NCT05607550进行中（未招募）3 期
A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Furmonertinib Compared to Platinum-Based Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 398
- 试验地点
- 4
- 主要终点
- Progression Free Survival (PFS) determined by blinded independent central review (BICR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
- •Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.
- •No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
- •Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months.
- •Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.
排除标准
- 未提供
研究组 & 干预措施
furmonertinib 240 mg
Experimental
干预措施: furmonertinib 240 mg oral, daily (Drug)
furmonertinib 160 mg
Experimental
干预措施: furmonertinib 160 mg oral, daily (Drug)
platinum-based chemotherapy
Active Comparator
carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously
干预措施: platinum-based chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival (PFS) determined by blinded independent central review (BICR)
时间窗: Up to 32 months after first dose
次要结局
- Duration of response (DOR)(Up to 36 months after first dose)
- Time to second Progression Free Survival (PFS2)(Up to 36 months after first dose)
- PFS by blinded independent central review (BICR) in patients with a history or presence of brain metastases at baseline(Up to 36 months after first dose)
- CNS ORR evaluated by BICR(Randomization up to ≤30 days after last dose)
- Overall Survival (OS)(Up to 62 months after first dose)
- PFS determined by investigator assessment(Up to 36 months after first dose)
- Overall response rate (ORR)(Up to 36 months after first dose)
- Time to central nervous system (CNS) metastases by BICR(Randomization up to ≤30 days after last dose)
- CNS DOR evaluated by BICR(Randomization up to ≤30 days after last dose)
- CNS PFS evaluated by BICR(Randomization up to ≤30 days after last dose)
- Change in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ)(Randomization up to ≤30 days after last dose)
- Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib(Up to 36 months after first dose)
- Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)(Randomization up to ≤30 days after last dose)
- Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13)(Randomization up to ≤30 days after last dose)
- Plasma concentrations of furmonertinib and its major metabolite (AST5902)(Up to 36 months after first dose)
研究者
研究点 (4)
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相关资讯
ArriVent Advances Firmonertinib Toward Pivotal EGFR Exon 20 NSCLC Data as ADC Pipeline Progresses- ArriVent BioPharma expects topline data from the global pivotal FURVENT Phase 3 trial of firmonertinib in first-line EGFR exon 20 insertion mutant NSCLC in the second half of 2026.
- The company advanced ARR-217, a CDH17-targeted ADC for gastrointestinal cancers, into Phase 1b dose optimization and plans first-patient dosing for ARR-002, a dual-targeting MUC16/NaPi2b ADC, in Q3 2026.
- Firmonertinib holds FDA Breakthrough Therapy and Orphan Drug designations and is also being studied in the ALPACCA Phase 3 trial for EGFR PACC-mutant NSCLC.
- ArriVent reported $373.1 million in cash and investments as of June 30, 2026, expected to fund operations into 2028.last monthEGFR Inhibitors Market Poised for 7.9% CAGR Growth Through 2036, Driven by Next-Generation TKIs, ADCs, and Bispecific Antibodies- The global EGFR inhibitors market reached USD 7 billion in 2025 across the 7MM, with the United States accounting for approximately 60% of total market share.
- A wave of emerging therapies including zipalertinib, firmonertinib, ivonescimab, and multiple ADC candidates is expected to reshape the treatment landscape for EGFR-mutated cancers.
- The FDA has set PDUFA action dates for ivonescimab (November 14, 2026) and zipalertinib (February 27, 2027), signaling imminent regulatory decisions for two novel agents.
- EGFR exon 20 insertion mutations have emerged as a key competitive arena, with approvals of amivantamab and sunvozertinib creating a distinct market segment.3 months ago