Phase I/II Study of Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)

Background:
Lung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Surgery to remove the tumors is the standard treatment for people diagnosed with early stages of NSCLC. Despite complete removal of these tumors, many recur (happen again). An FDA-approved drug combination to treat early-stage NSCLC prior to the surgery is durvalumab plus standard chemotherapy. The FDA approved infusion drug azacytidine [AZA] is used to treat several diseases because it can rapidly kill dividing cells (including cancer cells) but it is not approved for NSCLC. An inhaled (aerosolized) form of AZA is also not approved for NSCLC. However, researchers want to know if an inhaled version of AZA can help improve treatment of people with NSCLC because inhaled AZA goes directly into the lungs with limited absorption into the bloodstream.
Objective:
To find the safest and most effective dose of inhaled AZA in participants with early-stage non-small cell lung cancer (NSCLC) that can still be removed by surgery.
Eligibility:
Adults aged 18 and older with operable early-stage NSCLC. Participants will be required to also enroll in NIH protocol 06C0014 which allows for pre- and post-treatment biopsies and bloodwork to be obtained for additional research studies.
Design:
Participants will be screened. They will have a physical exam with blood tests. Their medical records will be reviewed. They will have imaging scans and tests of their heart and lung functions. Participants will be required to have a tissue sample (biopsy) taken of their tumor prior to receiving study drug and again during surgery after Cycle 3; airway tissue biopsies and collection of collect bronchial (lung) fluid may also be done.
Participants will receive the study treatment for 3 cycles. Each cycle is 21 days. They will need to come to the NIH Clinical Center (CC) on days 1-4 of Cycles 1-3.
AZA will be given as a drug mist that can be inhaled (like the type of mist in an asthma inhaler) using a nebulizer at the NIH Clinical Center (CC) for 3 days in a row (consecutive days) during the first week of each cycle. The participant will inhale the AZA drug mist for 20 to 30 minutes each time. Participants will also receive durvalumab and a specific 2-drug assigned chemotherapy by intravenous (IV) infusion on day 4 of each cycle.
Participants will have a follow-up visit 2 weeks after their last dose of study drugs. Then they will have planned surgery to remove the tumors.
Participants will have additional follow-up visits at the NIH CC about 1 and 3 months after the surgery, and then for every 3 months for up to 3 years.
...

开始日期2025-06-17

申办/合作机构

National Cancer Institute

NCT06630325

/ Not yet recruiting临床2期IIT

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART): Adaptive Clinical Treatment (ACT)

This phase II trial tests the how well a precision medicine approach (serial measurements of molecular and architectural response to therapy [SMMART])-adaptive clinical treatment [ACT]) works in treating patients with sarcoma, prostate, breast, ovarian or pancreatic cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). SMMART testing uses genetic and protein tests to learn how cancer changes and to understand what drugs may work against a person's cancer or why drugs stop working. These test results are reviewed by a group of physicians and scientists during a SMMART tumor board who then recommend precision therapy.

开始日期2025-06-16

申办/合作机构

OHSU Knight Cancer Institute

[+3]

NCT06783647

/ Not yet recruiting临床2期

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 01(NSCLC)]

An open-label, multicenter, phase II clinical study to evaluate the efficacy and safety of LBL-024 in combination with other drugs for the treatment of patients with advanced solid tumour.

开始日期2025-06-10

申办/合作机构

南京维立志博生物科技股份有限公司

[+3]

100 项与培美曲塞二钠相关的临床结果

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100 项与培美曲塞二钠相关的转化医学

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100 项与培美曲塞二钠相关的专利（医药）

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4,259

项与培美曲塞二钠相关的文献（医药）

2025-12-01·IMMUNOLOGIC RESEARCH

Assessment of antipsoriatic potential of novel pemetrexed disodium–loaded transdermal patches in an imiquimod-induced mouse model

Article

作者: Yadav, Tejpal ; Gilhotra, Ritu ; Yadav, Hemant Kumar Singh

Psoriasis is a chronic autoimmune skin disorder characterized by keratinocyte hyperproliferation, inflammation, and angiogenesis, significantly impacting patients' quality of life. Current therapeutic strategies, including topical corticosteroids, phototherapy, and systemic biologics, often present limitations such as adverse effects, high costs, and inadequate skin penetration. Transdermal drug delivery offers a promising alternative by enhancing localized drug bioavailability and minimizing systemic side effects. In this study, we investigated the antipsoriatic potential of pemetrexed disodium, a multitargeted antifolate agent, formulated as a transdermal patch in an imiquimod-induced psoriasis mouse model. The patches were prepared using a solvent evaporation technique and optimized for controlled drug release. Mice treated with pemetrexed-loaded transdermal patches exhibited significant dose-dependent reductions in psoriasis severity, as evidenced by improvements in Psoriasis Area and Severity Index (PASI) scores, histopathological analysis, and suppression of inflammatory cytokines (TNF-α, IL-6) assessed via qRT-PCR and ELISA. The highest concentration (0.16 mg/cm²) demonstrated the most pronounced therapeutic effects, comparable to the standard ketoconazole treatment. These findings highlight the potential of pemetrexed disodium-loaded transdermal patches as an innovative, targeted therapy for psoriasis, warranting further clinical investigations.

2025-08-01·INTERNATIONAL DENTAL JOURNAL

Assessment of Novel Boron-doped Mesoporous Bioactive Glass Nanoparticles Loaded Alginate Hydrogel in Dogs

Article

作者: Naga, Marwa Samir ; Ghareeb, Ahmed Zaki ; Kamoun, Elbadawy Abdel Aziz ; El Din, Mona Mohy ; Omar, Samia Soliman Abdel Rehim ; Moaty, Maha Abdel

INTRODUCTION:

Dentin regeneration is pivotal to preserve tooth vitality. This study aims to evaluate, histologically, the dentine regenerative potential of a novel injectable boron-doped, mesoporous, bioactive glass nanoparticle (BMBGNPs) loaded alginate hydrogel in dogs METHODS: The formulation and optimisation of the novel alginate/BMBG NPs (20 wt. %) loaded composite hydrogel were performed. Next, 66 teeth of 3 dogs were allocated into 3 groups (each including 22 teeth) according to post-operative follow-up period: group I: 2 weeks, group II: 4 weeks, and group III: 8 weeks. Each group was further subdivided according to pulpotomy filling material into two subgroups, with subgroup 1 (alginate/BMBGNPs (20 wt. %) loaded hydrogel) and subgroup 2 mineral trioxide aggregate (MTA). Pulp chambers were mechanically exposed through class V cavities. A complete pulpotomy was executed. The tested materials were positioned on the radicular pulp and finally covered with resin composite restorations. One dog was sacrificed after 2, 4, and 8 weeks. Teeth were prepared for histological evaluation assessing inflammatory cell response, pulp tissue organisation, and dentin bridge formation. The Mann-Whitney U test was employed to evaluate the scores of histological parameters between tested materials (P ≤ .05).

