The aims of this study are to determine the potential clinical benefits (in terms of PFS, objective response and OS) of add-on systemic chemotherapy (pemetrexed+carboplatin/cisplatin) to first-line osimertinib treatment among the poor prognostic group of metastatic EGFR-mutant lung adenocarcinoma, i.e. failure of plasma ctDNA EGFR mutant clearance at week 3 after osimertinib treatment

开始日期2025-05-01

申办/合作机构

香港大学

NCT06829459

/ Recruiting临床3期

A Randomized, Controlled, Open-label Phase III Clinical Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients With MET Amplification and/or Overexpression After Resistance to EGFR-TKIs

The is a randomized, controlled, open-label Phase III clinical study to evaluate the efficacy and safety of glumetinib combined with osimertinib mesylate versus platinum-based doublet chemotherapy in non-small cell lung cancer( NSCLC) patients with MET amplification and/or overexpression after resistance to EGFR-TKIs..
Approximately 350 NSCLC patients with MET amplification and/or overexpression after previous treatment with EGFR-TKIs are planned to be enrolled. After patients sign the informed consent form (ICF), those who are eligible for enrollment after screening examinations will be randomized to the investigational group or the control group in a 1:1 ratio by the central randomization system (IWRS).

开始日期2025-04-03

申办/合作机构

上海津曼特生物科技有限公司

NCT06908772

/ Not yet recruiting临床2/3期

A Multicenter Phase II/III Clinical Study on the Efficacy and Safety of Glumetinib Combined With Osimertinib as First-Line Treatment in Non-Small Cell Lung Cancer Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression

To evaluate the efficacy and safety of glumetinib combined with osimertinib as the first-line treatment for locally advanced or metastatic NSCLC.

开始日期2025-04-01

申办/合作机构

上海津曼特生物科技有限公司

100 项与甲磺酸奥希替尼相关的临床结果

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100 项与甲磺酸奥希替尼相关的转化医学

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100 项与甲磺酸奥希替尼相关的专利（医药）

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4,527

项与甲磺酸奥希替尼相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Comparison of first-generation EGFR-TKIs combined with low-dose bevacizumab versus osimertinib in untreated advanced EGFR-mutated NSCLC

Article

作者: Xu, Yingqi ; Zhong, Runbo ; Jin, Hongping ; Lou, Yuqing ; Zhong, Hua ; Zhang, Yidan ; Xu, Jianlin

BACKGROUND:

This study aimed to compare the efficacy of first-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) combined with low-dose bevacizumab(7.5 mg/kg) versus osimertinib as first-line treatment in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC).

MATERIALS AND METHODS:

A total of 161 patients with advanced NSCLC harboring EGFR mutations, who received first-line treatment at Shanghai Chest Hospital between July 2017 and July 2023, were enrolled in this study. Among them, 78 patients were treated with a combination of first-generation EGFR-TKIs and bevacizumab (7.5 mg/kg), constituting the bevacizumab plus TKI (A + T) group. The remaining 83 patients received osimertinib monotherapy (80 mg daily), forming the osimertinib group.

RESULTS:

The objective response rate (ORR) was 65.4% (51/78) in the A + T group and 68.7% (57/83) in the osimertinib group (p = 0.657). Despite the potentially poorer baseline conditions of patients in the osimertinib group, the median progression-free survival (PFS) was 16.59 months (95% CI: 14.39-18.80) in the A + T group compared to 16.82 months (95% CI: 13.76-19.89) in the osimertinib group (p = 0.792). Preliminary overall survival (OS) analysis indicated a median OS of 51.75 months (95% CI: 41.63-61.86) in the A + T group versus 35.55 months (95% CI: 22.32-48.77) in the osimertinib group (p = 0.010), however, the OS data are not yet mature.

CONCLUSION:

Although osimertinib remains the preferred first-line treatment for advanced NSCLC with EGFR mutations, combining first-generation EGFR-TKIs with low-dose bevacizumab may be a viable alternative for certain patients.

2025-12-01·LUNG

Update 2025: Management of Non‑Small-Cell Lung Cancer

Review

作者: Jeon, Hyein ; Wang, Shuai ; Gill, Harjot ; Song, Junmin ; Cheng, Haiying

Abstract:

Lung cancer remains the leading cause of cancer-related mortality worldwide. Since 2024, the non–small-cell lung cancer (NSCLC) landscape has undergone a transformative shift, driven by 11 FDA approvals. Recent advances in molecular profiling, targeted therapies, and immunotherapies have revolutionized NSCLC management, ushering in an era of personalized treatment with improved patient outcomes. The increased adoption of low-dose computed tomography (LDCT) for screening has enhanced early detection, enabling intervention at more curable stages. Molecular diagnostics now play a pivotal role in guiding treatment strategies, with actionable genomic alterations (AGAs) informing the use of EGFR, ALK, ROS1, KRAS, NRG1, and other targeted inhibitors in both early and advanced settings. For instance, targeted therapies are increasingly being integrated into early-stage management, with adjuvant osimertinib for EGFR-mutated NSCLC and alectinib for ALK-positive NSCLC demonstrating substantial survival benefits. Immunotherapy, particularly immune checkpoint inhibitors, has become a cornerstone of treatment for AGA-negative NSCLC, either as monotherapy or in combination with chemotherapy, and is increasingly being utilized in the perioperative setting. Furthermore, emerging therapies such as bispecific antibodies, antibody–drug conjugates (ADCs), and novel immunotherapeutic agents show promise in addressing resistance mechanisms and improving outcomes in advanced-stage disease. Although new challenges arise, the evolving NSCLC treatment paradigm continues to prioritize precision medicine, offering hope for prolonged survival and enhanced quality of life for patients.

