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Study of Furmonertinib in Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations

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ClinicalTrials.gov Identifier: NCT05364073
Recruitment Status : Recruiting
First Posted : May 6, 2022
Last Update Posted : March 8, 2023
Sponsor:
Information provided by (Responsible Party):
ArriVent BioPharma, Inc.

Study Description
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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 (Stage IV) non-small cell lung cancer (NSCLC) with activating Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) mutations. Patients will be enrolled into one of 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 (NSCLC) 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 Metastatic Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer Lung Carcinoma Lung Tumors Carcinoma of the Lung Neoplasm of Lung Cancer of the Lung CARCINOMA OF LUNG Pulmonary Neoplasm Cancer of Lung Pulmonary Cancer Cancers Lungs Lung Malignancies Tumor of the Lung Lung Malignant Tumors Neoplasm of the Lung Pulmonary Carcinoma Pulmonary Neoplasia Human Epidermal Growth Factor Receptor EGF Receptor Stage IV Drug: Furmonertinib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 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 (Stage IV) Non-Small Cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) 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

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Stage 1 Dose Escalation and Backfill
Experimental: Stage 1 Dose Escalation and Backfill Previously treated patients with advanced or metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) with activating Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) mutations
 Drug: Furmonertinib
Furmonertinib tablet
Other Name: AST2818
Experimental: Stage 2 Expansion Cohort 1
Previously Treated Non-Small Cell Lung Cancer (NSCLC) Patients with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations
 Drug: Furmonertinib
Furmonertinib tablet
Other Name: AST2818
Experimental: Stage 2 Expansion Cohort 2
Previously treated Non-Small Cell Lung Cancer (NSCLC) Patients with Human Epidermal Growth Factor Receptor 2 (HER2) Exon 20 Insertion Mutations
 Drug: Furmonertinib
Furmonertinib tablet
Other Name: AST2818
Experimental: Stage 2 Expansion Cohort 3
Previously treated Non-Small Cell Lung Cancer (NSCLC) Patients with Epidermal Growth Factor Receptor (EGFR) Activating Mutations
 Drug: Furmonertinib
Furmonertinib tablet
Other Name: AST2818
Experimental: Stage 2 Expansion Cohort 4
Untreated or Previously treated Epidermal Growth Factor Receptor (EGFR)-TKI Naïve Non-Small Cell Lung Cancer (NSCLC) Patients with Epidermal Growth Factor Receptor (EGFR) Uncommon Mutations
 Drug: Furmonertinib
Furmonertinib tablet
Other Name: AST2818


Outcome Measures
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Primary Outcome Measures :
  1. Stage 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 ]
  2. Stage 2: Overall Response Rate (ORR) [ Time Frame: Up to 36 months after first dose ]

Secondary Outcome Measures :
  1. Stage 1: Overall Response Rate [ Time Frame: Up to 36 months after first dose ]
  2. Stage 1: Duration of Response (DOR) [ Time Frame: Up to 36 months after first dose ]
  3. Stage 1: Disease Control Rate [ Time Frame: Up to 36 months after first dose ]
  4. Stage 1: Progression Free Survival [ Time Frame: Up to 36 months after first dose ]
  5. Stage 1: Depth of Response [ Time Frame: Up to 36 months after first dose ]
  6. Stage 1: Overall survival [ Time Frame: Up to 36 months after first dose ]
  7. Stage 1: Central Nervous System ORR [ Time Frame: Up to 36 months after first dose ]
  8. Stage 1: Central Nervous System DOR [ Time Frame: Up to 36 months after first dose ]
  9. Stage 1: Plasma concentrations of furmonertinib and its major metabolite (AST5902) [ Time Frame: Up to 36 months after first dose ]
  10. Stage 1, Cohort 1, Backfill only: Plasma concentrations of furmonertinib and its major metabolite (AST5902) [ Time Frame: Up to 36 months after first dose ]
  11. Stage 1, Cohort 1, Backfill only: Plasma concentrations of midazolam and its metabolite (1-OH-midazolam) [ Time Frame: Up to 36 months after first dose ]
  12. Stage 2, all cohorts: Duration of Response [ Time Frame: Up to 36 months after first dose ]
  13. Stage 2, all cohorts: Disease Control Rate [ Time Frame: Up to 36 months after first dose ]
  14. Stage 2, all cohorts: Progression Free Survival [ Time Frame: Up to 36 months after first dose ]
  15. Stage 2, all cohorts: Depth of Response [ Time Frame: Up to 36 months after first dose ]
  16. Stage 2, all cohorts: Overall survival [ Time Frame: Up to 36 months after first dose ]
  17. Stage 2, all cohorts: Central Nervous System ORR [ Time Frame: Up to 36 months after first dose ]
  18. Stage 2, all cohorts: Central Nervous System DOR [ Time Frame: Up to 36 months after first dose ]
  19. Stage 2, Cohort 4 only: Overall Response Rate [ Time Frame: Up to 36 months after first dose ]
  20. Stage 2, all cohorts: Number of incidence and severity of AEs as a measure of safety and tolerability of Furmonertinib [ Time Frame: Up to 36 months after first dose ]
  21. Stage 2, all cohorts: 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 (Stage III) or metastatic (Stage IV) Non-Small Cell Lung Cancer (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.
  • Documented radiologic disease progression during or after the last systemic anti-cancer therapy before the first dose of furmonertinib.
  • For patients with Epidermal Growth Factor Receptor (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 and Stage 2 Cohorts 1, 2, 3 and 4:

  • Patients with CNS metastases (including leptomeningeal disease) may be eligible if meeting additional protocol specified criteria.

Stage 1 Dose Escalation and Backfill Cohorts Inclusion Criteria:

- Documented validated results from local testing of tumor tissue or blood confirming the presence of an Epidermal Growth Factor Receptor (EGFR) Exon 20 insertion mutation, Human Epidermal Growth Factor Receptor 2 (HER2) Exon 20 insertion mutation, or Epidermal Growth Factor Receptor (EGFR) activating mutation, performed at a CLIA- or equivalently certified laboratory.

Stage 2 Cohort 1 (Previously Treated, Locally Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) Patients with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations) Inclusion Criteria

  • Documented validated results from local testing of either tumor tissue or blood confirming the presence of Epidermal Growth Factor Receptor (EGFR) Exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory.
  • The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.

Stage 2 Cohort 2 (Previously treated, Locally Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) Patients with Human Epidermal Growth Factor Receptor 2 (HER2) Exon 20 Insertion Mutations) Inclusion Criteria - Documented validated results from local testing of either tumor tissue or blood confirming the presence of Human Epidermal Growth Factor Receptor 2 (HER2) Exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory.

  • The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.
  • In regions in which fam-trastuzumab deruxtecan-nxki is approved and available for adult patients with unresectable or metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) whose tumors have activating Human Epidermal Growth Factor Receptor 2 (HER2) exon 20 mutations, the patient must have received or be considered not appropriate to receive fam-trastuzumab deruxtecan-nxki.

Stage 2 Cohort 3 (Previously Treated, Locally Advanced (Stage III) or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) Patients with Epidermal Growth Factor Receptor (EGFR) Activating Mutations Excluding Exon 20 Insertion Mutations and Uncommon Mutations) Inclusion Criteria

  • Documented validated results from local testing of either tumor tissue or blood confirming the presence of an Epidermal Growth Factor Receptor (EGFR) activating mutation, performed at a CLIA- or equivalently certified laboratory.
  • The patient must have experienced disease progression or have intolerance to treatment with the standard of care Epidermal Growth Factor Receptor (EGFR) TKI.
  • Patients with CNS metastases may be eligible if meeting additional protocol specified criteria.

Stage 2, Cohort 4 (Untreated or Previously Treated Epidermal Growth Factor Receptor (EGFR)-TKI-Naïve, Locally Advanced (Stage III) or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) Patients with Epidermal Growth Factor Receptor (EGFR) Uncommon Mutations) Inclusion Criteria

• Previously untreated in the locally advanced (Stage III) or metastatic (Stage IV) setting or have progressed after at least 1 available standard therapy, or for whom standard therapy has proven to be ineffective, intolerable, or considered inappropriate

• Documented validated results from local testing of either tumor tissue or blood confirming the presence of an Epidermal Growth Factor Receptor (EGFR) Uncommon or Rare mutation, performed at a CLIA- or equivalently certified laboratory

  1. Representative mutations include, but are not limited to, G719X, S768I, E709X , G779F, L747X, V774M, E709_T710delinsD, R776C/H, G724S, E736K, I740_K745dup, N771G, K757M/R, V769L/M, T854X, T751_I759delinsN

    Key Exclusion Criteria:

    - Treatment with chemotherapy, targeted therapy, biologic therapy or an investigational agent as anti-cancer therapy within 3 or 3 elimination 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 bone metastases within 2 weeks prior to initiation of furmonertinib.
    • AE from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia or Grade ≤ 2 peripheral neuropathy.