RESULTS:

Alginate/BMBG NPs (20 wt. %) loaded hydrogel showed normal pulp configuration at 2 and 4 weeks, which was enhanced after 8 weeks (P ≤ .05). Moderate inflammatory reaction was noted at 2 weeks, which was improved after 4 and 8 weeks (P ≤ .05). MTA group demonstrated less favourable pulpal response and inflammatory reaction with a statistically significant difference across all observational periods (P ≤ .05). After 8 weeks all teeth in group 1 exhibited the thickest dentin bridge (P ≤ .05).

CONCLUSIONS:

Alginate/BMBG NPs (20 wt. %) loaded hydrogel offers the promise of regenerating dentin and maintaining pulp vitality reaching the desired level as an alternative to MTA.

CLINICAL RELEVANCE:

Alginate/BMBG NP loaded hydrogel is an alternative, reliable option for vital pulp therapy.

2025-08-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Simultaneous analysis of various anticancer drugs by supercritical fluid chromatography-mass spectrometry. Part I: Optimization of chromatographic separation

Article

作者: Guillarme, Davy ; Rudaz, Serge ; Fleury-Souverain, Sandrine ; Bonnabry, Pascal ; Nguyen, Nathalie

This work presents a generic SFC-MS method for the simultaneous analysis of 22 anticancer drugs (fluorouracil, busulfan, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, docetaxel, doxorubicin, epirubicin, etoposide, gemcitabine, idarubicin, ifosfamide, irinotecan, methotrexate, paclitaxel, pemetrexed, raltitrexed, topotecan, treosulfan, vinblastine, vincristine). The separation conditions were optimized by screening nine stationary phases (2-picolylamine, bare hybrid silica, 2-ethylpyridine, fluoro-phenyl, octadecyl, diethylamine, diol, 1-aminoanthracene, zwitterionic modification), evaluating additives effects (2-5 % water, 20-50 mM ammonium formate, 0-1 mM ammonium fluoride), and adjusting the organic modifier composition (methanol, ethanol, isopropanol, acetonitrile). The optimized SFC-MS method successfully analyzed 22 anticancer drugs, along with 5 additional challenging compounds (azacitidine, mitomycin, cisplatin, oxaliplatin, carboplatin), in 12 min, using a diol column (100 × 3 mm, 1.7 µm) and a gradient of 2-100 % methanol containing 2 % water and 50 mM ammonium formate. To overcome overpressure generated by high organic solvent content, a backpressure gradient (110-150 bar) and a flow rate gradient (0.6-1.5 mL/min) were applied. The diol column was selected as the most promising based on five predefined chromatographic criteria. Additives with 5 % water or ammonium fluoride were excluded due to overpressure and signal loss, respectively. Increasing ammonium formate concentration improved peak symmetry by 29 %. For the organic modifier, pure methanol was chosen since ternary mixtures led to system overpressure without improving separation. Comparison with the LC-MS method using real samples confirmed the potential applicability of the SFC method, as the same trace compounds were detected with comparable concentrations. Sensitivity optimization and method validation will be discussed separately in a later paper.