2025-12-01·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

作者: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

2,195

项与甲磺酸奥希替尼相关的新闻（医药）

13 小时之前

·肿瘤界

2025 ASCO | 10余项中国研究入选！肺癌口头报告摘要标题一文速览

点击蓝字关注我们前言作为肿瘤学领域的国际盛会，ASCO年会每年都吸引着来自世界各地的顶尖学者、临床专家与科研团队，共同分享最新研究成果、探讨创新疗法、展望未来趋势。随着2025年ASCO年会完整日程的正式公布，全球肿瘤学界的目光再次聚焦于此。在此，本文特整理了本届ASCO大会中肺癌领域入选的Oral Abstract Session（口头报告专场）、Rapid Oral Abstract Session（快速口头报告专场）以及Clinical Science Symposium（临床科学研讨会）的研究，让我们先一睹为快！Oral Abstract Session口头报告专场摘要号：2004研究英文名称：A phase II study of asandeutertinib (TY-9591) in advanced NSCLC patients with EGFR-positive mutations and brain metastases.研究中文名称：asandeutertinib（TY-9591）在EGFR阳性突变和脑转移的晚期NSCLC患者中的II期研究讲者：邢力刚 | 中国医学科学院肿瘤医院摘要号：3001研究英文名称：Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with driver genomic alterations (GA) outside of classic EGFR mutations.研究中文名称：BL-B01D1（iza-bren）治疗携带经典EGFR突变以外驱动基因改变的局部晚期或转移性NSCLC的I期临床研究：一种靶向EGFR×HER3的双特异特异性抗体驱动药物偶联物（ADC）的评估讲者：杨云鹏 | 中山大学肿瘤防治中心摘要号：3002研究英文名称：Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic small cell lung cancer (SCLC).研究中文名称：iza-bren（BL-B01D1），一种EGFR x HER3双特异性ADC，在局部晚期或转移性小细胞肺癌（SCLC）患者中的I期研究讲者：黄岩 | 中山大学肿瘤防治中心摘要号：LBA8000研究英文名称：Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816.研究中文名称：CheckMate 816研究中可切除NSCLC患者新辅助纳武利尤单抗联合化疗的总生存期分析讲者：Patrick M. Forde | Trinity St. James's Cancer Institute, Trinity College Dublin摘要号：8001研究英文名称：Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.研究中文名称：NeoADAURA研究：可切除EGFR突变NSCLC术前新辅助奥希替尼±化疗对比单纯化疗讲者：Jamie E. Chaft | Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY; Department of Medicine, Weill Cornell Medical College摘要号：8002研究英文名称：Lung cancer diagnosis rates (LCDR) in lung cancer screening (LCS) and incidental pulmonary nodule (IPN) cohorts in the Mississippi Delta.研究中文名称：密西西比三角洲地区肺癌筛查与偶然发现肺结节队列中的肺癌诊断率研究讲者：Raymond U. Osarogiagbon | Baptist Cancer Center, Multidisciplinary Thoracic Oncology Program摘要号：8003研究英文名称：SWOG/NRG S1914: Randomized phase III trial of induction/consolidation atezolizumab + SBRT versus SBRT alone in high risk, early-stage NSCLC.研究中文名称：SWOG/NRG S1914研究：高危早期NSCLC诱导/巩固期阿替利珠单抗联合SBRT对比单纯SBRT的随机III期试验讲者：Megan Eileen Daly | Department of Radiation Oncology, University of California Davis Comprehensive Cancer Center摘要号：LBA8004研究英文名称：R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy.研究中文名称：R-ALPS研究：贝莫苏拜单抗（TQB2450）联合或不联合安罗替尼维持治疗经同步或序贯放化疗后无进展的局部晚期不可切除（III期）NSCLC患者的随机、双盲、安慰剂对照、多中心III期临床试验讲者：陈明 | 中山大学肿瘤防治中心摘要号：LBA8005研究英文名称：Randomized phase II trial investigating whether atezolizumab after chemoradiotherapy (CRT) prolongs survival in limited stage (LS) small cell lung cancer (SCLC).研究中文名称：局限期小细胞肺癌（LS-SCLC）化放疗后使用阿替利珠单抗是否延长生存的随机II期试验讲者：Bjorn Henning Gronberg | Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology and Department of Oncology, St. Olavs Hospital摘要号：8006研究英文名称：Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial.研究中文名称：III期IMforte研究：芦比替定联合阿替利珠单抗作为广泛期小细胞肺癌（ES‑SCLC）患者一线维持治疗的主要结果讲者：Luis G. Paz-Ares | Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc摘要号：8007研究英文名称：A phase 2 dose expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced small cell lung cancer.研究中文名称：ZG006（一种靶向CD3/DLL3/DLL3的三特异性T细胞接合器）单药治疗晚期SCLC的II期剂量扩展研究讲者：艾星浩 | 上海交通大学医学院附属胸科医院摘要号：LBA8008研究英文名称：Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of Ph3 DeLLphi-304.研究中文名称：Tarlatamab对比化疗（CTx）二线（2L）治疗SCLC：III期DeLLphi-304研究的主要分析讲者：Charles M Rudin | Fiona and Stanley Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center摘要号：8500研究英文名称：First-line adagrasib (ADA) with pembrolizumab (PEMBRO) in patients (pts) with advanced/metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) from the phase 2 portion of the KRYSTAL-7 study.研究中文名称：II期KRYSTAL‑7研究：adagrasib联合帕博利珠单抗一线治疗晚期/转移性KRASG12C突变NSCLC患者讲者：Pasi A. Jänne | Department of Medical Oncology, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8501研究英文名称：TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC).