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Trial record 1 of 1 for:    FURMO-004
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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)

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ClinicalTrials.gov Identifier: NCT05607550
Recruitment Status : Recruiting
First Posted : November 7, 2022
Last Update Posted : April 17, 2024
Sponsor:
Collaborator:
Allist Pharmaceuticals, Inc.
Information provided by (Responsible Party):
ArriVent BioPharma, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer EGFR Exon 20 Mutations Drug: furmonertinib 240 mg oral, daily Drug: furmonertinib 160 mg oral, daily Drug: platinum-based chemotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : August 15, 2025
Estimated Study Completion Date : February 15, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: furmonertinib 240 mg Drug: furmonertinib 240 mg oral, daily
furmonertinib tablet
Other Name: AST2818
Experimental: furmonertinib 160 mg Drug: furmonertinib 160 mg oral, daily
furmonertinib tablet
Other Name: AST2818
Active Comparator: platinum-based chemotherapy
carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously
 Drug: platinum-based chemotherapy
(carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) determined by blinded independent central review (BICR) [ Time Frame: Up to 32 months after first dose ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05607550


Contacts
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Contact: Vanessa Esquibel 6195403451 FURMO004CT@arrivent.com

Locations
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Sponsors and Collaborators
ArriVent BioPharma, Inc.
Allist Pharmaceuticals, Inc.
Investigators
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Study Director: Morgan Lam ArriVent BioPharm
More Information
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Responsible Party: ArriVent BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT05607550    
Other Study ID Numbers: FURMO-004
2022-502977-41-00 ( EU Trial (CTIS) Number )
First Posted: November 7, 2022    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ArriVent BioPharma, Inc.:
Non-Small Cell Lung Cancer (NSCLC)
Exon 20
Furmonertinib
Firmonertinib
 AST2818
FURMO-004
Drug-Therapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Aflutinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action