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

Study 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedFurmonertinib and Furmonertinib

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · HER2

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 13, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?42 U.S. locations

Locations may change over time.

Who runs it?ArriVent BioPharma, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: ArriVent BioPharma, Inc.
Interventions being studied: Drug: Furmonertinib; Drug: Furmonertinib; Drug: Furmonertinib; Drug: Furmonertinib; Drug: Furmonertinib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→Metastatic or stage IV→

Biomarkers

EGFR→HER2→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key
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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

ArriVent Investigative SitePrescott, Arizona
ArriVent Investigative SiteSacramento, California
ArriVent Investigative SiteWhittier, California
ArriVent Investigative SiteCelebration, Florida
ArriVent Investigative SiteDetroit, Michigan
ArriVent Investigative SiteHouston, Texas
ArriVent Investigative SiteFairfax, Virginia
ArriVent Investigative SiteBlacktown, New South Wales
ArriVent Investigative SiteSt Leonards, New South Wales
ArriVent Investigative SiteHeidelberg, Victoria
Arrivent Investigative SiteEdmonton
Arrivent Investigative SiteToronto

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 13, 2026. Always confirm current availability with the study team.

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