研究中文名称：TROPION‑Lung02研究：Dato-DXd联合帕博利珠单抗±铂类化疗一线治疗晚期NSCLC讲者：Benjamin Philip Levy | Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine摘要号：LBA8502研究英文名称：CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC): A randomized, single-blind, multicenter phase 3 study.研究中文名称：CAMPASS研究：贝莫苏拜单抗联合安罗替尼对比帕博利珠单抗一线治疗晚期NSCLC：一项随机、单盲、多中心III期研究讲者：韩宝惠 | 上海交通大学医学院附属胸科医院摘要号：8503研究英文名称：Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab.研究中文名称：zipalertinib对既往接受过含或不含埃万妥单抗铂类化疗的EGFR外显子20插入突变NSCLC患者的疗效评估讲者：Helena Alexandra Yu | Memorial Sloan Kettering Cancer Center摘要号：8504研究英文名称：SOHO-01: Safety and efficacy of BAY 2927088 in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) who were pretreated but naïve to HER2-targeted therapy or had not received any treatment for advanced disease.研究中文名称：SOHO-01研究：BAY 2927088治疗既往接受过治疗但未接受HER2靶向治疗或未接受过任何治疗的晚期HER2突变NSCLC患者的疗效和安全性研究讲者：Herbert H. Loong | 香港中文大学摘要号：LBA8505研究英文名称：Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study.研究中文名称：赛沃替尼联合奥希替尼对比化疗治疗EGFR-TKI治疗进展后EGFR突变伴MET扩增的晚期NSCLC：来自III期随机SACHI研究结果讲者：陆舜 | 上海市胸科医院摘要号：8506研究英文名称：Patritumab deruxtecan (HER3-DXd) in resistant EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) after a third-generation EGFR TKI: The phase 3 HERTHENA-Lung02 study.研究中文名称：Patritumab-deruxtecan（HER3-DXd）治疗第三代EGFR-TKI治疗后耐药的EGFR突变晚期NSCLC：III期HERTHENA-Lung02研究讲者：莫树锦 | 香港中文大学摘要号：8507研究英文名称：Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study.研究中文名称：芦康沙妥珠单抗（sac-TMT）治疗既往接受过治疗的晚期EGFR突变NSCLC：来自OptiTROP-Lung03随机研究的结果讲者：张力 | 中山大学肿瘤防治中心Rapid Oral Abstract Session快速口头报告专场摘要号：8009研究英文名称：Association of post-surgical MRD status with neoadjuvant ctDNA dynamics, genomic mutations, and clinical outcomes in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.研究中文名称：III期AEGEAN研究：术后MRD状态与新辅助ctDNA动态、基因突变特征及可切除NSCLC患者预后的相关性分析讲者：Martin Reck | Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research摘要号：LBA8010研究英文名称：Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: Updated survival and biomarker analyses from CheckMate 77T.研究中文名称：CheckMate 77T研究：可切除NSCLC患者围手术期纳武利尤单抗对比安慰剂治疗的生存及生物标志物更新分析讲者：Mariano Provencio | Hospital Universitario Puerta de Hierro摘要号：8011研究英文名称：ctDNA-based MRD detection in unresectable NSCLC undergoing curatively intended chemoradiotherapy and durvalumab.研究中文名称：在接受根治性放化疗及度伐利尤单抗治疗的不可切除NSCLC患者中基于ctDNA的MRD检测讲者：Aslaug Helland | University of Oslo, Clinical Medicine摘要号：8012研究英文名称：The preliminary results of a randomized phase II trial evaluating induction toripalimab plus chemotherapy followed by concurrent chemoradiotherapy and consolidation toripalimab in bulky unresectable stage III non-small-cell lung cancer (InTRist).研究中文名称：InTRist研究：评估特瑞普利单抗联合诱导化疗，随后同步放化疗及特瑞普利单抗巩固治疗用于巨大不可切除的III期NSCLC的随机II期试验的初步结果讲者：Yu Wang | 中国医学科学院肿瘤医院摘要号：8013研究英文名称：Safety and efficacy of lurbinectedin plus atezolizumab as second-line treatment for advanced small-cell lung cancer: Results of the 2SMALL phase 1/2 study (NCT04253145).研究中文名称：I/II期2SMALL研究：芦比替定联合阿替利珠单抗作为晚期NSCLC二线治疗的疗效和安全性讲者：Santiago Ponce Aix | Hospital Universitario 12 de Octubre and Oncosur Foundation摘要号：8014研究英文名称：Clinical and molecular characteristics of early progressors (EPs) and long-term progression-free survivors (LTPs) from the phase 3 ADRIATIC trial of consolidation durvalumab (D) vs placebo (P) after concurrent chemoradiotherapy (cCRT) in limited-stage small-cell lung cancer (LS-SCLC).研究中文名称：III期ADRIATIC研究：同步放化疗后巩固度伐利尤单抗对比安慰剂治疗用于LS-SCLC患者中早期进展者与长期无进展生存者的临床与分子特征讲者：David Allen Barbie | Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8015研究英文名称：Alectinib as neoadjuvant treatment in potentially resectable stage III ALK-positive NSCLC: Final analysis of ALNEO phase II trial (GOIRC-01-2020-ML42316).研究中文名称：阿来替尼作为新辅助治疗用于潜在可切除III期ALK阳性NSCLC的ALNEO II期研究最终分析（GOIRC-01-2020-ML42316）讲者：Marcello Tiseo | Department of Medicine and Surgery, University of Parma; Medical Oncology Unit, University Hospital of Parma; Gruppo Oncologico Italiano di Ricerca Clinica, GOIRC摘要号：8016研究英文名称：Efficacy and safety of nivolumab plus ipilimumab for patients with pre-treated type B3 thymoma and thymic carcinoma: Results from the EORTC-ETOP NIVOTHYM phase II trial.