Non-Small-Cell Lung CancerPhase 3NCT07185997
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
A Phase 3 study testing Firmonertinib and EGFR-TKI inhibitor based on investigator's choice in people with Non-Small-Cell Lung Cancer and Metastatic Non-Small-Cell Lung Cancer, run by ArriVent BioPharma, Inc. at 139 sites in 17 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer
- What is being tested?
- Firmonertinib and EGFR-TKI inhibitor based on investigator's choice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 139 sitesin 17 countries
- Study dates
- 17 Dec 2025to Dec 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
- List of eligible PACC mutations:
E709X, E709A, E709H, E709V, E709K E709_T710delinsD, E709_T710delinsA, E709_T710delinsG, L718M, L718P, L718Q, L718V, G719X, G719A, G719C, G719D, G719S, G724S, E736K, I740_K745dup, I740_K745dupIPVAIK, I744_K745insKIPVAI, L747P, L747S, K757M, K757R, V765L, S768I, S768_V769delinsIL, S768_V769delinsIM, S768_V769delinsPL, V769L, V769M, N771G, H773_V774delinsLM, V774M, R776C, R776H, G779F, L792H, G796S, T854A, T854S, T854I, A647T, R675W, S768C, A755D, A750_I759delinsPN, T751_I759delinsN
Trial locations and contacts
139 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
139 sites in 17 countries
China46 sites, 46 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
- Recruiting
Peking University Cancer Hospital (PKUCH)/Beijing Cancer Hospital
Beijing, Beijing Municipality, 101142
- Recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
- Recruiting
Profile of The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610213
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 611135
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400020
- Recruiting
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
- Recruiting
The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230036
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010030
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
- Recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276001
- Recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 47100
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210031
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530012
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 276001
- Recruiting
Shanghai Geriatric Medical Center
Shanghai, Shanghai Municipality, 200000
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 20030
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515000
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
- Recruiting
Cancer hospital of Dalian university of technology
Shenyang, Liaoning, 110042
- Recruiting
China shenyang the tenth People's Hospital
Shenyang, Liaoning, 110044
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50011
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 30009
- Recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300222
- Recruiting
Weifang People's Hospital
Weifang, Shandong, 261057
- Recruiting
Union Hospital Tongji Medical College Huazhong University Of Science And Technology
Wuhan, Hubei, 430000
- Recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
- Recruiting
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan, 453100
- Recruiting
Yibin Second People's Hospital
Yibin, Sichuan, 644000
- Recruiting
Henan Cancer Center
Zhengzhou, Henan, 450000
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450008
United States21 sites, 21 recruiting
- Recruiting
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
- Recruiting
University of Colorado Health
Aurora, Colorado, 80045
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
- Recruiting
University of Illinois Hospital and Health Sciences Systems
Chicago, Illinois, 60612
- Recruiting
Ohio State University Hospitals
Columbus, Ohio, 43210
- Recruiting
Texas Oncology
Dallas, Texas, 75246
- Recruiting
Henry Ford Cancer Institute
Detroit, Michigan, 48202
- Recruiting
Swedish Cancer Institute
Edmonds, Washington, 98026
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Recruiting
St. Jude Medical Center
Fullerton, California, 92835
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Northwell Health/R.J. Zuckerberg Cancer Center
Lake Success, New York, 11042
- Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
- Recruiting
Columbia University Medical Center
New York, New York, 10032
- Recruiting
Providence St. Joseph Hospital
Orange, California, 92868
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
- Recruiting
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
- Recruiting
Kaiser Permanente Medical Center
Vallejo, California, 94589
- Recruiting
Shenandoah Oncology, P.C.
Winchester, Virginia, 22601
Japan12 sites, 12 recruiting
- Recruiting
Hyogo Cancer Center
Akashi-shi, Hyōgo, 673-8558
- Recruiting
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603
- Recruiting
Tokyo Metropolitan Komagome Hospital
Bunkyō-Ku, Tokyo, 113-8677
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
- Recruiting
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
- Recruiting
Kurume University Hospital
Kurume-Shi, Fukuoka, 830-0011
- Recruiting
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
- Recruiting
Miyagi Cancer Center
Natori-shi, Miyagi, 981-1293
- Recruiting
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
- Recruiting
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
- Recruiting
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192
Canada7 sites, 7 recruiting
- Recruiting
Brampton Civic Hospital, William Osler Health Centre
Brampton, Ontario, L6R 3J7
- Recruiting
Alberta Health Services, Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
- Recruiting
University of Alberta - Cross Cancer Institute (CCI)
Edmonton, Alberta, T6G 1Z2
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
- Recruiting
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, M5G 2M9
- Recruiting
BC Cancer Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
France7 sites, 7 recruiting
- Recruiting
Hospices Civil de Lyon
Bron, Auvergne-Rhône-Alpes, 69500
- Recruiting
Centre Francois Baclesse
Caen, Calvados, 14076
- Recruiting
Centre Leon-Berard
Lyon, 69373
- Recruiting
Hospital Nord de Marseille
Marseille, Bouches-du-Rhone, 13915
- Recruiting
Hopital Nord Guilaume-et-Rene-Laennec CHU de Nantes
Saint-Herblain, 44093
- Recruiting
Insitut de Canderologie d I'Ouest
Saint-Herblain, 44805
- Recruiting
Hopital Larrey
Toulouse, Occitanie, 31059
South Korea7 sites, 7 recruiting
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
- Recruiting
Kyung Hee University Hospital
Seoul, 02447
