Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 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)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Metastatic Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer EGFR Exon 20 Mutations

Спонсор: ArriVent BioPharma, Inc.

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Места на провеждане 19
Австралия (1)
ArriVent Investigative Site
Heidelberg , Victoria
Бразилия (1)
ArriVent Investigative Site
Salvador , Estado de Bahia
Канада (1)
ArriVent Investigative Site
Edmonton , Alberta
Китай (1)
Allist Investigative Site
Beijing , Beijing Municipality
Франция (1)
Arrivent Investigative Site
Caen
Израел (1)
ArriVent Investigative Site
Beersheba
Италия (1)
ArriVent Investigative Site
Rozzano , Milan
Япония (1)
ArriVent Investigative Site
Kurume , Fukuoka
Malaysia (1)
ArriVent Investigative Site
George Town , Pulau Pinang
Mexico (1)
ArriVent Investigative Site
Tuxtla Gutiérrez , Chiapas
Нидерландия (1)
Arrivent Investigative Site
Amsterdam
Philippines (1)
Arrivent Investigative Site
Cebu
Сингапур (1)
ArriVent Investigative Site
Singapore
Южна Корея (1)
ArriVent Investigative Site
Jungni I Gu , Seoul
Испания (1)
ArriVent Investigative Site
Málaga , Malaga
Taiwan (1)
Arrivent Investigative Site
Chang-hua
Тайланд (1)
Arrivent Investigative Site
Bangkok
Великобритания (1)
ArriVent Investigative Site
Guildford , Surrey
САЩ (1)
Arrivent Investigative Site
Daphne , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.06.2023
Крайна дата
15.02.2028
Регистрационен номер
NCT05607550
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.