研究中文名称：纳武利尤单抗联合伊匹木单抗治疗经治的B3型胸腺瘤和胸腺癌患者的疗效与安全性：EORTC-ETOP NIVOTHYM II期研究结果讲者：Nicolas Girard, MD | Institut du Thorax Curie Montsouris, Institut Curie, Paris, and UVSQ, Paris Saclay University摘要号：8017研究英文名称：Integrin αVβ3-targeted imaging for identification of lung cancer and mapping of lymph-node metastases: A prospective, multicenter, self-controlled phase 3 trial (TRIIL study).研究中文名称：靶向整合素αVβ3的成像用于肺癌的识别和淋巴结转移的定位：一项前瞻性、多中心、自身对照的III期试验（TRIIL研究）讲者：Rongxi Wang | 北京协和医院摘要号：8512研究英文名称：Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met protein–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced EGFR-mutated (MT) non-squamous (NSQ) non-small cell lung cancer (NSCLC): Results from a phase 1 study.研究中文名称：靶向c-Met的抗体偶联药物（ADC）Telisotuzumab adizutecan（ABBV-400；Temab-A）治疗晚期EGFR突变非鳞NSCLC的I期研究结果讲者：David Ross Camidge | University of Colorado Cancer Center摘要号：8513研究英文名称：Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO).研究中文名称：II期SAVANNAH研究随机亚组结果：赛沃替尼联合奥希替尼对比赛沃替尼联合安慰剂的疗效及中枢神经系统结果分析讲者：Benjamin Philip Levy | Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine摘要号：8514研究英文名称：Phase 3 study of benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC).研究中文名称：贝莫苏拜单抗联合化疗，随后序贯联合安罗替尼一线治疗局部晚期或转移性鳞状NSCLC的III期研究讲者：石远凯 | 中国医学科学院肿瘤医院摘要号：8515研究英文名称：Plasma-guided adaptive first-line chemoimmunotherapy for non-small cell lung cancer (NSCLC).研究中文名称：血浆引导的NSCLC一线个体化化免治疗探索讲者：Julia K. Rotow | Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8516研究英文名称：Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer.研究中文名称：NSCLC患者免疫化疗时间与无进展生存期及总生存期相关性的随机试验讲者：张永昌 | 湖南省肿瘤医院摘要号：8517研究英文名称：Hypoxia-responsive CEA CAR-T cells therapy for relapsed or refractory non-small cell lung cancer: A single-arm, open-label, phase I trial.研究中文名称：缺氧反应型CEA CAR-T细胞疗法治疗复发或难治性NSCLC：一项单臂、开放标签、I期试验讲者：魏双 | 华中科技大学同济医学院附属同济医院摘要号：8518研究英文名称：S1900E: A phase II study examining impact of co-mutations on sotorasib for previously treated stage IV/recurrent KRAS G12C mutated (MUT) non-squamous (Non-sq) non-small cell lung cancer (NSCLC) (ECOG-ACRIN led Lung-MAP Sub-study).研究中文名称：S1900E研究：评估合并突变对sotorasib治疗经治的KRAS G12C突变IV期/复发性非鳞NSCLC疗效影响的II期研究（ECOG-ACRIN主导Lung-MAP子研究）讲者：Sukhmani Kaur Padda | Fox Chase Cancer Center/Temple Health摘要号：8519研究英文名称：Safety and efficacy of olomorasib + immunotherapy in first-line treatment of patients with KRAS G12C-mutant advanced NSCLC: Update from the LOXO-RAS-20001 trial.研究中文名称：Olomorasib联合免疫治疗用于KRAS G12C突变晚期NSCLC一线治疗的疗效和安全性：LOXO-RAS-20001研究更新讲者：Konstantin H. Dragnev | Dartmouth Cancer Center摘要号：8520研究英文名称：Sosimerasib monotherapy in patients with previously treated KRAS G12C–mutated non-small cell lung cancer: Primary results of a phase 2 study.研究中文名称：Sosimerasib单药治疗KRAS G12C突变NSCLC：II期研究的主要结果讲者：王洁 | 中国医学科学院肿瘤医院摘要号：LBA8671研究英文名称：PRAGMATICA-LUNG (SWOG S2302): A prospective, randomized study of ramucirumab plus pembrolizumab versus standard of care for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer.研究中文名称：Practicala-LUNG研究（SWOG S2302）：雷莫芦单抗联合帕博利珠单抗对比标准治疗用于既往接受过免疫治疗的IV期或复发性NSCLC患者的前瞻性随机研究讲者：Konstantin H. Dragnev | Dartmouth Cancer CenterClinical Science Symposium临床科学研讨会摘要号：8509研究英文名称：First-in-class PD-1/IL-2 bispecific antibody IBI363 in patients (Pts) with advanced immunotherapy-treated non-small cell lung cancer (NSCLC).研究中文名称：首创新药PD-1/IL-2双特异性抗体IBI363治疗经免疫治疗的晚期NSCLC患者讲者：周建娅 | 浙江大学医学院附属第一医院摘要号：8510研究英文名称：Efficacy and safety of MHB088C, a novel B7-H3-targeted ADC, in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC): Subgroup analysis from a phase 1/2 multicenter study.研究中文名称：一项评估新型靶向B7-H3的ADCMHB088C治疗复发ES-SCLC的疗效与安全性的I/II期多中心研究的亚组分析讲者：周彩存 | 同济大学附属东方医院摘要号：8511研究英文名称：First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line treatment (1L) in unresectable malignant mesothelioma.研究中文名称：首个评估BNT327/PM8002联合化疗作为不可切除恶性胸膜间皮瘤一线治疗的II期试验的疗效及安全性结果报告讲者：程颖 | 吉林省肿瘤医院备注：如有遗漏或任何问题，请给我们留言~声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：医脉通胸部肿瘤编辑：lagertha审核：南星

