This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

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

Layout table for study information
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

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)




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

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
Layout table for location contacts
Contact: Vanessa Esquibel 6195403451 FURMO004CT@arrivent.com

Locations
Show Show 192 study locations
Sponsors and Collaborators
ArriVent BioPharma, Inc.
Allist Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Study Director: Morgan Lam ArriVent BioPharm
Layout table for additonal information
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

Layout table for additional information
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:
Layout table for MeSH terms
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