BRAF V600-mutated Lung Carcinoma Treated With the Combination of Dabrafenib-trametinib: a Retrospective Evaluation (Secondary Data Use Study of Dabrafenib-Trametinib in "Real Life" for Non-Small Cell Lung Cancer With a BRAF V600 Mutation)

BLaDE cohort will evaluate overall survival (OS), real world progression-free survival (PFS), best response and duration of treatment in patients with advanced, metastatic Non-Small Cell Lung Cancer (NSCLC) harboring BRAF V600E or non E mutation who received dabrafeninb-trametinib combination or not. Subsequent or previous treatments (treatments delivered after or before dabrafeninb-trametinib combination will be recorded). Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

开始日期2021-03-08

申办/合作机构

Intergroupe Francophone Cancerologie Thoracique

[+1]

NCT04452877

/ Completed临床2期

An Open-Label, Single-arm Study to Evaluate the Safety and Efficacy of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the safety and efficacy of dabrafenib in combination with trametinib in Chinese patients with BRAF V600E mutation-positive metastatic Non-Small Cell Lung Cancer. The general study design has been discussed and agreed with Chinese Health Authority and is applying a similar design used for global pivotal phase II study (BRF113928).

开始日期2020-08-19

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT01336634

/ Completed临床2期

A Phase II Study of the BRAF Inhibitor Dabrafenib as a Single Agent and in Combination With the MEK Inhibitor Trametinib in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer

This was a Phase II, multicenter, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects with BRAF mutant advanced non-small cell lung cancer. Central confirmation testing for the BRAF V600E mutation was performed and a sufficient number of subjects were enrolled with the intent of having at least 125 centrally confirmed subjects among the three cohorts.

开始日期2011-08-05

申办/合作机构

Novartis Pharmaceuticals Corp.

100 项与 BRAF V600突变阳性非小细胞肺癌相关的临床结果

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100 项与 BRAF V600突变阳性非小细胞肺癌相关的转化医学

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0 项与 BRAF V600突变阳性非小细胞肺癌相关的专利（医药）

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项与 BRAF V600突变阳性非小细胞肺癌相关的文献（医药）

2025-04-01·eBioMedicine

Prevalence, genetic variations and clinical outcomes of BRAF-V600 mutated advanced NSCLC in China: a retrospective real-world multi-centre study

Article

作者: Li, Jianjie ; Li, Yong ; Shi, Minmin ; Wang, Xi ; Yang, Xue ; Wang, Shuo ; Wang, Yuyan ; Jia, Bo ; Jiang, Caihong ; Zhang, Jiwei ; Li, Honglin ; Zhang, Fengyuan ; Jin, Bo ; Wang, Jingjing ; Liu, Yiliang ; An, Tongtong ; Chi, Yujia ; Lu, Lin ; Zhai, Xiaoyu ; Zhao, Jun ; Man, Li ; Shen, Fengqian ; Jin, Xin ; Wang, Ziping ; Wang, Zhen ; Wang, Yanlei ; Liu, Zhiliang ; Nuersulitan, Reyizha ; Zhuo, Minglei ; Zhang, Mengmeng ; Chen, Hanxiao ; Guan, Guohui ; Zhao, Yanbin ; Tai, Yidi ; Wang, Yudong ; Yan, Jingjing ; Liu, Xiuju

BACKGROUNDDue to the low incidence of BRAF mutations, limited data is available about their prevalence and clinical characteristics. Moreover, comparative real-world efficacy of dabrafenib combined with trametinib versus other treatment regimens, especially in Chinese patients, is also lacking.METHODSPatients who had BRAF genetic testing from the Lung Cancer Big Data Precise Treatment Collaboration Group (LANDSCAPE) database were included as Cohort I. The LANDSCAPE database comprises next-generation sequencing (NGS) data of 175,336 patients with lung cancer, originating from 6 Chinese genetic testing institutions. Cohort II included patients with unresectable locally advanced or metastatic NSCLC with a primary BRAF mutation from 19 centres in China from December 2015 to September 2022.FINDINGSIn Cohort I, of patients with NSCLC, 6249 (3.56%, 95% CI: 3.48%-3.65%) were confirmed to harbour a BRAF mutation. BRAF V600E accounted for 24.6% (1539/6249) of all patients with BRAF-mutated NSCLC. In Cohort II, a total of 129 patients with locally advanced or metastatic BRAF-mutated NSCLC were included. Of 112 patients who received NGS testing, 80 (71.4%) patients had concomitant mutations. The median first-line real-world progression-free survival (rwPFS) of dabrafenib plus trametinib for patients with BRAF V600 mutations was 25.0 months (N = 37), which was numerically longer than first-line immunotherapy-based therapy (N = 12, 15.7 months), and chemotherapy (N = 17, 9.2 months).INTERPRETATIONThis study indicates that dabrafenib plus trametinib could be considered as the optimal treatment option for Chinese patients with NSCLC harbouring BRAF V600 mutations.FUNDINGNational Natural Science Foundation of China (82072583); Beijing Municipal Administration of Hospitals Incubating Program (PX2020044); Beijing Hospitals Authority Youth Programme (QML20231113); Science Foundation of Peking University Cancer Hospital (2022-17); Peking University Cancer Hospital Inner Mongolia Hospital Public Hospital Reform and High-Quality Development Demonstration Project (Gastrointestinal Cancer + Thoracic Cancer) Research Fund (2024YNYB006).