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Spain5 sites, 5 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hospital QuironSalud Malaga
Málaga, 29004
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, 33011
- Recruiting
Hospital Universitari Son Espases
Palma, Balearic Islands, 07120
- Recruiting
Hospital Universitario y Politecnico La Fe
Valencia, 46026
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Memorial Ankara Hospital
Ankara, Ankara, 06520
- Recruiting
Gulhane Training and Research Hospital
Ankara, 06010
- Recruiting
Anatalya Province
Antalya, 07050
- Recruiting
Medical Park Florya Hospital
Istanbul, 34295
- Recruiting
Istinye University Bahcesehir Liv Hospital
Istanbul, 34517
Australia4 sites, 4 recruiting
- Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, 2148
- Recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
- Recruiting
GenesisCare North Shore Health Hub
St Leonards, New South Wales, 2065
Greece4 sites, 4 recruiting
- Recruiting
Henry Dunant Hospital Center
Athens, 115 26
- Recruiting
University General Hospital Attikon - General Hospital of West Attica H AGIA VARVARA
Athens, 124 62
- Recruiting
Athens Medical Center S.A., European Interbalkan Medical Center
Thessaloniki, 570 01
- Recruiting
Thoracic General Hospital of Athens I Sotiria
Thessaloniki, 570 01
Taiwan4 sites, 4 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
- Recruiting
Taichung Veterans General Hospital
Taichung, 407219
- Recruiting
National Taiwan University Cancer Center
Taipei, 106
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Thailand4 sites, 4 recruiting
- Recruiting
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Bangkok, 10300
- Recruiting
Mahidol University - Siriraj Hospital
Bangkoknoi, Bangkok, 10700
- Recruiting
Prince of Songkla Hospital
Hat Yai, Changwat Songkhla, 90110
- Recruiting
Chulabhorn Hospital
Lak Si, Bangkok, 10210
Hong Kong3 sites, 3 recruiting
- Recruiting
Humanity and Health Clinical Trial Centre
Central
- Recruiting
Queen Mary Hospital
Hong Kong, Hong Kong, 000000
- Recruiting
Prince of Wales Hospital
Shatin, New Territories
Singapore3 sites, 3 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
- Recruiting
Curie Oncology (Farrer)
Singapore, 217562
- Recruiting
Tan Tok Seng Hospital
Singapore, 308433
United Kingdom3 sites, 3 recruiting
- Recruiting
University College London Hospitals NHS Foundation Trust
London, England, NW1 2PG
- Recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
- Recruiting
The Christie NHS Foundation Trust
Manchester, England, M20 4BX
Italy2 sites, 2 recruiting
- Recruiting
SOC Oncologia Medica e dei Tumori Immuno-correlati
Aviano, 33081
- Recruiting
Istituto Europeo di Oncologia (IEO)
Milan, 20141
Malaysia2 sites, 2 recruiting
- Recruiting
Hospital Kuala Lumpur
Kuala Lumpur, WP Kuala Lumpur, 50586
- Recruiting
OncoCar Cancer Centre
Petaling Jaya, Selangor, 47810
About this study
Official title: A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)
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, EGFR Uncommon Mutations
- Being tested
- Firmonertinib, EGFR-TKI inhibitor based on investigator's choice
- 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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Bronchial Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FirmonertinibDrug
Also called AST2818
240 mg oral, daily firmonertinib tablet
EGFR-TKI inhibitor based on investigator's choiceDrug
osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet
| Study group | Role | What they receive |
|---|---|---|
| Firmonertinib 240 mg | Experimental | Not described Receives: Drug: Firmonertinib |
| EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice | Active comparator | Not described Receives: Drug: EGFR-TKI inhibitor based on investigator's choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Until progression or death, assessed up to approximately 3 years
Secondary outcomes (7)
Overall survival (OS)
OS is defined as the time from randomization to death from any cause.
Measured: Until death, assessed up to approximately 5 years
Investigator-assessed PFS
Investigator-assessed PFS is defined as the time from randomization to the first documented disease progression or death, whichever occurs first, based on investigator assessment per RECIST v1.1.
Measured: Until progression or death, assessed up to approximately 4 years
Investigator-assessed confirmed ORR
Investigator-assessed confirmed ORR is defined as the percentage of participants with a confirmed CR or PR based on investigator assessment relative to the total number of participants.
Measured: Until progression or death, assessed up to approximately 3 years
Duration of response (DOR)
DOR is defined as the time from first documented evidence of CR or PR until the first documented evidence of disease progression or death, whichever occurs first.
Measured: Until progression or death, assessed up to approximately 4 years
Time to second Progression-free survival (PFS2)
PFS2 is defined as the time from randomization to second progression (ie, earliest of the subsequent progression events after initiation of a new anti-cancer treatment), or death from any cause, whichever occurs first.
Measured: Assessed up to approximately 5 years
Incidence and severity of adverse events (AEs), as a measure of safety and tolerability of firmonertinib
An AE is defined as any unfavorable or unintended medical occurrence in a trial participant administered a pharmaceutical product, regardless of causal attribution.
Measured: Assessed up to approximately 5 years
Change from baseline in safety-related clinical laboratory test results
Safety-related laboratory parameters include absolute neutrophil count, hemoglobin, platelet count, albumin, blood urea nitrogen (BUN), chloride, creatinine, potassium, sodium, alkaline phosphatase (ALP), alanine aminotransferase (ALT); aspartate aminotransferase (AST), total bilirubin. Each parameter is measured using its standard unit. Changes in participants' laboratory test values are evaluated by comparing baseline (pre-treatment) results with those obtained at prespecified time points during or following the treatment.
Measured: Assessed up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start17 Dec 2025
- Primary completionFeb 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ArriVent BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jamuna Thimmarayappa, Study director, ArriVent BioPharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185997
- Sponsor's protocol ID
- FURMO-006
- Status last verified
- Oct 2026
- First submitted
- 15 Aug 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided