更新于：2024-11-01

metastatic non-small cell lung cancer

转移性非小细胞肺癌

更新于：2024-11-01

基本信息

别名

LUNG CANCER NON SMALL CELL METASTATIC、Lung cancer non-small cell stage IV、Metastatic NSCLC - non-small cell lung cancer

+ [32]

简介

Stage IV includes: (Any T, Any N, M1a); (Any T, Any N, M1b). M1a: Lung cancer with separate tumor nodule(s) in a contralateral lobe; tumor with pleural nodules or malignant pleural (or pericardial) effusion. M1b: Distant metastasis. (AJCC 7th ed.)

关联

558

项与转移性非小细胞肺癌相关的药物

Iparomlimab/Tuvonralimab

艾帕洛利单抗托沃瑞利单抗

靶点

CTLA4 x PD-1

作用机制

CTLA4抑制剂 [+1]

在研机构

齐鲁制药有限公司

原研机构

齐鲁制药有限公司

在研适应症

转移性宫颈癌 [+13]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2024-09-26

Atezolizumab/Hyaluronidase-tqjs

靶点

Hyaluronic acid x PDL1

作用机制

透明质酸调节剂 [+1]

在研机构

Genentech, Inc. [+1]

原研机构

Genentech, Inc.

在研适应症

肺泡软组织肉瘤 [+6]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2024-09-12

Enlonstobart

恩朗苏拜单抗

靶点

PD-1

作用机制

PD-1抑制剂

在研机构

杭州尚健生物技术有限公司初创企业 [+4]

原研机构

石药集团中奇制药技术（石家庄）有限公司

在研适应症

PD-L1阳性宫颈癌 [+15]

非在研适应症

恶性间皮瘤 [+4]

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2024-06-25

2,630

项与转移性非小细胞肺癌相关的临床试验

NCT06568939 / Not yet recruiting临床2期

A Phase 2, Open-Label, Randomized, Global Study of Two Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of Teliso-V in 1 of 2 arms at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin. Approximately 100 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 40 sites worldwide.
Participants will receive IV telisotuzumab vedotin at 1 of 2 doses as part of a 3 year study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

开始日期2025-01-30

申办/合作机构

AbbVie, Inc.

NCT06660407 / Not yet recruiting临床2期IIT

Grid Radiotherapy for Advanced Non-Small Cell Lung Cancer at the Time of Progression on Immune Checkpoint Inhibition

This phase II trial tests the safety and effectiveness of the combination of grid radiation therapy and standard of care (SOC) immunotherapy in treating patients with stage IV non-small lung cancer (NSCLC). Conventional radiation therapy treatments typically deliver the same radiation dose to the entire tumor. Spatially fractionated radiation therapy or grid therapy is approved and a technique which permits the delivery of high doses of radiation to small regions of the tumor which can lead to enhanced tumor cell killing. Grid therapy has been shown to produce dramatic relief of severe symptoms, significant tumor regression (decrease in the size of a tumor), and above average local control rates often exceeding those expected with conventionally delivered radiation treatments, all with minimal associated toxicity. Immunotherapy has become combined into treating patients, which has led improvements in survival and quality of life. Immunotherapy is now the cornerstone of SOC therapy for stage IV NSCLC. Grid radiation therapy combined with immunotherapy may be safe and effective in treating patients with stage IV NSCLC.

开始日期2025-01-15

申办/合作机构

Mayo Clinic

NCT06627738 / Not yet recruiting临床2期IIT

Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost

This is a monocentric, non-randomized, open-label, superiority phase II clinical investigation evaluating the efficacy of additional Cyberknife irradiation after a doublet of Platinum Salts-based chemotherapy and concomitant radiotherapy in patients with locally advanced non-small cell lung carcinoma (NSCLC), with an interim analysis.