2024-12-01·Translational Lung Cancer Research

Efficacy, safety, and quality of life of dabrafenib plus trametinib treatment in Chinese patients with BRAFV600E mutation-positive metastatic non-small cell lung cancer

Article

作者: Yu, Yan ; Zhou, Jianying ; Wang, Jialei ; Chen, Jun ; Li, Haifu ; Yang, Nong ; Zhang, Li ; Passos, Vanessa Q ; Fan, Yun ; Li, Juan ; Zhao, Yuanyuan ; Zhao, Jun ; Wang, Zhehai ; Zhu, Tong ; Bury-Maynard, Denise

BackgroundDabrafenib plus trametinib (Dab + Tram) is an approved targeted therapy in patients with BRAF ^V600+ mutated metastatic non-small cell lung cancer (NSCLC). Here, we report the efficacy, safety, and quality of life (QoL) results of Dab + Tram treatment in Chinese patients with BRAF ^V600E mutation-positive metastatic NSCLC.MethodsThis is a single-arm, open-label, multicentre, phase II study (NCT04452877). Patients received dabrafenib 150 mg twice daily plus trametinib 2 mg once daily. The primary endpoint was overall response rate (ORR) by central independent review per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria. Secondary endpoints included ORR by investigator assessment, progression-free survival (PFS), duration of response (DOR), overall survival (OS), safety, tolerability, and QoL.ResultsAt the data cut-off (March 11, 2021), 18 of 20 enrolled patients were still receiving treatment. The median age was 64 years; majority were female (55%), non-smokers (55%), and had ≥3 metastatic sites (70%). Nine patients received prior anticancer therapy in a therapeutic or metastatic setting. The median duration of follow-up was 5 months. The ORR by both central and investigator assessment was 75% [95% confidence interval (CI): 50.9-91.3%]. The median DOR, PFS, and OS were not reached/estimable at the cut-off date. The most common treatment-related adverse events (AEs) (all grades, in ≥30% of patients) were pyrexia, increased aspartate aminotransferase (AST), decreased neutrophil count, and decreased white blood cell (WBC) count. The self-reported QoL was improved or maintained during the treatment period.ConclusionsDab + Tram treatment is safe, effective, and can preserve or improve QoL in majority of Chinese patients with BRAF ^V600E mutation-positive metastatic NSCLC. The results are consistent with the global phase II study.

2024-07-29·Future Oncology

Dabrafenib-trametinib in BRAF V600-mutated non-small-cell lung cancer: a single center real world experience

Article

作者: Bernardini, Laura ; Carrozzi, Laura ; Petrini, Iacopo ; Cappelli, Sabrina ; Chella, Antonio ; Massa, Valentina ; Sbrana, Andrea

Aim: We retrospectively evaluated the effect of dabrafenib/trametinib combination in patients with BRAF-mutated non-small-cell lung cancer (NSCLC) treated in a single center from 2017 to 2022.Patients: The response and safety data of 42 patients (27 treated in first-line and 15 as second/subsequent lines) were analyzed.Results: The objective response was 73.8%, with no differences between patients undergoing first- or second-line. A longer, statistically significant median progression-free survival (PFS) was observed in patients receiving the combination in first-line vs those in the second/subsequent lines (19.9 months [95% CI: 19.7-20] vs 13.1 months [95% CI: 8.6-17.6], respectively; p = 0.012). The median overall survival (OS) was 29.9 months (95% CI: 14.1-45.7) for patients treated with the combination in first-line and 22.4 months (95% CI: 14.6-30.2) for those treated in subsequent lines. The combination was well toleratedConclusion: We confirm the efficacy of dabrafenib/trametinib in BRAF-V600-mutated NSCLC.

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