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 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: FURMO-002
• Study Type: interventional
• Target: 160
• Locations: 11 countries
• Sites: 42

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).

Conditions

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

Keywords

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; G719A; G719S; R776C; R776H; K757M; K757R; V769L; V769M; osimertinib; afatinib; E709_T710del insD; G779F; L747X

Outcome Measures

Primary Outcomes (2)

• Stage 1: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib

  Up to 36 months after first dose

• Stage 2: Overall Response Rate (ORR)

  Up to 36 months after first dose

Secondary Outcomes (21)

• Stage 1: Overall Response Rate

  Up to 36 months after first dose

• Stage 1: Duration of Response (DOR)

  Up to 36 months after first dose

• Stage 1: Disease Control Rate

  Up to 36 months after first dose

• Stage 1: Progression Free Survival

  Up to 36 months after first dose

• Stage 1: Depth of Response

  Up to 36 months after first dose

Study Arms (5)

Stage 1 Dose Escalation and Backfill

EXPERIMENTAL

Experimental: Previously treated patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations

Drug: Furmonertinib

Stage 2 Expansion Cohort 1

EXPERIMENTAL

Previously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations

Drug: Furmonertinib

Stage 2 Expansion Cohort 2

EXPERIMENTAL

Previously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations

Drug: Furmonertinib

Stage 2 Expansion Cohort 3

EXPERIMENTAL

Previously treated NSCLC Patients with EGFR Activating Mutations, who are not eligible for Cohorts 1 and 4

Drug: Furmonertinib

Stage 2 Expansion Cohort 4

EXPERIMENTAL

Untreated or Previously treated EGFR TKI Naïve NSCLC Patients with EGFR Uncommon Mutations, excluding EGFR exon 20 insertion mutations

Drug: Furmonertinib

Interventions

Furmonertinib DRUG

Furmonertinib tablet

Also known as: AST2818

Stage 1 Dose Escalation and Backfill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \- 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.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ArriVent BioPharma, Inc.: lead

Study Sites (42)

ArriVent Investigative Site

Prescott, Arizona, 86301, United States

Location

ArriVent Investigative Site

Sacramento, California, 95817, United States

Location

ArriVent Investigative Site

Whittier, California, 90603, United States

Location

ArriVent Investigative Site

Celebration, Florida, 34747, United States

Location

ArriVent Investigative Site

Detroit, Michigan, 48202, United States

Location

ArriVent Investigative Site

Houston, Texas, 77030, United States

Location

ArriVent Investigative Site

Fairfax, Virginia, 22031, United States

Location

ArriVent Investigative Site

Blacktown, New South Wales, 2148, Australia

Location

ArriVent Investigative Site

St Leonards, New South Wales, 2065, Australia

Location

ArriVent Investigative Site

Heidelberg, Victoria, 3084, Australia

Location

Arrivent Investigative Site

Edmonton, T6G 1Z2, Canada

Location

Arrivent Investigative Site

Toronto, M5G 2M9, Canada

Location

Allist Investigative Site

Hefei, Anhui, 230001, China

Location

Allist Investigative Site

Beijing, Beijing Municipality, 101119, China

Location

Allist Investigative Site

Chaoyang, Beijing Municipality, 100021, China

Location

Allist Investigative Site

Chongqing, Chongqing Municipality, 400030, China

Location

Allist Investigative Site

Harbin, Heilongjiang, 150081, China

Location

Allist Investigative Site

Zhengzhou, Henan, 450003, China

Location

Allist Investigative Site

Zhengzhou, Henan, 450052, China

Location

Allist Investigative Site

Wuhan, Hubei, 430022, China

Location

Allist Investigative Site

Xuzhou, Jiangsu, 221000, China

Location

Allist Investigative Site

Nanchang, Jianxi, 330008, China

Location

Allist Investigative Site

Changchun, Jilin, 130012, China

Location

Allist Investigative Site

Jinan, Shandong, 250021, China

Location

Allist Investigative Site

Jinan, Shandong, 250117, China

Location

Allist Investigative Site

Taiyuan, Shanxi, 030013, China

Location

ArriVent Investigative Site

Lyon, 69373, France

Location

Arrivent Investigative Site

Toulouse, 31059, France

Location

Arrivent Investigative Site

Villejuif, 94800, France

Location

ArriVent Investigative Site

Medolla, 47014, Italy

Location

ArriVent Investigative Site

Chiba, Chiba, 260-0013, Japan

Location

Arrivent Investigative Site

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Arrivent Investigative Site

Chūō, Tokyo, 104-0045, Japan

Location

Arrivent Investigative Site

Koto-Ku, Tokyo, 135-8550, Japan

Location

Arrivent Investigative Site

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Arrivent Investigative Site

Gwangju, 61469, South Korea

Location

Arrivent Investigative Site

Seoul, 2447, South Korea

Location

ArriVent Investigative Site

Barcelona, 08035, Spain

Location

ArriVent Investigative Site

Madrid, 28033, Spain

Location

ArriVent Investigative Site

Madrid, 28050, Spain

Location

ArriVent Investigative Site

Valencia, 46026, Spain

Location

ArriVent Investigative Site

London, NW12PG, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aflutinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jamuna Thimmarayappa

  ArriVent BioPharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: May 6, 2022
• Study Start: June 30, 2022
• Primary Completion: June 3, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14); JP (4); IT (1); ES (4); CA (2); NL (1); GB (1); US (7); KR (2); AU (3); FR (3)