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Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, 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 : February 21, 2024
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 non-small cell lung cancer (NSCLC) with activating, including uncommon, 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) Metastatic Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer HER2 Exon 20 Mutations EGFR Exon 20 Mutations EGFR Uncommon Mutations, Including G719X and S768I Drug: Furmonertinib Phase 1

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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 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
Drug Information available for: Nepidermin

Arm Intervention/treatment
Experimental: Stage 1 Dose Escalation and Backfill
Experimental: Previously treated patients with advanced or metastatic NSCLC with activating EGFR or HER2 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, who are not eligible for Cohorts 1 and 4
Drug: Furmonertinib
Furmonertinib tablet
Other Name: AST2818

Experimental: Stage 2 Expansion Cohort 4
Untreated or Previously treated EGFR TKI Naïve NSCLC Patients with EGFR Uncommon Mutations, excluding EGFR exon 20 insertion mutations
Drug: Furmonertinib
Furmonertinib tablet
Other Name: AST2818




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 ]


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-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 activating, including uncommon, EGFR mutation or HER2 exon 20 insertion mutation performed at a CLIA-or equivalently certified laboratory.

Stage 2 Cohort 1 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR Exon 20 Insertion Mutations Inclusion Criteria

  • Documented validated results from local testing of either tumor tissue or blood confirming the presence of 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 NSCLC Patients with HER2 Exon 20 Insertion Mutations Inclusion Criteria

  • Documented validated results from local testing of either tumor tissue or blood confirming the presence of 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 NSCLC whose tumors have activating 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 or Metastatic NSCLC Patients with EGFR Activating Mutations Mutations, who are not eligible for Cohorts 1 and 4 Inclusion Criteria

  • Documented validated results from local testing of either tumor tissue or blood confirming the presence of an 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 EGFR TKI.
  • Patients with CNS metastases may be eligible if meeting additional protocol specified criteria.

Stage 2 Cohort 4 Untreated or Previously Treated EGFR TKI-Naïve, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations excluding EGFR Exon 20 insertions Inclusion Criteria

  • Previously untreated in the locally advanced or metastatic 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 EGFR Uncommon mutation, performed at a CLIA- or equivalently certified laboratory a. 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 EGFR TKI-Naïve, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations Exclusion Criteria

  • Prior treatment with any 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.

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
Show Show 45 study locations
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: February 21, 2024
Last Verified: February 2024
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)
Human Epidermal Growth Factor Receptor 2 (HER2)
Epidermal Growth Factor Receptor (EGFR)
EGFR uncommon mutations
EGFR atypical mutations
EGFR rare mutations
V774M
G719X
S768I
E709X
R776C/H
G724S
E736K
I740_K745dup
N771G
K757M/R
V769L/M
T854X
T751_I759delinsN
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