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Active, Not Recruiting

NCT Number: NCT05607550

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)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Metastatic Non-small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung EGFR Exon 20 Mutations Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ArriVent Investigative Site, Heidelberg, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

furmonertinib 240 mg oral, daily

Drug

furmonertinib tablet

Other names: AST2818

furmonertinib 160 mg oral, daily

Drug

furmonertinib tablet

Other names: AST2818

Platinum-based Chemotherapy

Drug

(carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)

Primary outcomes

  1. Progression Free Survival (PFS) determined by blinded independent central review (BICR)

    Time frame: Up to 32 months after first dose

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 62 months after first dose

  2. PFS determined by investigator assessment

    Time frame: Up to 36 months after first dose

  3. Overall response rate (ORR)

    Time frame: Up to 36 months after first dose

  4. Duration of response (DOR)

    Time frame: Up to 36 months after first dose

  5. Time to second Progression Free Survival (PFS2)

    Time frame: Up to 36 months after first dose

  6. PFS by blinded independent central review (BICR) in patients with a history or presence of brain metastases at baseline

    Time frame: Up to 36 months after first dose

  7. Time to central nervous system (CNS) metastases by BICR

    Time frame: Randomization up to ≤30 days after last dose

  8. CNS ORR evaluated by BICR

    Time frame: Randomization up to ≤30 days after last dose

  9. CNS DOR evaluated by BICR

    Time frame: Randomization up to ≤30 days after last dose

  10. CNS PFS evaluated by BICR

    Time frame: Randomization up to ≤30 days after last dose

  11. Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)

    Time frame: Randomization up to ≤30 days after last dose

    QLQ-C30 is a cancer-specific questionnaire comprised of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).

  12. Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13)

    Time frame: Randomization up to ≤30 days after last dose

    QLQ-LC13 is a cancer-specific questionnaire which comprises of 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication.

  13. Change in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ)

    Time frame: Randomization up to ≤30 days after last dose

    NSCLC-SAQ consists of 7 items assessing 5 NSCLC symptom concepts: cough, pain, dyspnea, fatigue, and poor appetite.

  14. Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib

    Time frame: Up to 36 months after first dose

  15. Plasma concentrations of furmonertinib and its major metabolite (AST5902)

    Time frame: Up to 36 months after first dose

Sponsors and collaborators

Lead sponsor

ArriVent BioPharma, Inc.

Industry

Collaborators

  • Allist Pharmaceuticals, Inc.

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Nov 7, 2022
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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