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

First listed
May 6, 2022
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-

Find similar trials in Prescott, AZ

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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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