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上皮成長因子受容体(EGFR)エクソン20挿入変異を有する局所進行性または転移性非小細胞肺癌(NSCLC)患者に対するフルモネルチニブとプラチナ製剤ベースの化学療法の比較研究(FURVENT)
基本情報
- NCT ID
- NCT05607550
- ステータス
- 実施中(募集終了)
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 398
- 治験依頼者名
- ArriVent BioPharma, Inc.
概要
Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib (firmonertinib) at 2 dose levels (160 mg once daily \[QD\] and 240 mg QD) compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations. A target of approximately 375 patients will be randomized in a 1:1:1 ratio to treatment with furmonertinib 240 mg QD, furmonertinib 160 mg QD, or platinum-based chemotherapy.
対象疾患
Metastatic Non-Small Cell Lung CancerAdvanced Non-Small Cell Lung CancerEGFR Exon 20 Mutations
介入
furmonertinib 240 mg oral, daily(DRUG)
furmonertinib 160 mg oral, daily(DRUG)
platinum-based chemotherapy(DRUG)
依頼者(Sponsor)
Allist(INDUSTRY)
Arrivent Biopharma(INDUSTRY)