抗体药物偶联物临床结果ASCO会议临床1期

23 小时之前

·医药魔方

药械合作的“来时路”：一款创新药物的伴随诊断极致布局

2025年2月，强生公司的埃万妥单抗注射液（锐珂®）（Amivantamab, Rybrevant®）在中国获批上市：与卡铂和培美曲塞联合给药，用于经检测确认携带EGFR 20号外显子插入（exon20ins）突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。4月底，埃万妥单抗的第二个适应症在华获批：联合卡铂和培美曲塞，治疗携带EGFR exon19del或L858R，经EGFR-TKI治疗进展的晚期非鳞状NSCLC患者。同年的4月、5月，埃万妥单抗的两款原研伴随诊断（组织和血浆）依次获得NMPA批准。而这两个用途，均搭载于制造业单项冠军企业艾德生物的同一款产品——人类10基因突变联合检测试剂盒（可逆末端终止测序法）。这款试剂盒，曾在2018年首次通过NMPA创新医疗器械审查通道获批上市：作为治疗肺癌和肠癌关键靶向药物的伴随诊断，已经服务中国临床七个年头。本次获批是增加了EGFR exon20ins的CDx标签，以及第二个全新用途——血浆检测。埃万妥单抗何许人也埃万妥单抗是一款双特异性抗体，可以同时靶向结合EGFR和MET的胞外域，施加双重抗癌机制：它阻断配体结合，诱导EGFR和MET降解，从而阻扰其信号传递；它亦可通过免疫效应细胞，靶向杀伤肿瘤细胞。如此高效的作用机制，造就了埃万妥单抗优异的治疗效果——NCCN指南关于埃万妥单抗的用药推荐：1类推荐——联合卡铂和培美曲塞，一线治疗EGFR exon20ins晚期的NSCLC（非鳞癌）患者；1类推荐——联合拉泽替尼（lazertinib），一线治疗携带EGFR exon19del/L858R的NSCLC患者；1类推荐——联合化疗，后续治疗经奥希替尼治疗进展、携带EGFR exon19del/L858R的晚期NSCLC患者；2A类推荐——后续治疗经铂类化疗进展、携带EGFR exon20ins的NSCLC患者。自从2021年FDA首次批准上市后，埃万妥单抗一路高歌猛进，从单药到组合，从一线到后线，从罕见靶点（EGFR exon20ins）到常见靶点（EGFR 19del/L858R），每一项研究都蕴藏着“敢教日月换新天”的期许和能量。伴随诊断——“优等生”的晋级之路在创新药物全球商业化的进程中，每项新适应症的获批，都会增加广泛的适用人群；而每治疗一名患者，便肩负了一份承诺，一份责任。强生作为全球药企，对药物/诊断的协同布局可谓追求到了极致：纵观埃万妥单抗的成长过程，在全球主要的区域市场，强生都为其搭建了药物与CDx产品的生态系统，以应对各国独特的法规要求，采用最高的标准来确认适用的患者人群，从而确保治疗获益的稳定输出。在美国、日本、中国，埃万妥单抗为了有效定位患者，采用了两种最有效的技术路径：收集肿瘤组织（FFPE）和血浆（plasma）样本，使用在本国获批上市的伴随诊断试剂盒进行分子检测，获得EGFR基因的exon20ins突变结果，从而确认患者是否可以接受治疗。因此，强生在每个国家的市场，通过合作开发的方式，分别布局了“组织+血浆”至少两款CDx产品。尤其是在日本，由于实行的是药物-诊断-医保强绑定的临床应用模式，强生也为药物补充了区域性诊断策略：对于联用EGFR-TKI的适应症，需要识别EGFR常见突变（exon19del和L858R），强生选择了在日本NSCLC临床市占率颇高的产品——艾德生物的人类肺癌11基因（PCR）试剂盒（AmoyDx® Pan Lung Cancer PCR Panel）合作申报伴随诊断[1]，可谓将诊断合规做到极致。伴随诊断——创新药生态的重要一环对于CDx的系统性布局，强生并不是独家：各家跨国药企，为创新抗肿瘤药物，都搭建了完整的生态；专注于生物标志物的高水准诊断产品，正是创新药物生态搭建的支柱。与原研CDx的协同开发，是靶向机制药物上市的必备条件，也是嵌入创新药生命周期的“护身锦囊”。在机遇与风险并存、规则与认知震荡上升的当下，坚守科学本质的“笨办法”，往往才是唯一的捷径。以血浆检测为例，我们穷举在美国获批上市的伴随诊断（液体活检）产品清单，不难看出，肺癌、肠癌、乳腺癌、前列腺癌这些瘤种，已经有成熟的血浆检测临床共识，血浆CDx是药物上市的必选项；而跨国药企的畅销药物，大多都承载了血浆CDx的开发使命。这些创新的CDx产品，开发难度大，而一旦成功上市，却能有效地拓宽适用人群，是药物大规模推广的公认前提。FDA批准的血浆伴随诊断一览（更新至2025年4月）中国伴随诊断，生态正在成长自从2018年，NMPA开始按照“伴随诊断（CDx）”的标准，审批靶向药物相关的IVD产品以来，药物开发者、诊断开发者们，便与监管部门一道展开了执着的探索。尤其是创新药，与CDx的协同开发、共同上市，是产品合规应用的必备保障，也是临床循证的必经之路。过去几年，中国的原研CDx产品的数量已经有了可喜的积累，然而药物/诊断的获批节奏普遍难以同步：上市时间相差一年已经算是乐观情况；更有甚者，药物上市前承诺过的原研CDx计划，挣扎多年无法落实、苦苦找人接盘的也大有人在，此中过程不可谓不艰苦。创新药与CDx的上市时间差，导致标准诊断方法的可及性困难——这使得患者接受的治疗决策，经常暴露在丛林般的信息来源中；而对于靶向驱动的抗肿瘤治疗来说，CDx的缺失，给临床应用蒙上了一层难以预测的合规风险。道虽远，行则将至回到开篇，一款创新药、两款原研伴随诊断、三个月内在国内相继上市——这个协同节奏之紧凑，令人眼前一亮。一家国际顶级药企，一个伴随诊断龙头，强生与艾德交出的这份答卷，实乃在中国药监体系的监督与激励下，药械合作的一次优秀示范。艾德生物的这款NGS试剂盒，适用于两个适应症（肺癌和结直肠癌）的10个临床决策基因：EGFR、ALK、ROS1、RET、KRAS、NRAS、PIK3CA、BRAF、HER2和MET。随着“肿瘤组织+血浆”EGFR exon20ins伴随诊断标签的入列，这款产品将继续作为中国肿瘤CDx的前哨，探索药物与器械协同上市、临床获益模式的新边界。我们也能看到，未来会有更多如强生一样的企业：作为敬畏科学、敢于突破的实践者，加码中国创新药生态的先行者，选择志向相投的合作者，搭建出属于自己的行业丰碑。Copyright © 2025 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