开始日期2025-01-01

申办/合作机构

Centre Antoine-Lacassagne

100 项与转移性非小细胞肺癌相关的临床结果

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100 项与转移性非小细胞肺癌相关的转化医学

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0 项与转移性非小细胞肺癌相关的专利（医药）

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15,595

项与转移性非小细胞肺癌相关的文献（医药）

2025-01-01·Gene

Corrigendum to “Exosomes secreted by metastatic cancer cells promotes epithelial mesenchymal transition in non-small cell lung carcinoma: The key role of Src/TGF-β1 axis” [Gene 20 (2024) 147873]

作者: Shen, Yuzhou ; Tantai, Jicheng

Exosome-mediated epithelial mesenchymal transition (EMT) is key to cancer metastasis. c-Src is involved in the secretion of exosomes and initiation of EMT.Effects of exosomes from metastatic non-small cell lung carcinoma (NSCLC) cells on the EMT process in primary NSCLC cells were assessed.Levels of c-Src in NSCLC tissues were detected and the influence of exosomes from metastatic NSCLC cells on the exosome secretion and EMT process in primary NSCLC cells was assessed.The expression of c-Src was modulated, and the influence on the secretion of exosomes and EMT initiation was evaluated.The level of c-Src was higher in NSCLC specimen and NSCLC cells with promoted EMT process.The suppression of c-Src inhibited secretion of exosomes.Exosomes from metastatic NSCLC cells enhanced migration and invasion abilities of primary NSCLC cells, which had identical effects to c-Src overexpression.The suppression of c-Src inhibited growth and metastasis of solid tumors as well as secretion of exosomes, while the injection of exosomes with c-Src overexpression promoted lung metastasis.TGF-β1 restored the invasion and migration abilities even with c-Src knockdown.The exosomes from metastatic NSCLC cells with high c-Src expression of can increase c-Src level in primary NSCLC cells, contributing to the promoted EMT process through TGF-β1 pathway.

2024-12-31·Journal of Medical Economics

Cost of genetic testing, delayed care, and suboptimal treatment associated with polymerase chain reaction versus next-generation sequencing biomarker testing for genomic alterations in metastatic non-small cell lung cancer

Article

作者: Morrison, Laura ; Emond, Bruno ; Hilts, Annalise ; Waters, Dexter ; Lefebvre, Patrick ; Lafeuille, Marie-Hélène ; Vanderpoel, Julie ; He, Andy ; Bestvina, Christine M

AIMSTo assess US payers' per-patient cost of testing associated with next-generation sequencing (NGS) versus polymerase chain reaction (PCR) biomarker testing strategies among patients with metastatic non-small cell lung cancer (mNSCLC), including costs of testing, delayed care, and suboptimal treatment initiation.METHODSA decision tree model considered biomarker testing for genomic alterations using either NGS, sequential PCR testing, or hotspot panel PCR testing. Literature-based model inputs included time-to-test results, costs for testing/medical care, costs of delaying care, costs of immunotherapy [IO]/chemotherapy [CTX] initiation prior to receiving test results, and costs of suboptimal treatment initiation after test results (i.e. costs of first-line IO/CTX in patients with actionable mutations that were undetected by PCR that would have been identified with NGS). The proportion of patients testing positive for a targetable alteration, time to appropriate therapy initiation, and per-patient costs were estimated for NGS and PCR strategies combined.RESULTSIn a modeled cohort of 1,000,000 members (25% Medicare, 75% commercial), an estimated 1,119 had mNSCLC and received testing. The proportion of patients testing positive for a targetable alteration was 45.9% for NGS and 40.0% for PCR testing. Mean per-patient costs were lowest for NGS ($8,866) compared to PCR ($18,246), with lower delayed care costs of $1,301 for NGS compared to $3,228 for PCR, and lower costs of IO/CTX initiation prior to receiving test results (NGS: $2,298; PCR:$5,991). Cost savings, reaching $10,496,220 at the 1,000,000-member plan level, were driven by more rapid treatment with appropriate therapy for patients tested with NGS (2.1 weeks) compared to PCR strategies (5.2 weeks).LIMITATIONSModel inputs/assumptions were based on published literature or expert opinion.CONCLUSIONSNGS testing was associated with greater cost savings versus PCR, driven by more rapid results, shorter time to appropriate therapy initiation, and minimized use of inappropriate therapies while awaiting and after test results.

