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

NCT07185997 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: FURMO-006
• Study Type: interventional
• Target: 480
• Locations: 15 countries
• Sites: 74

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

Metastatic Non-Small-Cell Lung Cancer; Advanced Non-Small-Cell Lung Cancer; Non-Small-Cell Lung Cancer; EGFR PACC; EGFR Uncommon Mutations; EGFR P-Loop and Alpha C-Helix Compressing

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

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS) determined by blinded independent central review (BICR)

  PFS is defined as the time from randomization to the first occurrence of disease progression as determined by BICR using RECIST v1.1, or death from any cause, whichever occurs first.

  Until progression or death, assessed up to approximately 4 years

• Confirmed overall response rate (ORR) as determined by BICR

  Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR based on BICR assessment relative to the total number of participants.

  Until progression or death, assessed up to approximately 3 years

Secondary Outcomes (7)

• Overall survival (OS)

  Until death, assessed up to approximately 5 years

• Investigator-assessed PFS

  Until progression or death, assessed up to approximately 4 years

• Investigator-assessed confirmed ORR

  Until progression or death, assessed up to approximately 3 years

• Duration of response (DOR)

  Until progression or death, assessed up to approximately 4 years

• Time to second Progression-free survival (PFS2)

  Assessed up to approximately 5 years

Study Arms (2)

Firmonertinib 240 mg

EXPERIMENTAL

Drug: Firmonertinib

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

ACTIVE COMPARATOR

Drug: EGFR-TKI inhibitor based on investigator's choice

Interventions

Firmonertinib DRUG

240 mg oral, daily firmonertinib tablet

Also known as: AST2818

Firmonertinib 240 mg

EGFR-TKI inhibitor based on investigator's choice DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ArriVent BioPharma, Inc.: lead

Study Sites (74)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

RECRUITING

Kaiser Permanente Medical Center

Vallejo, California, 94589, United States

RECRUITING

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

RECRUITING

University of Illinois Hospital and Health Sciences Systems

Chicago, Illinois, 60612, United States

RECRUITING

Northwell Health/R.J. Zuckerberg Cancer Center

Lake Success, New York, 11042, United States

RECRUITING

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Ohio State University Hospitals

Columbus, Ohio, 43210, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Texas Oncology

Dallas, Texas, 75246, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Shenandoah Oncology, P.C.

Winchester, Virginia, 22601, United States

RECRUITING

Swedish Cancer Institute

Edmonds, Washington, 98026, United States

RECRUITING

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, 2148, Australia

RECRUITING

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

RECRUITING

GenesisCare North Shore Health Hub

St Leonards, New South Wales, 2065, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

Alberta Health Services, Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

RECRUITING

BC Cancer Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Centre - University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Hospices Civil de Lyon

Bron, Auvergne-Rhône-Alpes, 69500, France

RECRUITING

Hospital Nord de Marseille

Marseille, Bouches-du-Rhone, 13915, France

RECRUITING

Centre Francois Baclesse

Caen, Calvados, 14076, France

RECRUITING

Hopital Larrey

Toulouse, Occitanie, 31059, France

RECRUITING

Centre Leon-Berard

Lyon, 69373, France

RECRUITING

Insitut de Canderologie d I'Ouest

Saint-Herblain, 44805, France

RECRUITING

Henry Dunant Hospital Center

Athens, 115 26, Greece

RECRUITING

University General Hospital Attikon - General Hospital of West Attica H AGIA VARVARA

Athens, 124 62, Greece

RECRUITING

Athens Medical Center S.A., European Interbalkan Medical Center

Thessaloniki, 570 01, Greece

RECRUITING

Thoracic General Hospital of Athens I Sotiria

Thessaloniki, 570 01, Greece

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong, 000000, Hong Kong

RECRUITING

Humanity and Health Clinical Trial Centre

Central, Hong Kong

RECRUITING

SOC Oncologia Medica e dei Tumori Immuno-correlati

Aviano, 33081, Italy

RECRUITING

Istituto Europeo di Oncologia (IEO)

Milan, 20141, Italy

RECRUITING

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

Kurume University Hospital

Kurume-Shi, Fukuoka, 830-0011, Japan

RECRUITING

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

RECRUITING

Hyogo Cancer Center

Akashi-shi, Hyōgo, 673-8558, Japan

RECRUITING

Miyagi Cancer Center

Natori-shi, Miyagi, 981-1293, Japan

RECRUITING

Niigata Cancer Center Hospital

Niigata, Niigata, 951-8566, Japan

RECRUITING

Kansai Medical University Hospital

Hirakata-shi, Osaka, 573-1191, Japan

RECRUITING

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, 113-8603, Japan

RECRUITING

Tokyo Metropolitan Komagome Hospital

Bunkyō-Ku, Tokyo, 113-8677, Japan

RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

OncoCar Cancer Centre

Petaling Jaya, Selangor, 47810, Malaysia

RECRUITING

Hospital Kuala Lumpur

Kuala Lumpur, WP Kuala Lumpur, 50586, Malaysia

RECRUITING

National Cancer Centre Singapore

Singapore, 168583, Singapore

RECRUITING

Curie Oncology (Farrer)

Singapore, 217562, Singapore

RECRUITING

Tan Tok Seng Hospital

Singapore, 308433, Singapore

RECRUITING

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, 21565, South Korea

RECRUITING

Kyung Hee University Hospital

Seoul, 02447, South Korea

RECRUITING

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Hospital Universitari Son Espases

Palma, Balearic Islands, 07120, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital QuironSalud Malaga

Málaga, 29004, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

RECRUITING

Hospital Universitario y Politecnico La Fe

Valencia, 46026, Spain

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Mahidol University - Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Prince of Songkla Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

University College London Hospitals NHS Foundation Trust

London, England, NW1 2PG, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, England, M20 4BX, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Bronchial Neoplasms; Lung Neoplasms

Interventions

aflutinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases

Study Officials

• Morgan Lam

  ArriVent BioPharm

  STUDY DIRECTOR

Central Study Contacts

Vanessa Esquibel

CONTACT

619-540-3451; FURMO006CT@arrivent.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 22, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

HK (2); MY (2); AU (4); TW (3); ES (5); US (16); SG (3); KR (7); GB (3); CA (5); GR (4); IT (2); JP (10); FR (6); TH (2)