🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT05364073
Active, not recruiting Phase 1

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

NCT05364073 · tracked via the Priya Life Science UK tracker
Sponsor
ArriVent BioPharma, Inc.
Phase
Phase 1
Started
2022-06-30
Last updated
2026-03-13

Condition(s) studied

Non-Small Cell Lung Cancer (NSCLC)Metastatic Non-Small Cell Lung CancerAdvanced Non-Small Cell Lung CancerHER2 Exon 20 MutationsEGFR Exon 20 MutationsEGFR Uncommon Mutations, Including G719X and S768I

Investigational drug(s) / intervention(s)

FurmonertinibFurmonertinibFurmonertinibFurmonertinibFurmonertinib

Furmonertinib: Furmonertinib tablet

Furmonertinib: Furmonertinib tablet

Furmonertinib: Furmonertinib tablet

Furmonertinib: Furmonertinib tablet

Furmonertinib: Furmonertinib tablet

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
ArriVent Investigative Site Prescott Arizona
ArriVent Investigative Site Sacramento California
ArriVent Investigative Site Whittier California
ArriVent Investigative Site Celebration Florida
ArriVent Investigative Site Detroit Michigan
ArriVent Investigative Site Houston Texas
ArriVent Investigative Site Fairfax Virginia
ArriVent Investigative Site Blacktown New South Wales
ArriVent Investigative Site St Leonards New South Wales
ArriVent Investigative Site Heidelberg Victoria
Arrivent Investigative Site Edmonton Canada
Arrivent Investigative Site Toronto Canada
Allist Investigative Site Hefei Anhui
Allist Investigative Site Beijing Beijing Municipality
Allist Investigative Site Chaoyang Beijing Municipality
Allist Investigative Site Chongqing Chongqing Municipality
Allist Investigative Site Harbin Heilongjiang
Allist Investigative Site Zhengzhou Henan
Allist Investigative Site Zhengzhou Henan
Allist Investigative Site Wuhan Hubei
Allist Investigative Site Xuzhou Jiangsu
Allist Investigative Site Nanchang Jianxi
Allist Investigative Site Changchun Jilin
Allist Investigative Site Jinan Shandong
Allist Investigative Site Jinan Shandong
Allist Investigative Site Taiyuan Shanxi
ArriVent Investigative Site Lyon France
Arrivent Investigative Site Toulouse France
Arrivent Investigative Site Villejuif France
ArriVent Investigative Site Medolla Italy
ArriVent Investigative Site Chiba Chiba
Arrivent Investigative Site Ōsaka-sayama Osaka
Arrivent Investigative Site Chūō Tokyo
Arrivent Investigative Site Koto-Ku Tokyo
Arrivent Investigative Site Amsterdam North Holland
Arrivent Investigative Site Gwangju South Korea
Arrivent Investigative Site Seoul South Korea
ArriVent Investigative Site Barcelona Spain
ArriVent Investigative Site Madrid Spain
ArriVent Investigative Site Madrid Spain

+ 2 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05364073 on ClinicalTrials.gov ↗ ← All trials in the UK