2024-12-31·European Clinical Respiratory Journal

Incidental pulmonary nodules may lead to a high proportion of early-stage lung cancer: but it requires more than a high CT volume to achieve this

Article

作者: Bodtger, U ; Hilberg, O ; Alstrup, G ; Borg, M ; Arshad, A ; Laursen, C B ; Mamaeva, T ; Rasmussen, T Riis ; Kristensen, K ; Andersen, M Brun

BackgroundThe management of pulmonary nodules plays a critical role in early detection of lung cancer. Computed tomography (CT) has led to a stage-shift towards early-stage lung cancer, but regional differences in survival rates have been reported in Denmark. This study aimed to evaluate whether variations in nodule management among Danish health regions contributed to these differences.Material and MethodsThe Danish Health Data Authority and Danish Lung Cancer Registry provided data on CT usage and lung cancer stage distribution, respectively. Auditing of lung cancer stage IA patient referrals and nodule management of stage IV lung cancer patients was conducted in seven Danish lung cancer investigation centers, covering four of the five Danish health regions. CT scans were performed up to 2 years before the patients' diagnosis from 2019 to 2021.ResultsCT usage has increased steadily in Denmark over the past decade, with a simultaneous increase in the proportion of early-stage lung cancers, particularly stage IA. However, one Danish health region, Region Zealand, exhibited lower rates of early-stage lung cancer and overall survival despite a CT usage roughly similar to that of the other health regions. The audit did not find significant differences in pulmonary nodule management or a higher number of missed nodules by radiologists in this region compared to others.ConclusionThis study suggests that a high CT scan volume alone is not sufficient for the early detection of lung cancer. Factors beyond hospital management practices, such as patient-related delays in socioeconomically disadvantaged areas, may contribute to regional differences in survival rates. This has implications for future strategies for reducing these differences.

2,508

项与转移性非小细胞肺癌相关的新闻（医药）

2024-10-31

·PipelineReview

BridgeBio Oncology Therapeutics (BBOT) Announces First Patient Dosed with First-in-Class BBO-10203, a RAS:PI3Kα Breaker, in the Phase 1 BREAKER-101 Trial for Advanced Solid Tumors