上市批准诊断试剂

2025-05-27

·晨泰医药

中国首发，指南推荐，佐利替尼凭100%入脑能力破解肺癌脑转移治疗难题

肺癌是全球最常见的恶性肿瘤，2022年，全球新发肺癌患者达157万例[1]；中国新发患者高达106万，死亡患者达73万[2]，疾病负担沉重，亟待干预。非小细胞肺癌（NSCLC）是所有肺癌中最常见的，约占85%。其中表皮生长因子受体（EGFR）激活突变是20%~40%NSCLC患者的已知致癌驱动因素。70%的EGFR突变型NSCLC患者会发生脑转移[4]。脑转移严重影响患者预后，其生存期显著低于无脑转移的患者。酪氨酸激酶抑制剂（TKI）是此类患者治疗的常用药物，但患者长期获益仍有待进一步改善。近期在肺癌脑转移领域有突破机制的新药问世，同时获得了国内权威指南的一致推荐，给患者带来全新希望。脑转移高发，超半数突变患者难逃“脑转魔咒”EGFR是一种酪氨酸激酶受体，突变后可导致细胞异常增殖和肿瘤。脑转移是NSCLC患者的常见转移部位之一，EGFR突变的NSCLC患者的脑转移发生率（70%）大大超过了EGFR野生型NSCLC患者（38%）。约25%的EGFR突变阳性NSCLC患者在初诊时就伴有脑转移[5]，超过三分之一的EGFR突变NSCLC患者在病程中会出现中枢神经系统（CNS）进展[4]。以上数据提示，超过半数EGFR突变肺癌患者难逃“脑转魔咒”。EGFR-TKI是EGFR突变阳性NSCLC患者常用的肺癌脑转移治疗药物，但传统EGFR-TKI在治疗肺癌脑转移时往往面临耐药问题。如第一代EGFR-TKI因血脑屏障穿透能力有限，颅内药物浓度不足，导致颅内外病灶控制失衡，使得颅内肿瘤进展成为治疗失败的主要原因。此外，继发EGFR突变、旁路激活、表型转化、肿瘤微环境（TME）介导的耐药等，都可能是传统EGFR-TKI患者生存获益有限的原因。权威指南定调：佐利替尼跻身优先推荐面对传统EGFR-TKI未能满足的临床需求，2024年11月获批的新一代EGFR-TKI佐利替尼以“超速度”赢得中国权威指南的连续认可，为肺癌脑转移患者带来全新的治疗希望：2024年12月，获《中国驱动基因阳性NSCLC脑转移临床诊疗指南（2025版）》[6]推荐：对于EGFR经典突变的NSCLC脑转移初始靶向治疗，佐利替尼（2A）为优选方案之一。2025年3月，佐利替尼正式商业化。2025年4月，中国抗癌学会（CACA）发布的《中国恶性肿瘤学科发展报告（2024）》[8]明确：目前佐利替尼是首个专门为CNS转移患者设计开发的EGFR-TKI，也是唯一非外排蛋白底物的新一代TKI，可100%透过血脑屏障，对NSCLC颅内病灶控制具有独特优势，为CNS转移人群提供了更优的治疗选择。2025年4月，商业化仅一个月，获《中国临床肿瘤学会（CSCO）原发性非小细胞肺癌诊疗指南（2025版）》[7]推荐：新增“佐利替尼”作为EGFR敏感突变伴脑转移Ⅰ级推荐（图1）。（图1）血脑屏障穿透率100%，改写脑转移治疗标准众所周知，指南更新依赖的是扎实的循证医学证据，之所以，佐利替尼在较短时间内屡获推荐正是基于其Ⅲ期随机、对照EVEREST研究（NCT03653546）[9]，该研究纳入439例初诊伴CNS转移的EGFR突变NSCLC患者。结果显示，在超过50%患者为L858R突变或颅内病灶数＞3个、超过60%患者存在颅内靶病灶（颅内靶病灶长径之和更是达到了128 mm）和100%患者既往均未接受过颅内放疗的情况下（表 1），盲态独立中心评估（BICR）根据评估的佐利替尼组颅内无进展生存期（PFS）较对照组延长7个月，颅内进展/死亡风险下降53%（图 2）；研究者评估的佐利替尼组颅内无进展生存期（iPFS）更是达到18个月（图 3）。且预后不良L858R突变和高颅内肿瘤负荷（颅内病灶数＞3个）患者也获益显著，颅内进展/死亡风险分别下降60%和55%（表 2）。佐利替尼主要的耐药机制是T790M突变，后续第三代EGFR-TKI治疗可进一步延长患者总生存期（OS）至37.3个月，数值上超过了奥希替尼一线治疗脑转移患者的真实世界 OS 数据（19.4-31.9个月)[10-15]，达到了奥希替尼FLAURA研究中总人群（80%患者无脑转移）的OS(38.6个月)水平。安全性方面，佐利替尼副作用可预期、可管控，安全谱与既往EGFR-TKI一致，常见为皮疹、腹泻、肝功能异常等，无新增安全信号，无间质性肺病和心肌病发生。从循证证据回望佐利替尼的药代动力学优势，其通过独特的理化特性和非血脑屏障外排蛋白底物设计，实现100%血脑屏障穿透力，并维持颅内高浓度[6]，以上机制学优势和循证医学证据，应是佐利替尼早期和持续获得推荐的原因。（表 1 EVEREST研究中部分重要基线特征）（表 2 L858R突变和颅内病灶数＞3个患者的PFS和颅内PFS获益情况）（图 2 BICR基于mRECIST1.1评估的颅内PFS）（图 3研究者基于RANO-BM评估的评估颅内PFS）以临床需求驱动，让更多患者获益佐利替尼作为新一代EGFR-TKI，其获批上市及纳入临床治疗指南具有重要意义。这意味着对于EGFR敏感突变型非小细胞肺癌（NSCLC）伴中枢神经系统（CNS）转移患者，有了全新的治疗方案。值得注意的是，在提升临床疗效的同时，药物可及性及减轻患者负担仍是当前面临的重要课题。在此背景下，由衢州市医疗健康与社区发展基金会主导、晨泰医药支持的"首望相助·佐佑生命"医疗援助项目正式启动。该项目旨在帮助符合条件的患者持续接受盐酸佐利替尼片（商品名：泽瑞尼®）的规范治疗，缓解经济压力，延长生存期，改善生活质量。晨泰医药首席执行官张勇表示，“晨泰医药始终秉承‘开发临床急需的创新治疗药物’的宗旨，正如佐利替尼的上市填补了肺癌脑转移患者未被满足的临床空白，这也标志着肺癌脑转移治疗已迈入了精准时代。我们期待随着药物可及性的提高，可以为更多患者带来更长久的生存获益，为建设健康中国贡献力量。”关于晨泰医药晨泰医药专注于创新药物从临床研发到商业化运作成功。2024年11月20日，国家药品监督管理局（NMPA）官方网站公示，国家药监局批准晨泰医药申报的1类创新药盐酸佐利替尼片（商品名：泽瑞尼®）上市。本品用于具有表皮生长因子受体（EGFR）19号外显子缺失或外显子21（L858R）置换突变，并伴中枢神经系统（CNS）转移的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗，是全球首个获批的专门针对肺癌脑转移的新一代EGFR-TKI。参考文献1.Filho AM, Laversanne M, Ferlay J, et al. The GLOBOCAN 2022 cancer estimates: Data sources, methods, and a snapshot of the cancer burden worldwide. Int J Cancer. 2025 Apr 1;156(7):1336-1346.2.Zheng RS, Chen R, Han BF, et al. [Cancer incidence and mortality in China, 2022]. Zhonghua Zhong Liu Za Zhi. 2024 Mar 23;46(3):221-231. 3.Gridelli C, Rossi A, Carbone DP, et al. Non-small-cell lung cancer. Nat Rev Dis Primers. 2015 May 21;1:15009.4.Kelly WJ, Shah NJ, Subramaniam DS. Management of Brain Metastases in Epidermal Growth Factor Receptor Mutant Non-Small-Cell Lung Cancer. Front Oncol. 2018 Jul 3;8:208. 5.Preusser M, Winkler F, Valiente M, et al. Recent advances in the biology and treatment of brain metastases of non-small cell lung cancer: summary of a multidisciplinary roundtable discussion. ESMO Open. 2018 Jan 26;3(1):e000262. 6.中国医药教育协会肺癌医学教育专业委员会,北京医学奖励基金会肺癌医学青年专家委员会脑转移协作组. 中国驱动基因阳性NSCLC脑转移临床诊疗指南（2025版）. 中国肺癌杂志, 2025, 28(1): 1-21.7.中国临床肿瘤学会（CSCO）非小细胞肺癌诊疗指南2025.8.中国抗癌学会（CACA）发布的《中国恶性肿瘤学科发展报告（2024）》9.Zhou Q, Yu Y, Xing L, et al. First-line zorifertinib for EGFR-mutant non-small cell lung cancer with central nervous system metastases: The phase 3 EVEREST trial. Med. 2025 Jan 10;6(1):100513. 10.Saw SPL, Low YF, Lai GGY, et al. Real-world outcomes of pemetrexed-platinum chemotherapy plus osimertinib after progression on first-line osimertinib in advanced EGFR-mutated NSCLC. Lung Cancer. 2024 Jul;193:107856. 11.Tatineni V, O'Shea PJ, Ozair A, et al. First- versus Third-Generation EGFR Tyrosine Kinase Inhibitors in EGFR-Mutated Non-Small Cell Lung Cancer Patients with Brain Metastases. Cancers (Basel). 2023 Apr 20;15(8):2382. 12.宁婷婷, 胡钦勇, 李倩, 等. 奥希替尼与埃克替尼一线治疗EGFR阳性转移性NSCLC临床疗效观察. 国际肿瘤学杂志, 2023, 50(2) : 65-70.13.Zhao Y, Li S, Yang X, et al. Overall survival benefit of osimertinib and clinical value of upfront cranial local therapy in untreated EGFR-mutant nonsmall cell lung cancer with brain metastasis. Int J Cancer. 2022 Apr 15;150(8):1318-1328. 14.Niu L, Wu H, Gao R, et al. Optimal sequence of LT for symptomatic BM in EGFR-mutant NSCLC: a comparative study of first-line EGFR-TKIs with/without upfront LT. J Cancer Res Clin Oncol. 2024 Feb 19;150(2):94. 15.Tozuka T, Noro R, Mizutani H, et al. Osimertinib plus local treatment for brain metastases versus osimertinib alone in patients with EGFR-Mutant Non-Small Cell Lung Cancer. Lung Cancer. 2024 May;191:107540.来源：肿瘤资讯

