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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-03-13

No results posted yet for this 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).

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

Interventions

DRUG

Furmonertinib

Furmonertinib tablet

DRUG

Furmonertinib

Furmonertinib tablet

DRUG

Furmonertinib

Furmonertinib tablet

DRUG

Furmonertinib

Furmonertinib tablet

DRUG

Furmonertinib

Furmonertinib tablet

Sponsors & Collaborators

  • ArriVent BioPharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Jamuna Thimmarayappa · ArriVent BioPharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2025-06-03
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • France
  • Italy
  • Japan
  • Netherlands
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05364073 on ClinicalTrials.gov