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Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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 : December 16, 2022
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 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 NSCLC with 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
Non-Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Drug: furmonertinib 240 mg Drug: furmonertinib 160 mg 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 With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations
Estimated Study Start Date : December 15, 2022
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
furmonertinib tablet
 Drug: furmonertinib 240 mg
furmonertinib tablet
Other Name: AST2818
Experimental: furmonertinib 160 mg
furmonertinib tablet
 Drug: furmonertinib 160 mg
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

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.


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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 NSCLC not amenable to curative surgery or radiotherapy.
  • Documented validated results confirming the presence of an 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 NSCLC including prior treatment with any 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 chemoradiotherapy for non-metastatic disease 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: Iva VanDenAkker 628-277-4836 FURMO004CT@arrivent.com

Locations
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United States, Arizona
Arrivent Investigative Site Recruiting
Yuma, Arizona, United States, 85364
Contact: FURMO004CT@arrivent.com         
United States, Arkansas
Arrivent Investigative Site Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: FURMO004CT@arrivent.com         
United States, California
Arrivent Investigative Site Not yet recruiting
Fullerton, California, United States, 92835
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Recruiting
Long Beach, California, United States, 90806
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Not yet recruiting
Napa, California, United States, 94558
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Recruiting
San Diego, California, United States, 92123
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Recruiting
Santa Barbara, California, United States, 93105
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Not yet recruiting
Santa Rosa, California, United States, 95403
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Not yet recruiting
Whittier, California, United States, 90602
Contact: FURMO004CT@arrivent.com         
United States, Connecticut
Arrivent Investigative Site Not yet recruiting
Hartford, Connecticut, United States, 06102
Contact: FURMO004CT@arrivent.com         
United States, Florida
Arrivent Investigative Site Not yet recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Recruiting
Ocala, Florida, United States, 34474
Contact: FURMO004CT@arrivent.com         
United States, Illinois
Arrivent Investigative Site Not yet recruiting
Peoria, Illinois, United States, 61615
Contact: FURMO004CT@arrivent.com         
United States, Indiana
Arrivent Investigative Site Not yet recruiting
Indianapolis, Indiana, United States, 46250
Contact: FURMO004CT@arrivent.com         
United States, Maryland
Arrivent Investigative Site Not yet recruiting
Bethesda, Maryland, United States, 20817
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Not yet recruiting
Frederick, Maryland, United States, 21702
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Not yet recruiting
Rockville, Maryland, United States, 20850
Contact: FURMO004CT@arrivent.com         
United States, Massachusetts
Arrivent Investigative Site Not yet recruiting
Fairhaven, Massachusetts, United States, 02719
Contact: FURMO004CT@arrivent.com         
United States, Michigan
Arrivent Investigative Site Recruiting
Lansing, Michigan, United States, 48912
Contact: FURMO004CT@arrivent.com         
United States, Missouri
Arrivent Investigative Site Recruiting
Bolivar, Missouri, United States, 65613
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Recruiting
Saint Joseph, Missouri, United States, 64507
Contact: FURMO004CT@arrivent.com         
United States, Nebraska
Arrivent Investigative Site Recruiting
Omaha, Nebraska, United States, 68130
Contact: FURMO004CT@arrivent.com         
United States, New Jersey
Arrivent Investigative Site Recruiting
Englewood, New Jersey, United States, 07631
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Not yet recruiting
Florham Park, New Jersey, United States, 07932
Contact: FURMO004CT@arrivent.com         
United States, North Carolina
Arrivent Investigative Site Not yet recruiting
Goldsboro, North Carolina, United States, 27534
Contact: FURMO004CT@arrivent.com         
United States, Ohio
Arrivent Investigative Site Not yet recruiting
Cincinnati, Ohio, United States, 45220
Contact: FURMO004CT@arrivent.com         
United States, Oklahoma
Arrivent Investigative Site Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: FURMO004CT@arrivent.com         
United States, Oregon
Arrivent Investigative Site Recruiting
Salem, Oregon, United States, 97301
Contact: FURMO004CT@arrivent.com         
United States, Pennsylvania
Arrivent Investigative Site Not yet recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: FURMO004CT@arrivent.com         
United States, South Carolina
Arrivent Investigative Site Recruiting
Greenville, South Carolina, United States, 29607
Contact: FURMO004CT@arrivent.com         
United States, South Dakota
Arrivent Investigative Site Recruiting
Sioux Falls, South Dakota, United States, 57117
Contact: FURMO004CT@arrivent.com         
United States, Tennessee
ArriVent Investigative Site Recruiting
Memphis, Tennessee, United States, 38120
Contact: ArriVent I FURMO004CT@arrivent.com         
United States, Texas
Arrivent Investigative Site Recruiting
Dallas, Texas, United States, 75230
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Recruiting
Houston, Texas, United States, 77030
Contact: FURMO004CT@arrivent.com         
United States, Utah
Arrivent Investigative Site Not yet recruiting
Ogden, Utah, United States, 84405
Contact: FURMO004CT@arrivent.com         
Arrivent Investigative Site Recruiting
Salt Lake City, Utah, United States, 84106
Contact: FURMO004CT@arrivent.com         
United States, Virginia
ArriVent Investigative Site Not yet recruiting
Fairfax, Virginia, United States, 22031
Contact: FURMO004CT@arrivent.com         
United States, Washington
Arrivent Investigative Site Recruiting
Tacoma, Washington, United States, 98405
Contact: FURMO004CT@arrivent.com         
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
First Posted: November 7, 2022    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 2022
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.:
NSCLC
Metastatic Non-Small Cell Lung Cancer
Advanced Non-Small Cell Lung Cancer
EGFR
Exon 20 Insertion Mutations
EGFR kinase domain mutations
Exon 20
EGFR Exon 20 Insertion Mutations
 Tyrosine Kinase Inhibitor (TKI)
Platinum-based chemotherapy
Chemotherapy
Cisplatin
Carboplatin
Pemetrexed
Furmonertinib
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Respiratory Tract Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
 Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Thoracic Neoplasms
Bronchial Diseases
Aflutinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action