100 项与甲磺酸奥希替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10766	甲磺酸奥希替尼	L01XE	DB09330

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
非小细胞肺癌	加拿大	AstraZeneca Canada, Inc.	2016-07-05
EGFR阳性非小细胞肺癌	日本	阿斯利康制药有限公司	2016-03-28
EGFR 外显子 19 缺失突变型非小细胞肺癌	欧盟	AstraZeneca AB	2016-02-01
EGFR 外显子 19 缺失突变型非小细胞肺癌	冰岛	AstraZeneca AB	2016-02-01
EGFR 外显子 19 缺失突变型非小细胞肺癌	列支敦士登	AstraZeneca AB	2016-02-01
EGFR 外显子 19 缺失突变型非小细胞肺癌	挪威	AstraZeneca AB	2016-02-01
EGFR外显子21替代突变非小细胞肺癌	欧盟	AstraZeneca AB	2016-02-01
EGFR外显子21替代突变非小细胞肺癌	冰岛	AstraZeneca AB	2016-02-01
EGFR外显子21替代突变非小细胞肺癌	列支敦士登	AstraZeneca AB	2016-02-01
EGFR外显子21替代突变非小细胞肺癌	挪威	AstraZeneca AB	2016-02-01
EGFR突变的非小细胞肺癌	欧盟	AstraZeneca AB	2016-02-01
EGFR突变的非小细胞肺癌	冰岛	AstraZeneca AB	2016-02-01
EGFR突变的非小细胞肺癌	列支敦士登	AstraZeneca AB	2016-02-01
EGFR突变的非小细胞肺癌	挪威	AstraZeneca AB	2016-02-01
转移性非小细胞肺癌	欧盟	AstraZeneca AB	2016-02-01
转移性非小细胞肺癌	冰岛	AstraZeneca AB	2016-02-01
转移性非小细胞肺癌	列支敦士登	AstraZeneca AB	2016-02-01
转移性非小细胞肺癌	挪威	AstraZeneca AB	2016-02-01
EGFR-T790M 突变非小细胞肺癌	美国	AstraZeneca Pharmaceuticals LP	2015-11-13

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肿瘤	临床3期	美国	AstraZeneca PLC	2023-05-08
肿瘤	临床3期	中国	AstraZeneca PLC	2023-05-08
肿瘤	临床3期	法国	AstraZeneca PLC	2023-05-08
肿瘤	临床3期	马来西亚	AstraZeneca PLC	2023-05-08
肿瘤	临床3期	波兰	AstraZeneca PLC	2023-05-08
肿瘤	临床3期	中国台湾	AstraZeneca PLC	2023-05-08
肿瘤	临床3期	英国	AstraZeneca PLC	2023-05-08
恶性上皮肿瘤	临床3期	美国	AstraZeneca PLC	2022-08-03
恶性上皮肿瘤	临床3期	中国	AstraZeneca PLC	2022-08-03
恶性上皮肿瘤	临床3期	日本	AstraZeneca PLC	2022-08-03

