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)

Sponsor: ArriVent BioPharma, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT05607550

This Phase 3 study evaluates furmonertinib at 160 mg and 240 mg daily against platinum-based chemotherapy in untreated, advanced NSCLC patients with EGFR exon 20 mutations. Eligible participants must have documented mutations, no prior systemic therapy for advanced NSCLC, and may have treated or asymptomatic CNS metastases. Interventions include furmonertinib tablets and platinum-based chemotherapy.

Patient Parameters

Program 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.

Eligibility Criteria

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

FACILITYZIPCITYSTATE
Arrivent Investigative Site36526DaphneAlabama
Arrivent Investigative Site85364YumaArizona
Arrivent Investigative Site72703FayettevilleArkansas
Arrivent Investigative Site90212Beverly HillsCalifornia
Arrivent Investigative Site92835FullertonCalifornia
Arrivent Investigative Site90806Long BeachCalifornia
Arrivent Investigative Site90720Los AlamitosCalifornia
Arrivent Investigative Site94558NapaCalifornia
Arrivent Investigative Site90868OrangeCalifornia
Arrivent Investigative Site92868OrangeCalifornia

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