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RecruitingPHASE3INTERVENTIONAL

Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
ArriVent BioPharma, Inc.
Enrolment target
480
Start
17 Dec 2025
Estimated completion
01 Dec 2030
Non-Small-Cell Lung CancerMetastatic Non-Small-Cell Lung CancerAdvanced Non-Small-Cell Lung CancerEGFR P-Loop and Alpha C-Helix CompressingEGFR PACCEGFR Uncommon Mutations

What is this study about?

Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.

Who may be eligible?

Age 18 Years to any · Sex: ALL

Locations (62)

  • USC/Norris Comprehensive Cancer Center
    Los Angeles, United States· Recruiting
  • University of California Davis Comprehensive Cancer Center
    Sacramento, United States· Recruiting
  • UCSF Medical Center-Mission Bay
    San Francisco, United States· Recruiting
  • Kaiser Permanente Medical Center
    Vallejo, United States· Recruiting
  • Illinois Cancer Specialists
    Arlington Heights, United States· Recruiting
  • University of Illinois Hospital and Health Sciences Systems
    Chicago, United States· Recruiting
  • Northwell Health/R.J. Zuckerberg Cancer Center
    Lake Success, United States· Recruiting
  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
    New York, United States· Recruiting
  • Ohio State University Hospitals
    Columbus, United States· Recruiting
  • Fox Chase Cancer Center
    Philadelphia, United States· Recruiting
  • Texas Oncology
    Dallas, United States· Recruiting
  • The University of Texas MD Anderson Cancer Center
    Houston, United States· Recruiting

+50 more sites — see the official record for the full list.

How to find out more

Vanessa Esquibel

FURMO006CT@arrivent.com 619-540-3451 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study to Evaluate Efficacy and Safety of Firmonertinib Compa…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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