Ph3 open label study of Furmonertinib FURMO-004

• Research type

  Research Study

• Full title

  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 with Epidermal Growth Factor Receptor Exon 20 Insertion Mutations

• IRAS ID

  1007082

• Contact name

  Jerry Hsu

• Contact email

  HsuJ@arrivent.com

• Sponsor organisation

  ArriVent BioPharma, Inc.

• Eudract number

  2022-002006-24

• Clinicaltrials.gov Identifier

  NCT05607550

• Research summary

  The purpose of this study is to learn about how the study drug, furmonertinib, works in participants with non-small cell lung cancer (NSCLC) who have a mutation in a specific gene and how it may help them.
  For participants with this type of NSCLC, the study will help researchers to learn how safe the study drug is, to learn how effective two different doses of the study drug are, and to compare the effects, good or bad, of the different doses of the study drug compared to standard chemotherapy treatment.
  Globally, lung cancer is the second most commonly diagnosed cancer and the leading cause of cancer-related deaths among men and women, with an estimated 2.2 million new cancer cases and 1.8 million deaths reported in 2020. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases.
  Up to about 375 men and women (aged 18 years or over) with NSCLC may take part in this study.
  Patients that have NSCLC that cannot be cured by surgery or radiation would be eligible to take part.
  This study has three parts:
  1. Screening (to see if the participant is eligible for the study)
  2. Treatment
  3. Follow-up (to check on the participant after treatment is finished)
  The total time for a participant to be in the study will depend on how their lung cancer responds to treatment. This could range from 1 day to up to 60 months.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  23/LO/0180

• Date of REC Opinion

  10 Oct 2023

• REC opinion

  Further Information Favourable Opinion