SOUTH SAN FRANCISCO, CA, USA I October 30, 2024 I TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (“BBOT” or the “Company”), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, has announced that the first patient has been dosed with BBO-10203 in the BREAKER-101 trial. BBO-10203 is a first-in-class orally bioavailable RAS:PI3Ka breaker that blocks the interaction between RAS and PI3Kα to inhibit PI3Kα-AKT signaling in tumors, without directly inhibiting the catalytic activity of PI3Kα. “I am thrilled to partner with BBOT to bring a potentially transformable new therapeutic to the clinic,” said Dr. Minal Barve, Chief Medical Officer and Principal Investigator at Mary Crowley Cancer Research, Dallas, TX. “BBO-10203 represents a first-in-class drug with potential to address high unmet medical needs and change the landscape of cancer care. We look forward to evaluating BBO-10203 in the BREAKER-101 trial.” BBO-10203 was designed to bind covalently and selectively to the RAS-binding domain (RBD) of PI3Kα. This selective inhibition is agnostic to the mutational status of PI3Kα and RAS, and in preclinical models, results in complete inhibition of RAS-driven pAKT signal at single digit nanomolar concentration. Additionally, no hyperglycemia was observed in preclinical species treated with BBO-10203. The discovery of BBO-10203 was the result of a collaboration between the RAS Initiative at Frederick National Laboratory, Lawrence Livermore National Laboratory, and BBOT. “BBO-10203 is a first-in-class program that inhibits the interaction of the two most mutated oncogenes in human cancer, and it will allow us to test, for the first time, the importance of RAS-coordinated activation of the MAPK and AKT signaling pathways,” said Pedro Beltran, PhD, Chief Scientific Officer of BBOT. “The discovery of BBO-10203 was made possible by the dedicated collaboration between academic, national laboratory, and industry experts that synergized to advance medicines for patients suffering from cancer.” The BREAKER-101 trial will enroll patients globally with locally advanced or metastatic HER2-positive breast cancer, HR-positive/HER2-negative breast cancer, KRAS mutant advanced colorectal cancer, and KRAS mutant advanced non-small cell lung cancer. “There is a tremendous opportunity to improve the standard of care in oncology by inhibiting oncogenic pAKT signaling without the metabolic side effects observed with kinase inhibitors, and the initiation of the Phase 1 study of BBO-10203 marks an important milestone in this regard,” said Yong (Ben) Ben, MD, Chief Medical and Development Officer of BBOT. “The second IND within six months of establishing BBOT clearly demonstrates our team’s capability in advancing our novel programs into the clinic. This novel mechanism and scientific rationale behind it will allow tremendous combination opportunities that optimally inhibit both pAKT and pERK – an approach we hope will bring unprecedented benefit to patients with RAS-driven cancers.” About TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (BBOT) BridgeBio Oncology Therapeutics (BBOT) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. Initially formed as a subsidiary of BridgeBio, BBOT completed a $200M private financing with external investors in 2024 with the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit bridgebiooncology.com . SOURCE: BridgeBio Oncology Therapeutics

临床1期

2024-10-31

·PRNewswire

CStone Announces MHRA Approval of Sugemalimab for First-Line Treatment of Non-Small Cell Lung Cancer (NSCLC) in the UK

This approval marks the second international marketing authorization for sugemalimab outside of China, following its recent approval by the European Commission. The approval is based on results from the Phase 3 GEMSTONE-302 clinical trial, which demonstrated that sugemalimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) and overall survival (OS) in treatment-naive patients with metastatic NSCLC. Long-term survival data from the GEMSTONE-302 study were presented at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. CStone is actively communicating with regulatory authorities, including the European Medicines Agency (EMA) for marketing authorization applications for additional indications of sugemalimab. CStone has entered into a strategic commercialization partnership with Ewopharma for sugemalimab in Central & Eastern Europe and Switzerland, with further collaborations expected soon in regions including Western Europe, Latin America, the Middle East, and Southeast Asia. SUZHOU, China, Oct. 31, 2024 /PRNewswire/ -- CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved sugemalimab in combination with platinum-based chemotherapy as a first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations. This marks the second overseas approval for sugemalimab following its recent authorization by the European Commission. Dr. Jason Yang, CEO, President of R&D and Executive Director of the Board at CStone, said, "This approval is a significant milestone in our global expansion strategy. Sugemalimab is the first domestic anti-PD-L1 antibody to receive approval outside of China and has already entered the world's second-largest pharmaceutical market, the EU. Now, with the UK approval, sugemalimab continued to expand its presence in the European market. The long-term survival data, recently presented at this year's ESMO Congress, further confirmed sugemalimab's value in the frontline treatment landscape for metastatic NSCLC." Dr. Yang added, "We are actively pursuing additional partnerships across Western Europe, Latin America, the Middle East, Southeast Asia, and Canada, and expect to finalize some of these agreements shortly. Meanwhile, we are communicating with the European Medicines Agency (EMA) and other agencies for additional regulatory applications for other sugemalimab indications, including Stage III NSCLC, first-line gastric cancer, and first-line esophageal squamous cell carcinoma, aiming to bring innovative treatment options to more patients globally." The MHRA's approval is primarily based on the data from GEMSTONE-302, a multicenter, randomized, double-blind phase 3 trial. The study demonstrated that sugemalimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) and overall survival (OS) compared to placebo combined with chemotherapy in treatment-naïve patients with metastatic NSCLC. Study results have been published in The Lancet Oncology and Nature Cancer, and have been presented at multiple international academic conferences in both oral and poster sessions. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准临床结果