    Stage 2, Cohort 4 (Untreated or Previously Treated Epidermal Growth Factor Receptor (EGFR)-TKI-Naïve, Locally Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) Patients with Epidermal Growth Factor Receptor (EGFR) Uncommon Mutations) Exclusion Criteria • Prior treatment with any Epidermal Growth Factor Receptor (EGFR)-TKIs • Progression during neoadjuvant or adjuvant therapy (e.g., chemotherapy, radiotherapy, immunotherapy or investigational agents) or within 12 months of completion of above therapies.

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): 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 Withdrawn
Glendale, California, United States, 91204
ArriVent Investigative Site 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 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 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         
Canada
Arrivent Investigative Site Not yet recruiting
Edmonton, Canada, T6G 2R3
Contact: FURMO002CT@arrivent.com         
Arrivent Investigative Site Not yet recruiting
Toronto, Canada, M5G 2M9
Contact: FURMO002CT@arrivent.com         
France
Arrivent Investigative Site Not yet recruiting
Toulouse, France, 31059
Contact: FURMO002CT@arrivent.com         
Arrivent Investigative Site Not yet recruiting
Villejuif, France, 94800
Contact: FURMO002CT@arrivent.com         
Italy
Arrivent Investigative Site Not yet recruiting
Milano, Italy, 20141
Contact: FURMO002CT@arrivent.com         
Japan
ArriVent Investigative Site Recruiting
Chiba-Shi, Japan, 260-0013
Contact: FURMO002CT@arrivent.com         
Arrivent Investigative Site Not yet recruiting
Osaka, Japan, 589-8511
Contact: FURMO002CT@arrivent.com         
Arrivent Investigative Site Recruiting
Tokyo, Japan, 104-0045
Contact: FURMO002CT@arrivent.com         
Arrivent Investigative Site Recruiting
Tokyo, Japan, 135-8550
Contact: FURMO002CT@arrivent.com         
Korea, Republic of
Arrivent Investigative Site Not yet recruiting
Gwangju, Korea, Republic of, 61469
Contact: FURMO002CT@arrivent.com         
Arrivent Investigative Site Not yet recruiting
Seoul, Korea, Republic of, 2447
Contact: FURMO002CT@arrivent.com         
Mexico
Arrivent Investigative Site Not yet recruiting
Ciudad de mexico, Mexico, 14080
Contact: FURMO002CT@arrivent.com         
Netherlands
Arrivent Investigative Site Not yet recruiting
Amsterdam, Netherlands, 1066
Spain
ArriVent Investigative Site Recruiting
Madrid, Spain, 28033
Contact: FURMO002CT@arrivent.com         
ArriVent Investigative Site Recruiting
Madrid, Spain, 28050
Contact: FURMO002CT@arrivent.com         
ArriVent Investigative Site Recruiting
Valencia, Spain, 46026
Contact: FURMO002CT@arrivent.com         
United Kingdom
ArriVent Investigative Site 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
More Information
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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: March 8, 2023
Last Verified: March 2023
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.:
non-small cell lung cancer (NSCLC)
Metastatic Non-Small Cell Lung Cancer
Advanced Non-Small Cell Lung Cancer
EGFR
HER2
Exon 20 Insertion Mutations
HER2 kinase domain mutations
Epidermal Growth Factor Receptor (EGFR) kinase domain mutations
Exon 20
Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations
HER2 Exon 20 Insertion Mutations
Tyrosine Kinase Inhibitor (TKI)
Epidermal Growth Factor Receptor (EGFR) uncommon mutations
Epidermal Growth Factor Receptor (EGFR) atypical mutations
Epidermal Growth Factor Receptor (EGFR) rare mutations
 Human Epidermal Growth Factor Receptor 2 (HER2)
Epidermal Growth Factor Receptor (EGFR)
E709_T710del insD
G779F
L747X
V774M
G719X
S768I
E709X
R776C/H
G724S
E736K
I740_K745dup
N771G
K757M/R
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Lung 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