1,329

项与培美曲塞二钠相关的新闻（医药）

2025-06-13

·同写意

NSCLC论剑：PD1+VEGF双抗会行吗？

同写意年度巨献！！7月25-26日，邀您相聚金鸡湖畔，与5000人一起为中国医药创新“同写意”！康方摸着石头过河，别人摸着康方过河。康方生物凭一己之力，先是在去年带火了newco的商业模式，又在今年催化了PD1-VEGF双抗出海高潮，礼新生物、三生制药和bioNtech的首付款一浪高过一浪。其实，鉴于之前IO组合死在临床阶段的项目已经横尸遍野，大药企对下一代IO早始终有防备之心。但AK112（依沃西单抗）却凭出色的临床数据，重新点燃了MNC对下一代PD1的热情。• 2024年5月24日，依沃西单抗首次获国家药品监督管理局(NMPA)批准，与化疗(培美曲塞+卡铂)联合，用于EGFR突变且经TKI治疗进展的局部晚期或转移性非鳞状非小细胞肺癌(nsq-NSCLC)。• 2025年4月25日，依沃西单抗再迎里程碑：其新适应症在中国获批，单药用于PD-L1阳性(TPS≥1%)、EGFR/ALK阴性局部晚期或转移性非小细胞肺癌一线治疗。当国内外投资人开始扎堆研究统计学分析AK112数据能否带来ＯＳ优势而不断进行激辩之时，AK112在一年以内先后拿下两个大适应症，有种“两岸猿声啼不住，轻舟已过万重山”的既视感。今年初，在国际肺癌研究协会（IASLC）举办的"肺癌靶向治疗峰会"上，两位胸部肿瘤学权威专家就此议题展开激烈辩论，这两位专家分别是加州大学戴维斯分校综合癌症中心胸肿瘤学主任Jonathan W. Riess教授和密歇根大学医学教授Greg Kalemkerian。知几君不仅对两位的观点进行了点评，后续又深入分析了联合用药与双抗的临床差异化原因，enjoy!TONACEA01正方：PD1+VEGF双抗机制创新，将成为下一代PD1Jonathan W. Riess教授力挺双特异性抗体的崛起，其核心论点聚焦三大优势：1.多靶点协同打击：双抗可同时阻断PD-(L)1等免疫检查点，并干预其他免疫调控环节。Riess首先搬出了IO领域经典的七元循环图，强调双特异性抗体能同时对刺激性和抑制性免疫信号发起攻击，包括阻断免疫检查点、共刺激免疫细胞活化，以及结合细胞因子和炎症因子。作者点评：这不仅仅是给康方站台，也是给所有的IO双抗撑腰，默沙东听完会不会感慨？毕竟他们曾经在PD1-TGFβ深耕多年，最终还是没有赢了K药。2. 独特的机制优势：协同结合效应（cooperative binding）能显著提升疗效。以ivonescimab为例，这种靶向PD-1和VEGF的双抗可使PD-1结合力提升18倍，同时使VEGF结合力增加4倍。作者点评：协同机制说的不够全面，PD1和VEGF联合最大的协同机制在于VEGF可以调节肿瘤微环境，在VEGF存在的情况下，调节性T细胞（T-regulatory cells）会被上调，具有免疫抑制作用。至于互相增强结合力，这个并不是最重要的。3. 早期临床数据亮眼：在临床证据方面，Riess重点提及HARMONi-2 III期研究——该头对头试验显示，在PD-L1阳性NSCLC患者中，ivonescimab相较帕博利珠单抗带来显著的无进展生存期（PFS）获益，且无论PD-L1表达高低均有效。作者点评：PFS数据很好，但是美国FDA不会根据PFS优势批准AK112。TONACEA02反方：PD1+VEGF combo多次折戟，双抗短期难以撼动PD1Greg Kalemkerian则持谨慎态度，他驳斥正方将双特异性抗体视为"全能替代品"的观点，认为双抗短期不会替代PD1，理由如下：1. 现有证据存疑：多项联合治疗研究（涉及超7000患者）均未显示生存获益。2. 失败案例警示：包括LEAP-007（PD1和小分子VEGF联合）以及ARCTIC（双免联合）等关键试验均以失败告终试验均以失败告终。3. HARMONi-2的局限性：虽然ivonescimab数据积极，但缺乏OS数据、随访时间短，且PD-L1 1-49%亚组并非当前标准治疗人群。作者点评：虽然都是基于临床实践的分析，但是确实提出来一个非常有意思的问题，为何PD1和VEGF联用会失败?TONACEA03不同PD1+VEGF双抗的分子设计及作用机制目前已经浮出水面的PD1/L1-VEGF(A)双抗已经有18家，算上潜水的应该会超过30家，与当年的PD1开发热潮十分相似。但与当年PD1的火爆的不同之处在于：很多开发厂家一开始并没有把这个产品当作中心，临床推进速度比较慢。这也使得三生制药这种舍得砸钱的传统药企依靠相对中后期的临床数据赢得了以及普米斯的母公司bioNtech超10亿美元首付款的重磅BD的机会。言归正传，我们还是回归到问题的本质，看看这些双抗的分子结构到底是如何构建的呢？基本上两个路线，一个是免疫检查点端基于PD1和PDL1选择，其中选择PD1的较多，主要有康方、三生、礼新等，这三家均已完成BD合作，选择PDL1的代表性企业是普米斯，也完成了与bioNtech的超级BD交易，后者更是以111亿美金的价格卖给了BMS。主流的PD-(L)1/VEGF(R)双抗都选择了2+2对称结构，相较于非对称结构，对称结构的抗体的生产质量较为可控，但分子量较常规抗体大。其中3款双抗（康方、礼新和普米斯）结构较相似，均以贝伐珠单抗（靶向VEGF-A）为骨架而在重链C端连接PD-(L)1 scFv或VHH。宜明昂科和华海制药的分子结构类似，均在Fab段结合了VEGFR1-D2和PDL1。AK112作用机制图：iScience 28, 111722，2025通个结构来看，只有PD1/L1和VEGF分别分布在Fab和Fc两侧才更可能产生跟康方AK112类似的多聚体形式的亲合力增强效应。但三生SSGJ-707的结构与AK112差别很大，重链C端Fv段结合了贝伐，而Fab段结合了PD-1，也就是PD1和VEGF串联的方式，宜明昂科和华博生物也采用了类似串联的方式。这种结构由于空间位阻效应，很难通过双抗与VEGF二聚体的结合增强PD1的亲和力，没办法画出类似康方的漂亮的机制图。但SSGJ-707并没有因为结构和机制上与AK112的区别而影响活性，甚至优于AK112：SSGJ-707在临床上表现也非常出色，表现出了best in class的前置，这也是吸引辉瑞的原因之一：SSGJ-707单药一线治疗PD-L1表达阳性晚期NSCLC表现出了良好的抗肿瘤活性，10mg/kg Q3W剂量水平ORR达到了67.6%，其中确认的ORR高达64.7%，DCR高达97%。与同类药物依沃西单抗在该适应症疗效相当（依沃西单抗一线治疗PD-L1表达阳性晚期NSCLC，ORR为50%，DCR为89.9%）。PD1+VEGF双抗机制到底是啥？在知几君看来，主要就是PD1协同了VEGF抗体或者VEGF trap阻断VEGF因子的能力，抗血管生成+调节免疫，而互相增强亲和力，并不是主要的，亲和力调节可以通过序列设计优化实现。TONACEA04为何PD1+VEGF组合药物会失败？为何1+1＜1？我们再次回到PD1+VEGF组合在肺癌的失败案例并尝试分析其失败的原因。首先我们LEAP-007，这项临床试验是探索“可乐”组合即pembrolizumab（PD1）＋lenvatinib（小分子VEGF抑制剂）“针对一线 PD-L1 阳性 NSCLC 的 3 期临床试验。该试验共计纳入了623名PDL1表达量＞1%的晚期非小细胞肺癌患者，最后的临床结果显示，pembrolizumab＋lenvatinib联合用药的的中位OS为14.1个月，而pembrolizumab单药组的中位OS为16.4个月，HR=1.10，联合用药不仅没有延长OS，反而降低了OS。但是如果我们看PFS数据，pembrolizumab＋lenvatinib组合是有显著优势的，联合用药组的PFS为6.6个月，pembrolizumab单药组的PFS为4.2个月，HR=0.78，p=0.00624。那到底是什么导致了一开始的PFS优势没能转化为OS优势呢？我们从其安全性数据可以看出显著差异的端倪：PD1+VEGF联合用药组的3级以上AE事件是PD1单药的2倍以上，致死率更是接近3倍，联合用药组有16人死亡，PD1单药组仅有6人死亡。因此我们有理由推测，PD1+VEGF糟糕的安全性问题是导致最终没有实现OS优势的主要原因之一。我们再来看AK112的HARMONi-2的临床数据，有效性数据大家已经非常熟悉了，PFS强阳性数据，HR=0.51。我们重点关注一下安全性数据，AK112总人群的三级以上AE比例为29.4%，而K药单药比例为15.6%，AK112约为K药的2倍。严重SAE事件，AK112组为20.8%，K药组为16.1%，由于AE导致的停药和致死事件都小于K药单药组。总体来讲，AK112双抗组会增加AE事件的发生，3级以上AE是K药的2倍，但是致命的SAE发生比例比K药也高出不少，虽然死亡和停药人数较K药少，但是由于人数太少，很难最终对OS结果产生大幅影响。基于上述分析，我们能看出HARMONi-2 临床中的PD1+VEGF双抗相较于LEAP-007临床中的PD1+VEGF联用安全性有一定的提升，但很难用压倒性优势形容。LEAP-007中联合用药组的OS延长了，而是缩短了，那么AK112能否靠药效和安全性的小优势，转化为最终的OS优势呢？只能说非常有挑战，让我们持续关注HARMONi-2临床试验最终的OS结果吧！— 结语 — 双抗的开发，尤其是新老靶点之间的组合，曾是5年前的网红赛道，PD1/L1可叠加的靶点非常多，ＰD1-VEGF在当年一点都不性感，谁能想到如今成了当红炸子鸡。关于PD1与VEGF的组合，从科学上似乎有着合乎逻辑的解释，但是回归到临床，尤其是肺癌领域，目前也确实没有足够的证据说明OS的优势。新药开发是循证医学，PD1+VEGF双抗的底牌最终将会被揭开，而IO里面的原霸主默沙东也不得不通过BD引入礼新医药的PD-1/VEGF双抗，为自己留条后路。“The vast population of this earth, and indeed nations themselves, may readily be divided into three groups. There are the few who make things happen, the many more who watch things happen, and the overwhelming majority who have no notion of what happens. ”参考资料：1. ILCN：Will Bispecific Antibodies Replace PD-(L)1 Targeted Agents?2. 东吴证券医药生物行业跟踪周报：康方生物PD1/VEGF双抗研发成果，点燃全球双抗热情3. 2022 ASCO：A phase Ib/II study of AK112, a PD-1/VEGF bispecific antibody, as first or second-line therapy for advanced non-small cell lung cancer (NSCLC)AL MEETIN4. Zhong et al., 2025, iScience 28, 1117225. Pembrolizumab With or Without Lenvatinib for First-Line Metastatic NSCLC With Programmed Cell Death-Ligand 1 Tumor Proportion Score of at least 1% (LEAP-007): A Randomized, Double-Blind, Phase 3 Trial，https://doi.org/10.1016/j.jtho.2023.12.0236.康方官网https://akesobio.com/media/2293/wclc-2024-presentation-ak112-303-final.pdf

