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Active (not recruiting) Phase 3 NCT05607550

Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

Phase 3 – large-scale trial before approval
Conditions: Metastatic Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer EGFR Exon 20 Mutations

Sponsor: ArriVent BioPharma, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
Key Inclusion Criteria: * 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.
Locations 19
Australia (1)
ArriVent Investigative Site
Heidelberg , Victoria
Brazil (1)
ArriVent Investigative Site
Salvador , Estado de Bahia
Canada (1)
ArriVent Investigative Site
Edmonton , Alberta
China (1)
Allist Investigative Site
Beijing , Beijing Municipality
France (1)
Arrivent Investigative Site
Caen
Israel (1)
ArriVent Investigative Site
Beersheba
Italy (1)
ArriVent Investigative Site
Rozzano , Milan
Japan (1)
ArriVent Investigative Site
Kurume , Fukuoka
Malaysia (1)
ArriVent Investigative Site
George Town , Pulau Pinang
Mexico (1)
ArriVent Investigative Site
Tuxtla Gutiérrez , Chiapas
Netherlands (1)
Arrivent Investigative Site
Amsterdam
Philippines (1)
Arrivent Investigative Site
Cebu
Singapore (1)
ArriVent Investigative Site
Singapore
South Korea (1)
ArriVent Investigative Site
Jungni I Gu , Seoul
Spain (1)
ArriVent Investigative Site
Málaga , Malaga
Taiwan (1)
Arrivent Investigative Site
Chang-hua
Thailand (1)
Arrivent Investigative Site
Bangkok
United Kingdom (1)
ArriVent Investigative Site
Guildford , Surrey
United States (1)
Arrivent Investigative Site
Daphne , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.06.2023
Completion date
15.02.2028
Registry ID
NCT05607550
Source
anzctr
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