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临床结果

适应症

分期

评价

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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


Pubmed \| Lung Cancer	N/A	EGFR突变胶质母细胞瘤 EGFR mutations	-	osimertinib (Biopsy specimens)	醖蓋膚鬱築遞選夢衊齋(膚壓壓夢遞憲窪襯餘餘) = 糧簾選簾鬱簾艱餘製壓鏇餘鑰齋齋齋窪膚願積 (夢獵簾製遞積衊衊積鬱 ) 更多	-	2025-06-01
				osimertinib (Resection specimens)	醖蓋膚鬱築遞選夢衊齋(膚壓壓夢遞憲窪襯餘餘) = 糧膚淵糧齋鹽廠鹽夢獵鏇餘鑰齋齋齋窪膚願積 (夢獵簾製遞積衊衊積鬱 ) 更多
Pubmed 人工标引	N/A	EGFR突变的非小细胞肺癌一线 EGFR Mutation \| TP53 Mutation	1,323	Osimertinib (ECOG score ≥2)	蓋艱遞艱齋簾衊遞製襯(餘糧膚觸遞鬱艱齋餘遞) = 鹹積簾獵製遞膚憲鑰築廠鏇積製齋鹽壓壓蓋鹹 (積憲鹽鬱齋鹽顧壓遞襯 )	不佳	2025-05-02
				Osimertinib (Brain metastases)	蓋艱遞艱齋簾衊遞製襯(餘糧膚觸遞鬱艱齋餘遞) = 網築憲窪鹹壓鑰構壓觸廠鏇積製齋鹽壓壓蓋鹹 (積憲鹽鬱齋鹽顧壓遞襯 )
NCT03778229 (SAVANNAH, AACR2025)	临床2期	非小细胞肺癌 EGFRm \| MET	344	Savolitinib 300 mg QD + Osimertinib 80 mg QD	憲齋願繭壓餘構獵糧齋(衊顧選衊鏇醖鹽鹹膚簾) = 網鬱蓋襯鹹襯壓鹹範壓遞願窪膚構鹹顧衊製鹹 (餘鬱餘顧選鹽餘願糧蓋 ) 更多	积极	2025-04-30
OSTAR (AACR2025)	临床2期	非小细胞肺癌Ⅰ期辅助 EGFR-sensitive mutation \| TP53 \| EGFR-other mutations ... 更多	70	Osimertinib 80mg qd	餘糧鹽鑰獵顧衊夢淵繭(夢糧衊廠糧願製糧壓遞) = 鹹網鬱選遞願憲窪願鏇餘餘醖選選廠廠醖齋顧 (獵廠蓋齋壓淵膚遞衊衊 )	积极	2025-04-29
NCT02296125 (FLAURA, AACR2025)	临床3期	一线 EGFRm	127	Osimertinib 80 mg once daily	範觸壓顧蓋網願鑰膚選(糧顧鹽獵壓觸鬱醖網顧) = 築衊齋齋夢範鹹願衊積廠簾壓繭製膚夢醖簾憲 (廠艱鏇範鹽願淵蓋齋願 ) 更多	积极	2025-04-28
				Comparator EGFR-TKI (gefitinib or erlotinib)	範觸壓顧蓋網願鑰膚選(糧顧鹽獵壓觸鬱醖網顧) = 鏇鏇夢醖鹽壓夢襯餘簾廠簾壓繭製膚夢醖簾憲 (廠艱鏇範鹽願淵蓋齋願 ) 更多
NCT04029350 (Pubmed \| BMC Med)	临床2期	EGFR-T790M 突变非小细胞肺癌二线 EGFR T790M mutation	31	Osimertinib + Anlotinib	艱廠簾顧鏇鹹蓋獵範願(構製憲齋鬱廠蓋衊獵廠) = no grade 4 or higher adverse events observed 齋選襯築鏇艱積積顧餘 (糧積範獵選窪窪艱餘窪 )	积极	2025-04-15
NCT03778229 (SAVANNAH, ESMO_ELCC2025) 人工标引	临床2期	EGFR阳性非小细胞肺癌二线 MET Overexpression \| MET Amplification \| EGFR Mutation	101	Savolitinib 300 mg BID + Osimertinib 80 mg QD	餘蓋鹹齋遞繭廠製鑰願(窪襯齋築醖鏇觸鑰憲範) = 醖蓋鹽糧網繭壓蓋製鹹繭簾築範構壓鹹醖襯築 (膚鏇衊鹽窪憲築鏇鬱簾, 45 ~ 67) 更多	积极	2025-03-26
OSIREAL study (ESMO_ELCC2025)	N/A	非小细胞肺癌一线 EGFR mutations	326	Osimertinib monotherapy	糧鑰廠獵餘餘廠願願遞(窪觸醖遞製鬱積積觸蓋) = 廠艱夢窪製鹹鏇艱糧網顧鑰齋選遞網鑰選製艱 (繭構憲構糧網餘網願觸, 13.9 ~ 18.5)	积极	2025-03-26
NCT03521154 (LAURA study, ESMO_ELCC2025)	临床3期	非小细胞肺癌IIIB期 \| 非小细胞肺癌 III期 \| 不可切除的非小细胞肺癌 ... EGFRm 更多	-	Osimertinib	鬱製淵鬱壓廠齋築淵顧(構範築願齋遞襯鏇鏇網): HR = 0.16 (95% CI, 0.1 ~ 0.24), P-Value = < 0.001	积极	2025-03-26
				Placebo
NCT04035486 (FLAURA2, ESMO_ELCC2025)	临床3期	维持 Ex19del/L858R	279	Osimertinib + Platinum-Pemetrexed	範鏇繭築鹽鹹憲壓範簾(憲襯淵繭膚製範築鑰選) = 夢艱廠憲蓋築願觸觸醖選顧築構壓觸繭蓋繭鹽 (糧襯築鏇簾構觸繭膚蓋, 19.6 ~ NC) 更多	积极	2025-03-26
				Osimertinib	衊鏇築築簾鹹築觸獵鏇(積蓋網築衊廠糧鏇繭齋) = 築構蓋淵憲鬱願壓夢鹹鏇膚網餘憲憲齋範觸醖 (憲蓋簾簾糧夢糧選顧艱 )