2025-06-12

·ioncology

2025 ASCO | NeoADAURA 研究结果重磅公布，Jamie E.Chaft 教授权威解读奥希替尼新辅助治疗新突破

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”ASCO 2025 微专辑扫描二维码可查看更多内容2025年美国临床肿瘤学年会（2025 ASCO）于5月30日-6月3日在美国芝加哥举行。作为全球规模最大、学术水平最高且最具权威性的临床肿瘤学盛会，ASCO年会汇聚了全球肿瘤学领域的医生、专业人士、患者倡导者、工业界代表以及主流媒体，共同聚焦国际前沿的研究发现与临床试验成果。本届ASCO大会，来自纪念斯隆凯特琳癌症中心（MSKCC）的Jamie E. Chaf教授公布了NeoADAURA 研究结果，该研究旨在探索新辅助奥希替尼作为单一疗法或联合化疗与单独化疗在可切除的 II-IIIB 期 EGFRm NSCLC 患者中的疗效和安全性。《肿瘤瞭望》特邀Jamie E. Chaf教授现场解读该项研究成果、分享新辅助靶向治疗在肺癌领域探索进展及未来展望。特此整理，以飨读者。研究介绍摘要号：8001Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.新辅助奥希替尼（osi）±化疗（CT）对比单纯 CT 治疗可切除（R）EGFRm NSCLC：NeoADAURA 研究Jamie E. Chaft纪念斯隆凯特琳癌症中心（MSKCC）胸部肿瘤内科医生，专注肺癌治疗，擅长多学科协作制定个性化方案，涵盖手术、放化疗、免疫治疗及靶向治疗。主持开展多项早期非小细胞肺癌（NSCLC）临床策略探索研究，包括新辅助免疫治疗和生物标志物驱动的精准医疗研究。研究背景基于III期ADAURA研究结果，奥希替尼——一款三代EGFR-TKI类药物，获批用于EGFR突变的Ib-IIIa期非小细胞肺癌（NSCLC）患者术后辅助治疗。既往研究表明，新辅助治疗可提高手术切除率并可能改善患者长期预后。NeoADAURA研究是一项全球、III期、随机对照、三臂临床研究，旨在评估新辅助奥希替尼±化疗相较于单纯化疗在EGFR突变阳性NSCLC患者的疗效及安全性。研究方法在这项研究中，患者年龄≥18周岁，PS评分0-1分，患者携带19del或21L858R突变，分期为II-IIIb期（第8版分期）。研究基于分期（II vs. III期）、种族（非亚裔、中国人、其他亚裔）和突变类型（19del vs. 21L858R）进行分层。符合入组标准的患者按1:1:1的比例，随机分为奥希替尼80 mg，口服，每日一次，治疗时间超过9周；联合3周期化疗（顺铂或卡铂联合培美曲塞）或超过9周的标准剂量的奥希替尼治疗，或单纯化疗。所有患者均可以接受术后辅助奥希替尼治疗。主要研究终点为独立评审委员会评估的MPR，次要研究终点包括pCR、EFS及安全性。数据随访截止时间2024年10月15日。研究结果共计358例患者随机分配，奥希替尼联合化疗组、单药奥希替尼组、单纯化疗组分别入组121例，117例和120例患者，基线特点均衡可比。II期患者占比分别为49%、50%和51%；非亚裔患者占比分别为27%、26%和25%；19del患者占比分别为50%、51%和51%。接受新辅助治疗后，分别有92%、97%和89%的患者接受手术治疗。有效性评估中，奥希替尼联合化疗组、单纯奥希替尼组和单纯化疗组的MPR分别为26%、25%和2%；pCR率分别为4%、9%和0%；12个月EFS率分别为93%、95%和83%。EFS中期分析结果（15%成熟度）展示了奥希替尼联合化疗以及单药奥希替尼的获益趋势。三组均有超过80%的患者接受了术后辅助奥希替尼的治疗。安全性评估，在新辅助治疗阶段，奥希替尼联合化疗组、单药奥希替尼组、单纯化疗组，≥3级全因不良反应发生率分别为36%、13%和33%，因不良反应而导致治疗终止的比例分别为9%、3%和5%。30天内无患者出现死亡事件。研究结论新辅助奥希替尼联合或不联合化疗，相较于单纯化疗显著改善了EGFR突变可切除NSCLC患者的MPR。EFS数据并不成熟，但展示了支持含有奥希替尼治疗策略的趋势，没有新的安全性信号出现。对于可手术切除的携带EGFR突变的NSCLC患者，奥希替尼为基础的新辅助治疗策略应当被考虑。肿瘤瞭望首先请您解读下本次大会公布的NeoADAURA研究关键性研究结果及临床意义？Prof.Jamie E. Chaft我很荣幸在今年 ASCO上分享了 Ⅲ 期 NeoADAURA 研究结果，该研究旨在评估在可切除的 EGFR 突变非小细胞肺癌（NSCLC）患者中，术前新辅助使用奥希替尼联合或不联合化疗对比单纯化疗的疗效。该研究纳入了基线时诊断为可切除的Ⅱ–IIIB 期EGFR 突变阳性NSCLC患者，随机平均分配至奥希替尼联合化疗组、单药奥希替尼组、单纯化疗组。主要终点是手术时由盲态独立中心评估的主要病理缓解（MPR）。次要终点包括无事件生存期（EFS）、病理完全缓解（pCR）、安全性和耐受性。通过盲态独立评审，含奥希替尼的两组较单纯化疗组在 MPR 率上均显示出具有统计学意义的显著改善。Q1：Please interpret the key findings and clinical implications of the NeoADAURA study presented at the conference?Prof.Jamie E. Chaft：I was so honored to present the phase Ⅲ NeoADAURA study at ASCO this year, which will evaluate neoadjuvant osimertinib with or without chemotherapy versus chemotherapy alone prior to surgery, in patients with EGFR-mutated resectable non-small-cell lung cancer. The study enrolled patients with stage stage II–IIIB EGFR mutation-positive NSCLC determined to be receptible at baseline, and the randomization was equal between arms. The primary end point was centrally assessed major pathological response (MPR) at the time of surgery. Secondary end points include event-free survival, pathological complete response, nodal downstaging at the time of surgery, disease-free survival, overall survival and health-related quality of life. Safety and tolerability will also be assessed. By blinded independent review, both osimertinib containing arms showed statistically significant improvement in the MPR rate over chemotherapy alone. 肿瘤瞭望数据显示奥希替尼单药组（25%）与联合化疗组（26%）的 MPR 率接近，但联合化疗组的≥3 级不良事件发生率（36%）显著高于单药组（13%）。基于这一数据，您认为在临床实践中“新辅助奥希替尼±化疗”的策略选择需主要考量哪些因素？Prof.Jamie E. Chaft在既往研究及临床实践中，我们普遍认为，两种药物联合使用的毒性会比单一药物更大，在本项研究中亦然，但整体来看，NeoADAURA 研究中的毒性特征与我们从 FLAURA2 研究及其他研究中对该联合方案的认知完全一致，仅有 1 例患者因不良事件导致无法接受手术切除，这个数字实际上相当可喜。该研究并未探讨不同患者选择最优方案的问题，我认为这正是医学的艺术性所在。我们当然知道化疗可以提高可切除NSCLC患者的治愈率，但究竟是术前给予奥希替尼并在术后给予辅助化疗，还是在术前一线治疗中同时给予两者，我们目前尚无答案。我认为在现阶段，我们只能根据患者的病情及体能状态来做出判断。