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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

Key Eligibility Criteria:

- Histologically or cytologically documented, locally advanced or metastatic Non-Small
Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.

- Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR)
PACC mutation in tumor tissue or blood from local testing.

- No prior systemic anticancer therapy regimens received for locally advanced or
metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any
Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR)
TKIs, monoclonal antibodies, or bispecific antibodies).

- Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy,
immunotherapy, or chemo radiotherapy for non-metastatic disease must have
experienced a treatment free interval of at least 12 months.

- Patients with asymptomatic CNS metastases are eligible.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Firmonertinib 240 mg
  • Drug: Firmonertinib
    240 mg oral, daily firmonertinib tablet
    Other names:
    • AST2818
Active Comparator
EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice
  • Drug: EGFR-TKI inhibitor based on investigator's choice
    osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet

Recruiting Locations

USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033

University of California Davis Comprehensive Cancer Center
Sacramento, California 95817

UCSF Medical Center-Mission Bay
San Francisco, California 94158

Kaiser Permanente Medical Center
Vallejo, California 94589

Illinois Cancer Specialists
Arlington Heights, Illinois 60005

University of Illinois Hospital and Health Sciences Systems
Chicago, Illinois 60612

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016

Texas Oncology
Dallas, Texas 75246

The University of Texas MD Anderson Cancer Center
Houston, Texas 77030

University of Virginia
Charlottesville, Virginia 22903

Virginia Cancer Specialists
Fairfax, Virginia 22031

Shenandoah Oncology, P.C.
Winchester, Virginia 22601

More Details

Status
Recruiting
Sponsor
ArriVent BioPharma, Inc.

Study Contact

Vanessa Esquibel
619-540-3451
FURMO006CT@arrivent.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.