> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-furmonertinib-in-patients-with-advanced-or-8d0b9997-1936-4c6d-9611-d28f93d0a7f4 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) Lead sponsor ArriVent BioPharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) Start date 2022-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) Number of sites 42 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) ## Dates **Completion date** 2026-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **First posted** 2022-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Registry last updated** 2026-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Primary completion date** 2025-06-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Start date** 2022-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) ## Size and sites **Actual participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Number of sites** 42 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Lead sponsor** ArriVent BioPharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) ## Identifiers **Registry ID** NCT05364073 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **ClinicalTrials.gov ID** NCT05364073 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) ## Outcomes ### Primary outcomes 1. Stage 1: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib Timeframe: Up to 36 months after first dose 2. Stage 2: Overall Response Rate (ORR) Timeframe: Up to 36 months after first dose ### Secondary outcomes 1. Stage 1: Overall Response Rate Timeframe: Up to 36 months after first dose 2. Stage 1: Duration of Response (DOR) Timeframe: Up to 36 months after first dose 3. Stage 1: Disease Control Rate Timeframe: Up to 36 months after first dose 4. Stage 1: Progression Free Survival Timeframe: Up to 36 months after first dose 5. Stage 1: Depth of Response Timeframe: Up to 36 months after first dose 6. Stage 1: Overall survival Timeframe: Up to 36 months after first dose 7. Stage 1: Central Nervous System ORR Timeframe: Up to 36 months after first dose 8. Stage 1: Central Nervous System DOR Timeframe: Up to 36 months after first dose 9. Stage 1: Plasma concentrations of furmonertinib and its major metabolite (AST5902) Timeframe: Up to 36 months after first dose 10. Stage 1, Cohort 1, Backfill only: Plasma concentrations of furmonertinib and its major metabolite (AST5902) Timeframe: Up to 36 months after first dose 11. Stage 1, Cohort 1, Backfill only: Plasma concentrations of midazolam and its metabolite (1-OH-midazolam) Timeframe: Up to 36 months after first dose 12. Stage 2, all cohorts: Duration of Response Timeframe: Up to 36 months after first dose 13. Stage 2, all cohorts: Disease Control Rate Timeframe: Up to 36 months after first dose 14. Stage 2, all cohorts: Progression Free Survival Timeframe: Up to 36 months after first dose 15. Stage 2, all cohorts: Depth of Response Timeframe: Up to 36 months after first dose 16. Stage 2, all cohorts: Overall survival Timeframe: Up to 36 months after first dose 17. Stage 2, all cohorts: Central Nervous System ORR Timeframe: Up to 36 months after first dose 18. Stage 2, all cohorts: Central Nervous System DOR Timeframe: Up to 36 months after first dose 19. Stage 2, Cohort 4 only: Overall Response Rate Timeframe: 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 Timeframe: Up to 36 months after first dose 21. Stage 2, all cohorts: Plasma concentrations of furmonertinib and its major metabolite (AST5902) Timeframe: Up to 36 months after first dose Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) ## Sites - ArriVent Investigative SitePrescott, United States - ArriVent Investigative SiteSacramento, United States - ArriVent Investigative SiteWhittier, United States - ArriVent Investigative SiteCelebration, United States - ArriVent Investigative SiteDetroit, United States - ArriVent Investigative SiteHouston, United States - ArriVent Investigative SiteFairfax, United States - ArriVent Investigative SiteBlacktown, Australia - ArriVent Investigative SiteSt Leonards, Australia - ArriVent Investigative SiteHeidelberg, Australia - Arrivent Investigative SiteEdmonton, Canada - Arrivent Investigative SiteToronto, Canada - Allist Investigative SiteHefei, China - Allist Investigative SiteBeijing, China - Allist Investigative SiteChaoyang, China - Allist Investigative SiteChongqing, China - Allist Investigative SiteHarbin, China - Allist Investigative SiteZhengzhou, China - Allist Investigative SiteZhengzhou, China - Allist Investigative SiteWuhan, China - Allist Investigative SiteXuzhou, China - Allist Investigative SiteNanchang, China - Allist Investigative SiteChangchun, China - Allist Investigative SiteJinan, China - Allist Investigative SiteJinan, China And 17 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05364073) ## Related records ### Drugs (1) - [Firmonertinib](https://trialight.com/data/asset/firmonertinib-1107bf98-5b0b-42bc-a524-ed82fe088880.md) ### Lead sponsors (1) - [ArriVent BioPharma, Inc.](https://trialight.com/data/company/arrivent-biopharma-inc-a1c62122-e234-44d3-9bc1-ccfabc57145a.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (1) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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