Q2：Data showed that the MPR were comparable between the osimertinib monotherapy group and the combination chemotherapy group, while the incidence of ≥Grade 3 AE in the combination chemotherapy group was significantly higher than that in the monotherapy group. Based on this data, what factors do you believe should be primarily considered in clinical practice when selecting between "neoadjuvant osimertinib±chemotherapy" strategies? Prof.Jamie E. Chaft：So I can say the toxicity was greater in the combination arm that anticipated, right? We would expect toxicity to be more with two drugs versus one. And the profiles were entirely consistent with what we know of the combination from FLAURA2 and other studies. There was only one adverse event that precluded surgical resection. So that's actually a pretty amazing number. So who to choose for which approach is not something that this study addressed.I think that's where the art of medicine comes in. We certainly understand that chemotherapy can improve the cure rate in patients with respectable NSCLC, whether to give osimertinib pre-operatively and chemotherapy adjuvantly or to give both together in the front line setting before surgery is a question we don't have the answer to. I think at this point we just have to use our judgment about the fitness of the patient.肿瘤瞭望现阶段研究成果展现了含奥希替尼的两个治疗组均显示出优于单纯化疗的趋势。结合ADAURA研究中辅助治疗的长期获益数据，您如何看待新辅助奥希替尼对早期 NSCLC患者整体生存获益的潜在影响？Prof.Jamie E. Chaft我认为需要开展一项比我们所进行的研究规模更大的研究，才能证明这种治疗方法具有总生存获益。我们确实观察到了早期的无事件生存优势。然而，这一优势可能会因所有患者在各治疗组中均接受辅助治疗而被稀释，因此，本研究中未将总生存作为预设终点。不过，未来若开展大规模真实世界研究，我确实认为可将生存曲线的早期分离最终将转化为临床获益。Q3：Combining the long-term benefit data from the adjuvant therapy arm in the ADAURA study, how do you view the potential impact of neoadjuvant osimertinib on the overall survival benefit for early-stage NSCLC patients?Prof.Jamie E. Chaft：I think it would take a much larger study than we performed to show an overall survival benefit of this approach. What we do see is an early event, Free survival advantage. However, that will likely be watered down by the adjuvant prescription across arms to all patients. So this study, I would be surprised if it showed an overall survival outcome. It's actually not the planned endpoint of the study. However, if we had a much larger real world study, I do imagine that early separation of the curves is going to ultimately translate into clinical benefit.肿瘤瞭望基于当前结果，您认为未来新辅助靶向治疗在可切除（R）EGFRm NSCLC领域探索方向有哪些？Prof.Jamie E. Chaft不可否认，开展这类研究难度很大，而且该领域仍存在很多争议 —— 哪些患者需要新辅助治疗，以及需要多少新辅助治疗。我承认，尽管无论是否联合化疗，奥希替尼治疗都比单纯化疗效果好得多，但我希望我们能做得更好，希望我们的病理完全缓解率能达到或超过野生型人群中新辅助化疗联合免疫治疗的效果。因此，我希望未来我们能找到真正杀死肿瘤细胞的药物，但目前我们仍在等待这些新型药物及联合治疗方案的出现。Q4:Based on the current results, what do you consider the future research directions for neoadjuvant targeted therapy in resectable (R) EGFR-mutated NSCLC? Prof.Jamie E. Chaft：These studies are admittedly difficult to run, and there remains a lot of debate in the field about who needs neoadjuvant therapy and how much I will admit that while giving osimertinib with or without chemotherapy was much better than chemotherapy alone, I wish we were doing even better and that our pathologic complete response rates were as good or better than those we see with neoadjuvant chemo-IO in wild type populations. So I hope we can find drugs that truly kill the cancer in the future. And but we're still waiting for those novel combinations to exist.肿瘤瞭望ASCO年会作为肿瘤领域首屈一指的盛会，展现了当前国际最前沿的临床肿瘤学科研成果和治疗技术。您作为肺癌领域专家，请您分享下参会感受及关注热点？Prof.Jamie E. Chaft本届ASCO年会我所关注的热点话题包括扩大我们针对其他罕见基因驱动肺癌的口服靶向治疗手段的耐受性。在本届大会中，我们看到了针对EGFR、Her-2 以及 KRAS 靶向治疗的出色数据。此外，我们也看到使用循环肿瘤 DNA（ct-DNA）指导治疗的实际应用，期待未来在这方面有更多进展。Q5:As the premier global conference in oncology, the ASCO Annual Meeting shows the most cutting-edge clinical oncology research achievements and treatment technologies. As an expert in the field of lung cancer, could you share your conference experience and key focuses of interest?Prof.Jamie E. Chaft：I think the hot topics we have moving forward are expanding our arsenal of tolerated, oral targeted therapies for other oncogene driven lung cancers. We saw great data are presented for EGFR and Her-2 targeted therapies as well as KRAS. I also think we're beginning to see the practical implications of using ct-DNA to guide therapy, and I look forward to more of that in the future. （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议临床结果临床3期免疫疗法

