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RecruitingLast updated: 2 February 2024

FURVENT: This study is evaluating how safe and effective targeted therapy is compared to chemotherapy in people with locally advanced or metastatic non-small cell lung cancer with EGFR Exon 20 Insertion mutationsA 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 (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

Clinical summary

Summary

This is a randomised study that is recruiting people with locally advanced or metastatic non-squamous cell non-small cell lung cancer who have not had any prior systemic treatment for their advanced disease.

Eligible participants will be randomly allocated to one of three experimental treatment arms.

  • In Experimental Arm A, participants will receive furmonertinib targeted therapy at a dose of 160 mg orally, daily.
  • In Experimental Arm B, participants will receive furmonertinib targeted therapy at a dose of 240mg orally, daily.
  • In Experimental Arm C, participants will receive platinum-based chemotherapy, which will consist of carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously.

 

Conditions

This trial is treating patients with locally advanced or metastatic non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

Trial Acronym

FURVENT

More information

Trial Identifiers

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Trial sponsor

ArriVent BioPharma, Inc.

Scientific 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 (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

Eligibility

Inclusion

  • 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.

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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