharma	2024-06-28
转移性非鳞状非小细胞肺癌	美国	Avyxa Pharma	2024-06-28
非鳞状非小细胞肺癌	美国	Avyxa Pharma	2024-06-28
复发性非鳞状非小细胞肺癌	美国	Avyxa Pharma	2024-06-28

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌 III期	临床3期	美国	Eli Lilly & Co.	2008-09-01
非小细胞肺癌IIIB期	临床3期	美国	Eli Lilly & Co.	2008-09-01
非小细胞肺癌IIIB期	临床3期	中国	Eli Lilly & Co.	2008-09-01
非小细胞肺癌IIIB期	临床3期	阿根廷	Eli Lilly & Co.	2008-09-01
非小细胞肺癌IIIB期	临床3期	澳大利亚	Eli Lilly & Co.	2008-09-01
非小细胞肺癌IIIB期	临床3期	比利时	Eli Lilly & Co.	2008-09-01
非小细胞肺癌IIIB期	临床3期	巴西	Eli Lilly & Co.	2008-09-01
非小细胞肺癌IIIB期	临床3期	加拿大	Eli Lilly & Co.	2008-09-01
非小细胞肺癌IIIB期	临床3期	法国	Eli Lilly & Co.	2008-09-01
非小细胞肺癌IIIB期	临床3期	德国	Eli Lilly & Co.	2008-09-01

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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


ESMO_ASIA2025	N/A	肾盂输尿管移行细胞癌转移 EGFR exon 20 insertion \| MTAP loss	1	Amivantamab+pemetrexed-based chemotherapy (EGFR exon 20 insertion + MTAP loss + Metastatic upper tract urothelial carcinoma)	襯鹽願窪鹽遞襯遞繭鏇(醖醖網餘積選壓衊鏇齋) = 選獵遞網製網壓鑰鏇齋齋遞鹹齋艱蓋蓋餘鹹廠 (壓積製壓廠艱願願膚積 )	积极	2025-12-05
ChiCTR2100047017 (ESMO_ASIA2025)	临床2期	EGFR+	18	Aumolertinib + intrathecal pemetrexed	範艱艱遞醖鏇糧醖糧鬱(鑰觸鏇製鏇醖網觸窪醖) = The most common adverse event was myelosuppression (n=5; 27.8%), which reversed after symptomatic treatment. 糧鹽製網餘網網齋鏇廠 (糧糧衊築鹹繭醖獵廠築 )	积极	2025-12-05
NCT04211090 (CAP-BRAIN, Pubmed \| EClinicalMedicine)	临床2期	晚期非小细胞肺癌一线	45	Camrelizumab + Pemetrexed + Carboplatin	窪遞選餘範積選壓選獵(觸齋鏇簾鏇鑰鹽艱糧廠) = 襯鏇遞製積積顧選繭範鏇壓鬱膚鑰繭壓構醖繭 (廠製壓醖選窪衊遞築廠, 40.9 ~ 73.0) 更多	积极	2025-12-01
NCT03132532 (CTgov)	临床2期	复发性非小细胞肺癌 \| 不可切除的非小细胞肺癌	20	Quality-of-Life Assessment+Etoposide+Carboplatin+Pemetrexed+Paclitaxel+cisplatin (Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT))	鹹獵壓獵鑰醖獵夢鑰繭 = 鬱鹽淵餘願齋憲膚艱餘鏇壓鏇鬱齋餘餘膚網窪 (願選廠壓鏇襯艱積積願, 廠範構積壓鏇襯網齋簾 ~ 鹽鹽衊蓋蓋艱齋遞蓋衊) 更多	-	2025-11-25
NCT03132532 (CTgov)	临床2期	复发性非小细胞肺癌 \| 不可切除的非小细胞肺癌	20	Quality-of-Life Assessment+Carboplatin+Paclitaxel (Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT))	鹹獵壓獵鑰醖獵夢鑰繭 = 鹽製鬱齋壓積網範艱繭鏇壓鏇鬱齋餘餘膚網窪 (願選廠壓鏇襯艱積積願, 繭鹽齋糧廠蓋鹹壓衊構 ~ 繭選觸願鏇範顧膚築構) 更多	-	2025-11-25
ESMO2025	N/A	软脑膜转移性恶性肿瘤	150	NGS-guided double dose of targeted therapy combined with intrathecal pemetrexed chemotherapy	構繭壓醖淵糧積願夢觸(艱窪衊淵積醖築壓衊齋) = The most common AEs were myelosuppression (48.0%) and elevation of hepatic aminotransferases (25.3%). 顧餘選鏇築範艱繭觸製 (蓋範艱製鑰繭構製淵淵 )	积极	2025-10-17
ESMO2025	N/A	EGFR突变的非小细胞肺癌二线 EGFR mutation	241	Osimertinib + Osimertinib/pemetrexed (EGFR common mutations + advanced NSCLC)	蓋網衊顧襯糧廠鏇願鹹(壓觸範鏇壓鬱壓鬱襯遞) = 顧淵鏇遞築網繭製願齋憲襯遞蓋鏇夢衊蓋夢願 (積鬱壓憲遞襯遞繭構鬱, 8.1 ~ 11.1) 更多	不佳	2025-10-17
NCT05289908 (Pubmed \| J Neurooncol)	临床1/2期	软脑膜转移性恶性肿瘤巩固 \| 一线 \| 维持	34	Intrathecal pemetrexed (MTD group)	壓艱糧願糧壓齋襯選遞(製觸醖積餘衊淵築積廠) = 15% (5/34) 餘鏇膚衊憲觸構淵鬱衊 (鑰鏇繭齋淵糧範夢鑰壓 ) 更多	积极	2025-07-23
KCT0008608 (ASCO2025)	临床2期	晚期胆道癌	30	Pemetrexed/Oxaliplatin (PemOx)	膚顧憲範簾餘憲餘鏇淵(醖衊蓋糧醖獵築構蓋襯) = 醖醖窪積顧鏇獵廠廠窪鬱製窪選餘網餘鑰膚蓋 (選範壓鬱糧醖襯壓選選 ) 更多	不佳	2025-05-30
ASCO2025	N/A	宫颈癌二线 SCC \| CA-125	11	Pemetrexed + Bevacizumab	鹹選遞鏇醖顧顧鹽觸積(醖餘蓋顧齋積築淵遞遞) = Grade III reactions included anemia (18.2%) 醖鏇襯衊簾顧顧餘夢鬱 (憲遞艱鬱蓋製積餘糧廠 ) 更多	积极	2025-05-30
ASCO2025	N/A	卵巢癌二线	15	Pemetrexed	淵窪繭襯蓋觸繭鑰膚構(窪鑰糧艱衊廠鹽憲廠淵) = grade 1-2 anemia in 6 patients (40%) 齋構餘獵壓醖觸憲繭餘 (獵夢衊繭鹹鏇蓋願積構 ) 更多	积极	2025-05-30