2025-06-12

·默沙东中国

默沙东于ASCO公布I期KANDLELIT-001研究数据

默沙东于ASCO公布I期KANDLELIT-001研究数据该下一代CD3/CD19 双特异性抗体对于B细胞恶性肿瘤和自身免疫性疾病具有应用潜力将增强并丰富默沙东的在研管线美国新泽西州罗威市，2025年5月30日——默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号）公布了开放标签I期KANDLELIT-001研究的安全性和疗效结果。该临床试验旨在评估试验性新一代KRAS G12C抑制剂MK-1084单药治疗以及与其他疗法联合治疗特定KRAS G12C突变实体瘤患者的效果，这些实体瘤包括晚期结直肠癌（CRC）和非小细胞肺癌（NSCLC）。KANDLELIT–001研究中关于CRC和NSCLC的数据在2025年美国临床肿瘤学会（ASCO）年会上展示（摘要编号分别为 #3508和 #8605）。Marjorie Green博士默沙东实验室高级副总裁兼肿瘤学全球临床开发负责人“我们期待进一步探索MK-1084作为单药治疗或联合治疗的潜力，包括在某些情况下与帕博利珠单抗联合治疗KRAS突变患者。KRAS突变是癌症中最为常见的突变类型之一。我们致力于评估创新疗法的潜力，以帮助更多癌症患者。这些数据进一步表明了我们强大且具有差异化的研发管线所拥有的潜力。”KANDLELIT-001是一项I期、开放标签、多中心临床试验（ClinicalTrials.gov编号：NCT05067283），旨在评估MK-1084单药治疗以及与其他疗法联合治疗KRAS G12C突变的晚期实体瘤患者的安全性、耐受性、药代动力学和疗效。该试验的主要终点为安全性和耐受性，通过发生剂量限制性毒性、不良事件和治疗中止的患者数量进行评估。次要终点包括客观缓解率（ORR）和缓解持续时间。在结直肠癌（CRC）领域，该研究对MK-1084单药治疗以及其与西妥昔单抗（cetuximab）联合用药（联合或不联合化疗，化疗方案为奥沙利铂、亚叶酸钙联合 5-氟尿嘧啶[mFOLFOX6]）的情况进行了评估。在非小细胞肺癌（NSCLC）方面，对MK-1084单药治疗以及其与帕博利珠单抗联合用药（联合或不联合化疗，化疗方案为卡铂和培美曲塞）的情况进行了评估。除KANDLELIT-001研究外，MK-1084还在III期 KANDLELIT-012研究中进行评估。KANDLELIT-012研究旨在探究MK-1084联合西妥昔单抗和mFOLFOX6用于携带KRAS G12C突变肿瘤的局部晚期不可切除或转移性CRC患者的一线治疗。此外，MK-1084还在III期KANDLELIT-004研究中进行评估。KANDLELIT-004研究旨在探究MK-1084联合帕博利珠单抗用于携带KRAS G12C突变肿瘤且程序性死亡配体1 (PD-L1) 肿瘤比例分数 (TPS) ≥50%的转移性NSCLC患者的一线治疗。MK-1084是在与大鹏药品工业株式会社（Taiho Pharmaceutical Co., Ltd.）以及大冢制药株式会社（Otsuka Pharmaceutical Co., Ltd.）的全资子公司Astex Pharmaceuticals (UK）的合作与许可协议下进行研发的。*截至目前，MK-1084尚未在中国境内获批。若您想了解更多有关疾病知识的信息，请咨询医疗卫生专业人士06-2025-CN-NON-00582关于默沙东在默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号），我们齐心协力追求共同的目标：我们发挥前沿科学的力量，在全球范围内拯救生命、改善生活。130多年来，我们通过研发重要药物和疫苗，为全人类带来希望。我们致力成为顶尖的研究密集型生物制药公司——当下，我们正处于研发前线，推出创新解决方案，以推进人类和动物疾病的预防和治疗。我们建立了一个多元、包容的全球员工体系，以负责的态度经营每一天，确保所有人、所有社区都能有一个安全、可持续和健康的未来。更多信息，请访问www.msd.com，并在X（前身为Twitter）、LinkedIn和Youtube平台关注我们。关于默沙东中国中国是默沙东全球增长战略中至关重要的一部分。默沙东中国总部设在上海，同时在北京设有研发中心、在杭州、宁波和天津分别设有工厂，实现了研发、制造和商业运营三擎合一。我们全心全意，向中国大众提供高质量的创新药物、疫苗和服务，造福中国社会。更多信息，敬请访问默沙东中国官网，或关注默沙东中国在微信上的官方社交媒体账号。默沙东前瞻性声明默沙东是美国新泽西州罗威市默克公司的公司商号（下称“公司”）。本新闻稿包含根据《1995 年美国私人证券诉讼改革法案》之安全条款而做出的“前瞻性声明”。本文内容基于公司管理层当前的看法和预期，并且受制于可能出现的重大风险和不确定因素。默沙东不保证在研产品能获得所需的监管部门批准或取得商业成功。如果相关假设与现实有所出入、出现风险，或发生不确定情况，实际结果可与前瞻性声明中的预期有实质上的差异。风险和不确定因素包括但不仅限于一般行业情况与竞争、一般经济因素（包括利率与汇率浮动）、美国及其他国家制药行业监管以及医疗政策的影响、全球范围内控制医疗成本的趋势、技术发展、竞争对手获得的新产品与专利、新产品开发固有的挑战（包括获得监管部门批准）、默沙东对未来市场形势做出准确预测的能力、生产上的困难或迟延、国际经济金融状况不稳定与主权风险、对默沙东专利和其它创新产品保护的有效性的依赖程度，以及公司面临专利诉讼和/或监管行动的风险。默沙东没有义务就新信息、未来事件或其它原因对任何前瞻性声明进行公开的更新。尚有其它因素可能导致实际结果与前瞻性声明存在实质性差异，请参见默沙东2024年年报10-K报表以及公司在美国证券交易所备案的其它文件（可在美国证券交易所网站www.sec.gov上查阅）。

