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

Part of paid clinical trials in Prescott, Arizona.

Sponsor
ArriVent BioPharma, Inc.
Study ID
NCT05364073
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Non-Small Cell Lung Cancer
  • EGFR Exon 20 Mutations
  • EGFR Uncommon Mutations, Including G719X and S768I
  • HER2 Exon 20 Mutations
  • Metastatic Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Jun 30, 2022
Status verified
Mar 2026
Primary completion
Jun 3, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
160 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Stage 1 Dose Escalation and Backfill
    Experimental: Previously treated patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations
  • Experimental: Stage 2 Expansion Cohort 1
    Previously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations
  • Experimental: Stage 2 Expansion Cohort 2
    Previously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations
  • Experimental: Stage 2 Expansion Cohort 3
    Previously treated NSCLC Patients with EGFR Activating Mutations, who are not eligible for Cohorts 1 and 4
  • 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

Primary Outcome Measure

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 ]

Locations (7)

FacilityCityStateZIPSite coordinators
ArriVent Investigative SitePrescottArizona86301-
ArriVent Investigative SiteSacramentoCalifornia95817-
ArriVent Investigative SiteWhittierCalifornia90603-
ArriVent Investigative SiteCelebrationFlorida34747-
ArriVent Investigative SiteDetroitMichigan48202-
ArriVent Investigative SiteHoustonTexas77030-
ArriVent Investigative SiteFairfaxVirginia22031-

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ArriVent Investigative Site· Prescott, AZArriVent Investigative Site· Sacramento, CAArriVent Investigative Site· Whittier, CAArriVent Investigative Site· Celebration, FLArriVent Investigative Site· Detroit, MIArriVent Investigative Site· Houston, TX

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