主要目的：评估BEBT-109联合培美曲塞和卡铂或顺铂一线治疗携带EGFR 20号外显子插入突变的局部晚期、复发或转移性非小细胞肺癌的安全性。次要目的：评估BEBT-109联合培美曲塞和卡铂或顺铂一线治疗携带EGFR 20号外显子插入突变的局部晚期、复发或转移性非小细胞肺癌的有效性；评估BEBT-109联合培美曲塞和卡铂或顺铂一线治疗携带EGFR 20号外显子插入突变的局部晚期、复发或转移性非小细胞肺癌患者中药代动力学特征。

开始日期2024-08-22

申办/合作机构

广州必贝特医药技术有限公司

NCT06514027 / Not yet recruiting临床2期

A Multicenter, Open Phase II Clinical Study on the Safety and Efficacy of BEBT-109 Combined With Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations

This is a multicenter, open Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of BEBT-109 combined with injectable pemetrexed disodium and carboplatin or cisplatin injection as first-line treatment for locally advanced, recurrent, or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.

开始日期2024-07-01

申办/合作机构

广州必贝特医药技术有限公司

ChiCTR2200059127 / Suspended临床2期IIT

A Multicenter, Open-label Phase II Trial to Evaluate the Efficacy and Safety of BEBT-109 in Patients with Locally Advanced or Metastatic Cancer of the EGFR 20 Exon Insertion Mutation

开始日期2022-05-16

申办/合作机构-

100 项与 EGFR-G719X 相关的临床结果

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100 项与 EGFR-G719X 相关的转化医学

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0 项与 EGFR-G719X 相关的专利（医药）

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项与 EGFR-G719X 相关的文献（医药）

2024-08-15·Heliyon

Afatinib as first-line treatment for advanced lung squamous cell carcinoma harboring uncommon EGFR G719C and S768I co-mutation: A case report and literature review.

Article

作者: Chen, Yanqiong ; Wang, Fang ; Zhang, Chao ; Zhang, Wen ; Lv, Jialing ; Deng, Ruoyu ; Jiang, Chengqi ; Guan, Yaling

Ten percent of non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations harbor uncommon variants. These mutations are mainly involved in lung adenocarcinomas but are rare in lung squamous cell carcinoma (LSCC). In 2018, the Food and Drug Administration-approved afatinib for this specific patient population. However, there is limited information regarding the effectiveness of afatinib for LSCC with EGFR mutations. This case report documented a unique case of a patient with LSCC, which had a rare compound EGFR mutation (G719C and S768I) and showed significant response to afatinib treatment, with 10 months of progression-free survival. New NTRK1 and RET gene mutations may play a potential role in the development of acquired resistance to afatinib following clinical progression. This case highlights the importance of genetic profiling in patients with LSCC. Although these patients have a low positive rate of EGFR mutations, searching for EGFR mutations in these patients might broaden their treatment options.

2024-03-01·Heliyon

Successful therapy of a critically ill non-small cell lung cancer patient with compound mutations in EGFR G719X and S768I genes using furmonertinib: A case report

作者: Pan, Xue ; Shi, Minhua

BackgroundSomatic mutations in epidermal growth factor receptor (EGFR) genes, such as G719X and S768I, and tyrosine kinase inhibitors (TKIs) have been confirmed to be promising for developing new targeted therapies against advanced non-small-cell lung cancer (NSCLC). The G719X and S768I mutations are uncommon and often occur in the form of compound mutations. However, the efficacy of furmonertinib in patients with these uncommon compound mutations has not yet been elucidated.Case presentationIn this study, the G719X/S768I compound mutations were detected in a critically ill NSCLC patient. This patient received furmonertinib for 14 months and successfully responded to the treatment. The present case report highlights the ideal clinical response, with ongoing follow-up.ConclusionWe report the successful treatment of a critically ill NSCLC patient carrying rare compound EGFR G719X and S768I mutations using furmonertinib. To the best of our knowledge, this is the first reported case of a successful furmonertinib treatment of compound EGFR G719X and S768I mutations. Furmonertinib, a third-generation EGFR-TKI, may be effective in controlling the EGFR G719X and S768I compound mutations in NSCLC.

2023-11-02·British Journal of Neurosurgery

Intraventricular metastases from lung adenocarcinoma-comment on paper by Kong et al .