临床1期ASCO会议临床3期临床结果

100 项与培美曲塞二钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	培美曲塞二钠	L01BA04	DB00642

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
转移性非鳞状非小细胞肺癌	美国	Hospira, Inc.	2022-06-10
不可切除的胸膜恶性间皮瘤	欧盟	Sandoz GmbH	2015-09-18
不可切除的胸膜恶性间皮瘤	冰岛	Sandoz GmbH	2015-09-18
不可切除的胸膜恶性间皮瘤	列支敦士登	Sandoz GmbH	2015-09-18
不可切除的胸膜恶性间皮瘤	挪威	Sandoz GmbH	2015-09-18
非鳞状非小细胞肺癌	美国	Eli Lilly & Co.	2009-07-02
间皮瘤	美国	Eli Lilly & Co.	2004-08-19
非小细胞肺癌	美国	Eli Lilly & Co.	2004-08-19
局部晚期非小细胞肺癌	澳大利亚	Eli Lilly Australia Pty Ltd.	2004-06-30
转移性非小细胞肺癌	澳大利亚	Eli Lilly Australia Pty Ltd.	2004-06-30
恶性胸膜间皮瘤	美国	Eli Lilly & Co.	2004-02-04

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
KRAS G12C突变非小细胞肺癌	临床3期	美国	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	中国	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	日本	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	澳大利亚	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	奥地利	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	比利时	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	巴西	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	加拿大	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	捷克	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	丹麦	Eli Lilly & Co.	2023-12-21

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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