2024-10-31

·医药观澜

刚刚！基石药业宣布抗PD-L1单抗在英国获批，一线治疗非小细胞肺癌

▎药明康德内容团队编辑基石药业刚刚宣布，英国药品和医疗保健用品管理局（MHRA）已批准舒格利单抗联合含铂化疗用于无EGFR敏感突变, 或无ALK, ROS1, RET基因组肿瘤变异的转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。这是继欧盟委员会批准之后，舒格利单抗在国际市场获得的第二项上市许可申请的批准。此次获批主要是基于一项多中心、随机、双盲的3期临床研究——GEMSTONE-302的结果。舒格利单抗联合化疗对比安慰剂联合化疗，可显著延长初治转移性NSCLC患者的无进展生存期和总生存期。该研究数据已在《柳叶刀·肿瘤学》和《自然·癌症》上发表，并曾多次在国际学术会议上以口头汇报和壁报形式公布。基石药业首席执行官、研发总裁、执行董事杨建新博士在新闻稿中表示：舒格利单抗在英国获批，标志着公司全球化布局的又一重要里程碑。在今年ESMO上公布的长期生存数据，更是进一步巩固了舒格利单抗在转移性NSCLC一线治疗格局中的重要地位。他还表示，在国际商业化和注册方面，公司正积极与来自西欧、拉美、中东、东南亚、加拿大等地区的合作伙伴洽谈，预计近期将达成其中多项商业合作。同时，公司在积极与欧洲药品管理局（EMA）等国际监管机构沟通舒格利单抗其他适应症，如III期NSCLC、一线胃癌、一线食管鳞癌的上市申请，期待为全球更多患者带来创新的治疗方案。舒格利单抗是由基石药业研发的抗PD-L1单克隆抗体，其独特分子设计使其具备双重作用机制，不仅阻断PD-1/PD-L1相互作用，还能通过介导PD-L1表达阳性的肿瘤细胞与肿瘤相关巨噬细胞（TAMs），在诱导抗体依赖性细胞吞噬（ADCP）的同时不损害效应性T细胞。目前，中国国家药品监督管理局（NMPA）已批准舒格利单抗五项适应症：联合化疗一线治疗转移性鳞状和非鳞状NSCLC患者；治疗同步或序贯放化疗后未出现疾病进展的、不可切除、III期NSCLC患者；治疗复发或难治性结外NK/T细胞淋巴瘤患者；联合氟尿嘧啶类和铂类化疗药物一线治疗不可切除的局部晚期，复发或转移性食管鳞癌患者；联合含氟尿嘧啶类和铂类药物化疗用于表达PD-L1（综合阳性评分[CPS]≥5）的不可手术切除的局部晚期或转移性胃及胃食管结合部腺癌的一线治疗。在国际领域，欧盟委员会（EC）已批准舒格利单抗联合含铂化疗用于无EGFR敏感突变, 或无ALK, ROS1, RET基因组肿瘤变异的转移性NSCLC患者的一线治疗；英国药品和医疗保健用品管理局（MHRA）已批准舒格利单抗联合含铂化疗用于无EGFR敏感突变, 或无ALK, ROS1, RET基因组肿瘤变异的转移性NSCLC患者的一线治疗。参考资料： [1]国产PD-L1首度在英国获批！基石药业宣布舒格利单抗获英国药品和医疗保健用品管理局批准用于一线治疗非小细胞肺癌 Retrieved Oct 31，2024, from https://mp.weixin.qq.com/s/9F1906G2lFkf2ohU-Xm7qg 本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转载授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床3期上市批准临床结果申请上市医药出海