Recruiting
Phase 3

Firmonertinib vs. Osimertinib, Afatinib

Sponsor:

ArriVent BioPharma, Inc.

Code:

NCT07185997

Conditions

Non-Small-Cell Lung Cancer

Metastatic Non-Small-Cell Lung Cancer

Advanced Non-Small-Cell Lung Cancer

EGFR P-Loop and Alpha C-Helix Compressing

EGFR PACC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Firmonertinib

EGFR-TKI inhibitor based on investigator's choice

Study Details

Brief summary:

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

Non-Small-Cell Lung Cancer

Metastatic Non-Small-Cell Lung Cancer

Advanced Non-Small-Cell Lung Cancer

EGFR P-Loop and Alpha C-Helix Compressing

EGFR PACC

Study ID

NCT07185997

Start date

Dec 17, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Firmonertinib 240 mg

active comparator: EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice

Interventions

Firmonertinib

240 mg oral, daily firmonertinib tablet

EGFR-TKI inhibitor based on investigator's choice

osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet

Primary outcome measure

  • Progression Free Survival (PFS) determined by blinded independent central review (BICR) [ Time Frame: Until progression or death, assessed up to approximately 4 years ]
  • Confirmed overall response rate (ORR) as determined by BICR [ Time Frame: Until progression or death, assessed up to approximately 3 years ]

Central Contacts and Locations

Central contacts

Clinical Trials

(888) 622-2827FURMO006CT@arrivent.com

Locations

St. Jude Medical Center

Recruiting

Fullerton, California, United States, 92835

USC/Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Providence St. Joseph Hospital

Recruiting

Orange, California, United States, 92868

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

UCSF Medical Center-Mission Bay

Recruiting

San Francisco, California, United States, 94158

Kaiser Permanente Medical Center

Recruiting

Vallejo, California, United States, 94589

University of Colorado Health

Recruiting

Aurora, Colorado, United States, 80045

Illinois Cancer Specialists

Recruiting

Arlington Heights, Illinois, United States, 60005

University of Illinois Hospital and Health Sciences Systems

Recruiting

Chicago, Illinois, United States, 60612

Henry Ford Cancer Institute

Recruiting

Detroit, Michigan, United States, 48202

Northwell Health/R.J. Zuckerberg Cancer Center

Recruiting

Lake Success, New York, United States, 11042

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

Recruiting

New York, New York, United States, 10016

Ohio State University Hospitals

Recruiting

Columbus, Ohio, United States, 43210

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Texas Oncology

Recruiting

Dallas, Texas, United States, 75246

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Shenandoah Oncology, P.C.

Recruiting

Winchester, Virginia, United States, 22601

Swedish Cancer Institute

Recruiting

Edmonds, Washington, United States, 98026

Alberta Health Services, Tom Baker Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 4N2

BC Cancer Vancouver Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Brampton Civic Hospital, William Osler Health Centre

Recruiting

Brampton, Ontario, Canada, L6R 3J7

The Ottawa Hospital Cancer Centre

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Sunnybrook Research Institute

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Princess Margaret Cancer Centre - University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

ArriVent BioPharma, Inc.

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Non-Small Cell Lung Cancer (NSCLC)
  • PACC
  • Firmonertinib
  • Furmonertinib
  • AST2818
  • FURMO-006
  • Drug-Therapy
  • Metastatic Non-Small Cell Lung Cancer
  • Advanced Non-Small Cell Lung Cancer
  • NSCLC
  • Osimertinib
  • Afatinib
  • metastatic NSCLC first-line treatment
  • Carcinoma NSCLC
  • Respiratory tract neoplasms
  • Bronchial Neoplasms
  • Protein Kinase Inhibitors
  • tyrosine kinase inhibitor (TKI)
  • Alflutinib
  • Lung neoplasms
  • EGFR
  • EGFR kinase domain mutations
  • EGFR activating mutation
  • EGFR mutation of unknown significance
  • Non-classical EGFR mutation
  • EGFR uncommon mutations
  • EGFR atypical mutations
  • G719X
  • S768I
  • E709X
  • E709_T710delinsD
  • G779F
  • L747X
  • V774M
  • L747P/S
  • R776C/H
  • G724S
  • E736K
  • I740_K745dup
  • N771G
  • K757M/R
  • V769L/M

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ArriVent BioPharma, Inc. on 2026-09-01.