NCT04967417 (PHOEBS, CTgov)	临床2期	非小细胞肺癌 \| 转移性非小细胞肺癌 \| 脑转移瘤	13	Carboplatin+Pembrolizumab+Pemetrexed (Non-squamous Cell Carcinoma)	淵鹹夢淵築製製膚鹽窪(鏇獵遞淵鬱觸衊積廠餘) = 淵遞簾觸繭積鏇蓋範壓顧醖範繭遞構顧觸鹽製 (壓淵獵範夢構獵鹽壓廠, 選積艱餘選齋網築網衊 ~ 選衊鹽範醖艱簾製廠鬱) 更多	-	2025-05-09
				Carboplatin+Paclitaxel+Pembrolizumab (Squamous Cell Carcinoma)	淵鹹夢淵築製製膚鹽窪(鏇獵遞淵鬱觸衊積廠餘) = 選觸遞齋網獵構夢鑰鬱顧醖範繭遞構顧觸鹽製 (壓淵獵範夢構獵鹽壓廠, 艱顧醖鹽壓願選鏇鬱網 ~ 蓋襯構鑰鹹製鑰願壓鬱) 更多
NCT03137771 (NRG-LU002, CTgov)	临床2期	转移性非小细胞肺癌 \| 复发性非小细胞肺癌	218	Erlotinib Hydrochloride+Gemcitabine+Docetaxel+pembrolizumab+Pemetrexed Disodium (Arm 1 (Systemic Maintenance Chemotherapy))	簾築膚觸鹽簾襯餘醖窪(積顧艱範構壓壓顧襯遞) = 鏇簾顧淵窪鏇艱簾淵願獵製憲鹽願觸網廠襯積 (鹽窪範願壓餘齋簾築蓋, 積廠廠積鹽糧簾網壓願 ~ 製範選願鏇夢顧廠範鏇) 更多	-	2025-03-11
				Stereotactic Body Radiation Therapy (SBRT)+Erlotinib Hydrochloride+Gemcitabine+Docetaxel+pembrolizumab+Pemetrexed Disodium (Arm 2 (LCT + Systemic Maintenance Chemotherapy))	簾築膚觸鹽簾襯餘醖窪(積顧艱範構壓壓顧襯遞) = 窪選齋選膚窪餘淵願鑰獵製憲鹽願觸網廠襯積 (鹽窪範願壓餘齋簾築蓋, 鑰糧衊壓鏇構範醖廠鹹 ~ 範願鑰淵選糧獵鹹餘餘) 更多
NCT04158141 (CTgov)	临床3期	恶性胸膜间皮瘤	16	Pleurectomy+Carboplatin+Pemetrexed+Cisplatin+Pemetrexed Disodium (Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment))	齋築襯繭壓鏇鏇鬱築範 = 鹽鑰願夢壓遞窪鹽積遞獵齋齋鏇醖壓選醖顧選 (廠簾範積壓膚鬱夢顧製, 淵網糧膚艱築鹹築鏇鏇 ~ 憲製衊齋鹹膚鹹醖醖衊) 更多	-	2025-02-19
				Intensity-Modulated Radiation Therapy+Carboplatin+Pemetrexed+Cisplatin+Pemetrexed Disodium (Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS))	齋築襯繭壓鏇鏇鬱築範 = 衊築範艱鑰襯襯網蓋鑰獵齋齋鏇醖壓選醖顧選 (廠簾範積壓膚鬱夢顧製, 鏇鑰範鏇蓋夢憲醖選蓋 ~ 鹽鑰築醖齋築衊願鏇衊) 更多
NCT05786430 (LUCAS, ESMO_ASIA2024) 人工标引	临床2期	EGFR突变的非小细胞肺癌 EGFR Mutation	54	Lazertinib + Pemetrexed + Carboplatin	製構膚顧鹽壓網網願餘(窪齋窪製獵窪鹹艱衊廠) = 鏇顧鏇鏇築選築簾築顧淵鏇醖窪壓窪製餘餘網 (鬱壓構鬱淵膚衊願鑰窪, 5.16 ~ 9.56) 更多	积极	2024-12-07
CTRI/2022/08/044939 (ESMO_ASIA2024) 人工标引	临床2期	原发性腹膜癌 \| 卵巢上皮癌	63	Pemetrexed 500 mg/m2	獵網鏇廠簾鬱廠鏇鬱積(襯網蓋衊廠觸獵廠網壓) = 選願壓憲製鏇襯糧構網積範淵築遞夢顧鬱衊淵 (鏇憲糧繭蓋憲膚夢積醖 ) 更多	积极	2024-12-07
NCT01088906 (Phalcis, CTgov)	临床2期	晚期鳞状非小细胞肺癌 \| 非鳞状非小细胞肺癌	57	Pemetrexed+Cisplatin (EXPERIMENTAL ARM)	鬱淵衊艱築簾襯夢窪選 = 齋鬱齋餘築廠製獵觸範網廠鹽範廠餘鹽願艱遞 (觸襯淵淵襯選憲網鑰壓, 廠膚鑰願餘顧積窪製淵 ~ 膚獵蓋衊製繭鹽廠獵範) 更多	-	2024-10-15
				Pemetrexed+Cisplatin (Experimental Arm: Pemetrexed Plus Cisplatin)	築鬱願餘膚糧遞淵製醖(顧鑰糧艱製醖廠繭積鑰) = 窪蓋觸襯願醖鏇鑰衊齋餘餘鏇膚艱積夢範構醖 (餘繭選範壓壓積壓積醖, 壓夢鑰鹽膚築遞獵醖廠 ~ 壓鹽蓋憲獵襯艱醖顧鹽) 更多
NCT05198830 (NCI 10512, ASTRO2024)	临床2期	非小细胞肺癌 III期 UNG expression	-	TRC102 in combination with Pemetrexed-Platinum-Radiation	鏇範齋範繭鏇鹹築蓋顧(鹽積鑰淵鑰糧憲淵鑰齋) = 構醖築願糧獵鬱鏇鏇膚獵廠製艱衊鑰醖遞獵壓 (廠鏇鏇遞鏇製醖憲繭糧 )	积极	2024-10-01
				Cisplatin-Pemetrexed-Thoracic Radiation followed by Durvalumab	鏇範齋範繭鏇鹹築蓋顧(鹽積鑰淵鑰糧憲淵鑰齋) = 願製願膚廠獵窪淵鏇繭獵廠製艱衊鑰醖遞獵壓 (廠鏇鏇遞鏇製醖憲繭糧 )
WCLC2024 人工标引	N/A	恶性胸膜间皮瘤二线 \| 一线	267	Nivolumab pNivolumabmumabIpilimumabpemetrexed	醖鹹構艱糧選廠齋餘艱(網夢夢積願鹹齋繭構鹹) = 製壓齋糧淵獵網廠齋壓壓蓋繭廠網壓製鬱遞醖 (鹹簾齋構蓋蓋簾觸艱鹽, 7.7 ~ 8.5)	积极	2024-09-09
NCT04335292 (OCELOT, WCLC2024) 人工标引	临床2期	EGFR突变肺癌二线 EGFR Mutation	29	Platinum Pemetrexedpemetrexed	窪鏇齋網衊夢築廠簾製(糧餘顧簾觸築襯壓膚衊) = 顧鏇壓膚獵鹹鹽觸構簾構簾壓淵築簾觸襯窪鏇 (獵壓淵簾衊壓淵壓衊壓 ) 更多	积极	2024-09-08
				platinum (carboplatin or cisplatin) + pemetrexed (uncommon EGFR mutations)	窪鏇齋網衊夢築廠簾製(糧餘顧簾觸築襯壓膚衊) = 衊齋鑰顧蓋網蓋鹹顧獵構簾壓淵築簾觸襯窪鏇 (獵壓淵簾衊壓淵壓衊壓 ) 更多
NCT04035486 (FLAURA2, CTgov)	临床3期	EGFR阳性非小细胞肺癌	587	Carboplatin+Pemetrexed+AZD9291 (Safety Run-In: AZD9291 + Carboplatin + Pemetrexed)	衊鹹獵顧鏇蓋範獵築糧 = 壓願壓齋選觸鹹憲膚鏇獵餘築構選鏇醖憲壓構 (廠糧憲艱鑰醖鹹簾廠顧, 鏇鑰窪遞選範觸積蓋襯 ~ 範範淵襯餘醖鬱憲製壓) 更多	-	2024-08-06
				Pemetrexed+Cisplatin+AZD9291 (Safety Run-In: AZD9291 + Cisplatin + Pemetrexed)	衊鹹獵顧鏇蓋範獵築糧 = 鑰鏇積齋廠膚積選憲鹹獵餘築構選鏇醖憲壓構 (廠糧憲艱鑰醖鹹簾廠顧, 餘醖憲夢窪鬱構艱艱蓋 ~ 壓繭餘鑰範獵觸膚醖顧) 更多