Letter

作者: Deng, Xueyun ; Liu, Lihua

We read the article ‘Multiple intraventricular metastases from lung adenocarcinoma with EGFR G719X mutation: a case report’ by Kong et al.1 with interest. The paper is very interesting and well wri...

项与 EGFR-G719X 相关的新闻（医药）

2024-10-15

·GlobeNewswire-Health Care

NMPA Grants Marketing Approval to the First Co-Developed NGS-Based Companion Diagnostic for Lung Cancer in China

Oct. 10, 2024 -- Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), an innovative company in the field of precision oncology, and Dizal, a global biopharmaceutical company focused on malignant tumors and immunological diseases, jointly announced that the companion diagnostic (CDx) for EGFR exon 20 insertion mutation (exon20ins) for sunvozertinib, developed through their collaboration, has been approved by the National Medical Products Administration (NMPA) of China. This marks the first co-developed NGS-based CDx for lung cancer approved by NMPA since the release of the CDx guideline in China. The approval of this CDx test is the result of the simultaneous development of Burning Rock's independently developed LungCure CDx (a kit for the combined detection of 9 human gene mutations) and Dizal's innovative EGFR exon20ins targeted therapy - sunvozertinib, providing an innovative precision treatment solution for non-small cell lung cancer patients with EGFR exon20ins. Mr. Yusheng Han, Founder and CEO of Burning Rock stated: "We are thrilled to have carried out a deep companion diagnostic collaboration with the global biopharmaceutical company Dizal. This collaboration sets a standardized and high-quality benchmark for the concurrent development of companion diagnostics for anti-tumor drugs. Burning Rock is strategically positioned to drive companion diagnostic development on a global scale for pharmaceutical companies. By integrating our resources and experience in the field of oncology diagnosis and treatment, we are confident that we can offer more precise treatment options for Chinese cancer patients." Dr. Xiaolin Zhang, Founder, Chairman, and CEO of Dizal stated: “This achievement can be attributed to the collaborative innovation of the professional teams from both sides and reflects our unremitting pursuit of creating clinical value for the benefit of patients. Precision therapy is one of the core strategies of Dizal. Dizal will continue to adhere to the discovery and development of groundbreaking new medicines, and work with our partners to bring new hope of precision treatment to more patients.” Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval was based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The primary endpoint of the study was the confirmed objective response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 61%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. Two global pivotal studies are ongoing in ≥ second-line (WU-KONG1 Part B) and first-line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins. Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2). On March 11, 2022, the National Medical Products Administration (NMPA) officially approved the registration of the company's Human Nine-Gene Mutation Joint Detection Kit (reversible termination sequencing) (commercially known as "LungCure CDx") as a Class III medical device product. This test kit is Burning Rock’s second NMPA-approved companion diagnostic multi-gene tumor mutation co-detection test kit based on high-throughput sequencing technology and meeting companion diagnostic standards. It can be used for in vitro detection of multiple mutation statuses of EGFR, MET, ERBB2, KRAS, BRAF, PIK3CA, ALK, ROS1, and RET genes in non-small cell lung cancer patients, including point mutations, insertions/deletions, fusions (rearrangements), amplifications, etc., to comprehensively guide targeted therapy for non-small cell lung cancer. "LungCure CDx" has undergone rigorous clinical validation, enhancing the detection capability of rare mutation types. At the same time, "LungCure CDx" has entered into companion diagnostics development strategic partnerships with several well-known domestic and international pharmaceutical companies to jointly promote the development of standardized and precise diagnosis and treatment in oncology. Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two leading assets in global pivotal studies, both of which have already been launched in China. Burning Rock Biotech Limited (NASDAQ:BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of 1) NGS-based therapy selection testing for late-stage cancer patients, 2) Global pharmaceutical services on biomarker detection and companion diagnostics development, and 3) Early cancer detection which has moved beyond proof-of-concept R&D into the clinical validation stage. Burning Rock provides dedicated services to pharmaceutical partners, encompassing genomic data solutions, clinical trial solutions, precision patient recruitment, and companion diagnostics development and commercialization. Burning Rock has achieved two NMPA-approved IVD kits, four assays with CE marking, and a breakthrough device designation (BDD) received from both US FDA and China NMPA for multi-cancer detection blood test. The content above comes from the network. if any infringement, please contact us to modify.