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Clinical Trials in Italy / NCT05607550
Active, not recruiting Phase 3

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)

NCT05607550 · tracked via the Priya Life Science Italy tracker
Sponsor
ArriVent BioPharma, Inc
Phase
Phase 3
Started
2023-06-01
Last updated
2025-06-22

Condition(s) studied

Metastatic Non-Small Cell Lung CancerAdvanced Non-Small Cell Lung CancerEGFR Exon 20 Mutations

Investigational drug(s) / intervention(s)

furmonertinib 240 mg oral, daily →furmonertinib 160 mg oral, daily →platinum-based chemotherapy

furmonertinib 240 mg oral, daily: furmonertinib tablet

furmonertinib 160 mg oral, daily: furmonertinib tablet

platinum-based chemotherapy: (carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Progression Free Survival (PFS) determined by blinded independent central review (BICR) — Up to 32 months after first dose

Trial sites (208)

FacilityCityRegionStatus
Arrivent Investigative Site Daphne Alabama
Arrivent Investigative Site Yuma Arizona
Arrivent Investigative Site Fayetteville Arkansas
Arrivent Investigative Site Beverly Hills California
Arrivent Investigative Site Fullerton California
Arrivent Investigative Site Long Beach California
Arrivent Investigative Site Los Alamitos California
Arrivent Investigative Site Napa California
Arrivent Investigative Site Orange California
Arrivent Investigative Site Orange California
Arrivent Investigative site Sacramento California
Arrivent Investigative Site San Diego California
Arrivent Investigative Site Santa Barbara California
Arrivent Investigative Site Santa Monica California
Arrivent Investigative Site Santa Rosa California
Arrivent Investigative Site Whittier California
Arrivent Investigative Site Hartford Connecticut
Arrivent Investigative Site Norwich Connecticut
Arrivent Investigative Site Fort Myers Florida
Arrivent Investigative Site St. Petersburg Florida
Arrivent Investigative Site The Villages Florida
Arrivent Investigative Site Peoria Illinois
Arrivent Investigative Site Rolling Meadows Illinois
Arrivent Investigative Site Fort Wayne Indiana
Arrivent Investigative Site Indianapolis Indiana
Arrivent Investigative Site South Bend Indiana
Arrivent Investigative Site Bethesda Maryland
Arrivent Investigative Site Frederick Maryland
Arrivent Investigative Site Rockville Maryland
Arrivent Investigative Site Fairhaven Massachusetts
Arrivent Investigative Site Lansing Michigan
Arrivent Investigative Site Bolivar Missouri
Arrivent Investigative Site Kansas City Missouri
Arrivent Investigative Site Saint Joseph Missouri
Arrivent Investigative Site St Louis Missouri
Arrivent Investigative Site Omaha Nebraska
Arrivent Investigative Site Belleville New Jersey
Arrivent Investigative Site Englewood New Jersey
Arrivent Investigative Site Florham Park New Jersey
Arrivent Investigative Site The Bronx New York

+ 168 more sites — see the full list on the official registry below.

More ArriVent BioPharma, Inc. trials in Italy

Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations Recruiting
Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations Active, not recruiting

Other trials for the same condition

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) Active, not recruiting
A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer Recruiting
A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer. Active, not recruiting
LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC Recruiting
Study With Various Immunotherapy Treatments in Participants With Lung Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05607550 on ClinicalTrials.gov ↗ ← All trials in Italy