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)

ArriVent BioPharma logo

ArriVent BioPharma

Status and phase

Enrolling
Phase 3

Conditions

Metastatic Non-Small Cell Lung Cancer
EGFR Exon 20 Mutations
Advanced Non-Small Cell Lung Cancer

Treatments

Drug: furmonertinib 240 mg oral, daily
Drug: furmonertinib 160 mg oral, daily
Drug: platinum-based chemotherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT05607550
FURMO-004
2022-502977-41-00

Details and patient eligibility

About

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.

Enrollment

375 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

375 participants in 3 patient groups

furmonertinib 240 mg
Experimental group
Treatment:
Drug: furmonertinib 240 mg oral, daily
furmonertinib 160 mg
Experimental group
Treatment:
Drug: furmonertinib 160 mg oral, daily
platinum-based chemotherapy
Active Comparator group
Description:
carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously
Treatment:
Drug: platinum-based chemotherapy

Trial contacts and locations

198

Loading...

Central trial contact

Vanessa Esquibel

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems