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Trial record 1 of 1 for:    NCT05364073
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Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Activating EGFR or HER2 Mutations, Including Exon 20 Insertion Mutations

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ClinicalTrials.gov Identifier: NCT05364073
Recruitment Status : Recruiting
First Posted : May 6, 2022
Last Update Posted : September 1, 2022
Sponsor:
Information provided by (Responsible Party):
ArriVent BioPharma, Inc.

Brief Summary:
This is a Phase 1b, open-label, multi-center, dose-escalation and dose-expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations, including Exon 20 insertion mutations. Patients will be enrolled into 2 stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion).

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 Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Drug: Furmonertinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Antitumor Activity of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Activating EGFR or HER2 Mutations, Including Exon 20 Insertion Mutations
Actual Study Start Date : June 30, 2022
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stage 1 Dose Escalation and Backfill
Previously treated patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations, including Exon 20 insertion mutations
Drug: Furmonertinib
Furmonertinib tablet
Other Name: AST2818

Experimental: Stage 2 Expansion Cohort 1
Previously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations
Drug: Furmonertinib
Furmonertinib tablet
Other Name: AST2818

Experimental: Stage 2 Expansion Cohort 2
Previously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations
Drug: Furmonertinib
Furmonertinib tablet
Other Name: AST2818

Experimental: Stage 2 Expansion Cohort 3
Previously treated NSCLC Patients with EGFR Activating Mutations
Drug: Furmonertinib
Furmonertinib tablet
Other Name: AST2818




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 36 months after first dose ]
  2. Duration of Response (DOR) [ Time Frame: Up to 36 months after first dose ]
  3. Progression Free Survival (PFS) [ Time Frame: Up to 36 months after first dose ]
  4. Overall survival [ Time Frame: Up to 36 months after first dose ]
  5. Central Nervous System (CNS) ORR [ Time Frame: Up to 36 months after first dose ]
  6. Central Nervous System (CNS) DOR [ Time Frame: Up to 36 months after first dose ]


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 NSCLC not amenable to curative surgery or radiotherapy.
  • Disease that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable; or for whom a clinical trial of an investigational agent is a recognized standard of care.
  • Patients with a history of treated CNS metastases or new asymptomatic CNS metastases detected at screening are eligible.
  • Documented radiologic disease progression during or after the last systemic anti-cancer therapy before the first dose of the investigational product (furmonertinib).
  • For patients with EGFR mutations sensitive to osimertinib, the patient must have received osimertinib prior to study enrollment in regions where osimertinib is approved, including the US.

Stage 1 Dose Escalation and Backfill Cohorts Inclusion Criteria:

  • Documented validated results from local testing of blood or tumor tissue confirming the presence of an EGFR Exon 20 insertion mutation, HER2 Exon 20 insertion mutation, or EGFR activating mutation.
  • For patients with NSCLC with EGFR Exon 20 insertion mutations or HER2 Exon 20 insertion mutations, the patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.
  • For patients with NSCLC with EGFR activating mutations other than Exon 20 insertion mutations, the patient must have experienced disease progression with the standard of care EGFR TKI.

Stage 2 Cohort 1 (Previously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations) Inclusion Criteria

  • Documented validated results from either local testing of blood or tumor tissue confirming the presence of EGFR Exon 20 insertion mutations.
  • The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.

Stage 2 Cohort 2 (Previously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations) Inclusion Criteria

  • Documented validated results from either local testing of blood or tumor tissue confirming the presence of HER2 Exon 20 insertion mutations.
  • The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.

Stage 2 Cohort 3 (Previously Treated NSCLC Patients with EGFR Activating Mutations and Excluding Exon 20 Insertion Mutations) Inclusion Criteria

  • Documented validated results from either local testing of blood or tumor tissue confirming the presence of an EGFR activating mutation.
  • The patient must have experienced disease progression or have intolerance to treatment with the standard of care EGFR TKI.

Key Exclusion Criteria:

  • Treatment with chemotherapy, immunotherapy, biologic therapy or an investigational agent as anti-cancer therapy within 3 weeks or five half-lives prior to initiation of furmonertinib, whichever is shorter, or endocrine therapy within 2 weeks prior to initiation of furmonertinib.
  • Radiation therapy as cancer therapy within 4 weeks prior to initiation of furmonertinib.
  • Palliative radiation to bony metastases within 2 weeks prior to initiation of furmonertinib.
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia or Grade ≤ 2 peripheral neuropathy.

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): NCT05364073


Contacts
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Contact: Nichole Baio 628-277-4836 FURMO002CT@arrivent.com

Locations
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United States, California
ArriVent Investigative Site Recruiting
Glendale, California, United States, 91204
Contact: FURMO002CT@arrivent.com         
ArriVent Investigative Site Not yet recruiting
Sacramento, California, United States, 95817
Contact       FURMO002CT@arrivent.com   
United States, Florida
ArriVent Investigative Site Not yet recruiting
Orlando, Florida, United States, 32804
Contact       FURMO002CT@arrivent.com   
United States, Kansas
ArriVent Investigative Site Not yet recruiting
Westwood, Kansas, United States, 66205
Contact       FURMO002CT@arrivent.com   
United States, Michigan
ArriVent Investigative Site Not yet recruiting
Detroit, Michigan, United States, 48202
Contact       FURMO002CT@arrivent.com   
United States, Virginia
ArriVent Investigative Site Recruiting
Fairfax, Virginia, United States, 22031
Contact: Carrie Friedman    703-636-1473    Carrie.Friedman@usoncology.com   
Australia, New South Wales
ArriVent Investigative Site Not yet recruiting
Blacktown, New South Wales, Australia, 2148
Contact: FURMO002CT@arrivent.com         
Australia, Victoria
ArriVent Investigative Site Not yet recruiting
Heidelberg, Victoria, Australia, 3084
Contact: FURMO002CT@arrivent.com         
Japan
ArriVent Investigative Site Not yet recruiting
Chiba-Shi, Japan, 260-0013
Contact: FURMO002CT@arrivent.com         
Spain
ArriVent Investigative Site Not yet recruiting
Madrid, Spain, 28033
Contact: FURMO002CT@arrivent.com         
ArriVent Investigative Site Not yet recruiting
Madrid, Spain, 28050
Contact: FURMO002CT@arrivent.com         
ArriVent Investigative Site Not yet recruiting
Valencia, Spain, 46026
Contact: FURMO002CT@arrivent.com         
United Kingdom
ArriVent Investigative Site Not yet recruiting
London, United Kingdom, NW12PG
Contact: FURMO002CT@arrivent.com         
Sponsors and Collaborators
ArriVent BioPharma, Inc.
Investigators
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Study Director: Morgan Lam ArriVent BioPharma
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Responsible Party: ArriVent BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT05364073    
Other Study ID Numbers: FURMO-002
First Posted: May 6, 2022    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
HER2
Exon 20 Insertion Mutations
HER2 kinase domain mutations
EGFR kinase domain mutations
Exon 20
EGFR Exon 20 Insertion Mutations
HER2 Exon 20 Insertion Mutations
Tyrosine Kinase Inhibitor (TKI)
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Thoracic Neoplasms
Respiratory Tract Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bronchial Diseases
Aflutinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action