Study Comparing Furmonertinib to Chemotherapy for Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Sponsor: ArriVent BioPharma, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT05607550

This clinical trial is testing a new drug, furmonertinib, against standard chemotherapy to see which is more effective and safer for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation.

Patient Parameters

Program Overview

This study is a global Phase 3 trial that aims to compare the effectiveness and safety of a new drug called furmonertinib, taken once daily at two different doses, with standard platinum-based chemotherapy. It focuses on patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have a specific genetic mutation known as EGFR exon 20 insertion. The trial will include about 375 patients who have not received previous treatment for their advanced cancer, and they will be randomly assigned to receive either furmonertinib or chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Have advanced non-squamous non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiotherapy.
  • Have a confirmed genetic mutation called EGFR exon 20 insertion in the cancer cells, identified through tests on tumor tissue or blood.
  • Have not received any previous systemic treatment for advanced NSCLC, including drugs targeting EGFR.
  • If previously treated with chemotherapy, immunotherapy, or chemo-radiotherapy for non-metastatic cancer, must have had at least a 12-month break since the last treatment.
  • Can have a history of treated brain metastases or new brain metastases that are not causing symptoms.

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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