Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
ArriVent BioPharma, Inc. (Voir sur ClinicalTrials)
juin 2023
février 2028
24 juin 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | David PLANCHARD | 30/05/2024 18:08:04 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Arrivent Investigative Site - 13915 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Arrivent Investigative Site - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Arrivent Investigative Site - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Arrivent Investigative Site - 69003 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Arrivent Investigative Site - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Arrivent Investigative Site - 94800 - Villejuif - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.