Fact CheckerSign in

NCT07185997RecruitingPhase 3

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 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)

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
480 (estimated)
First submitted
15 Aug 2025
Start date
17 Dec 2025
Primary completion date
28 Feb 2029
Lead sponsor
ArriVent BioPharma, Inc.
Diseases
Lung cancer
NCT number
NCT07185997

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 480
  • From 17 Dec 2025 to the primary completion date, 28 Feb 2029
  • 141 sites in 17 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (141)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Blacktown Cancer and Haematology Centre
Coordinator of this site? Confirm its status
BlacktownAustraliaRecruiting
Chris O'Brien Lifehouse
Coordinator of this site? Confirm its status
CamperdownAustraliaRecruiting
Austin Health
Coordinator of this site? Confirm its status
HeidelbergAustraliaRecruiting
GenesisCare North Shore Health Hub
Coordinator of this site? Confirm its status
St LeonardsAustraliaRecruiting
Brampton Civic Hospital, William Osler Health Centre
Coordinator of this site? Confirm its status
BramptonCanadaRecruiting
Alberta Health Services, Tom Baker Cancer Centre
Coordinator of this site? Confirm its status
CalgaryCanadaRecruiting
University of Alberta - Cross Cancer Institute (CCI)
Coordinator of this site? Confirm its status
EdmontonCanadaRecruiting
The Ottawa Hospital Cancer Centre
Coordinator of this site? Confirm its status
OttawaCanadaRecruiting
Princess Margaret Cancer Centre - University Health Network
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Sunnybrook Research Institute
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
BC Cancer Vancouver Centre
Coordinator of this site? Confirm its status
VancouverCanadaRecruiting
Peking University People's Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Beijing chest hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Peking University Cancer Hospital (PKUCH)/Beijing Cancer Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Hunan Cancer Hospital
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
Xiangya Hospital of Central South University
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
Profile of The Third Xiangya Hospital of Central South University
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
Sichuan Cancer Hospital
Coordinator of this site? Confirm its status
ChengduChinaRecruiting
West China Hospital of Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaRecruiting
The First Affiliated Hospital of Chongqing Medical University
Coordinator of this site? Confirm its status
ChongqingChinaRecruiting
The Second Hospital of Dalian Medical University
Coordinator of this site? Confirm its status
DalianChinaRecruiting
The First People's Hospital of Foshan
Coordinator of this site? Confirm its status
FoshanChinaRecruiting
Fujian Cancer Hospital
Coordinator of this site? Confirm its status
FuzhouChinaRecruiting
Nanfang Hospital, Southern Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
The First Affiliated Hospital, Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Zhejiang Cancer Hospital
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Harbin Medical University Cancer Hospital
Coordinator of this site? Confirm its status
HarbinChinaRecruiting
Anhui Provincial Hospital
Coordinator of this site? Confirm its status
HefeiChinaRecruiting
The Affiliated Hospital of Inner Mongolia Medical University
Coordinator of this site? Confirm its status
HohhotChinaRecruiting
Jinan Central Hospital
Coordinator of this site? Confirm its status
JinanChinaRecruiting
Yunnan Cancer Hospital
Coordinator of this site? Confirm its status
KunmingChinaRecruiting
LinYi Cancer Hospital
Coordinator of this site? Confirm its status
LinyiChinaRecruiting
The First Affiliated Hospital of Henan University of Science &Technology
Coordinator of this site? Confirm its status
LuoyangChinaRecruiting
The First Affiliated Hospital of NanChang University
Coordinator of this site? Confirm its status
NanchangChinaRecruiting
Jiangsu Province Hospital
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Nanjing Drum Tower hospital
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Guangxi Medical University Cancer Hospital
Coordinator of this site? Confirm its status
NanningChinaRecruiting
Affiliated Hospital of Nantong University
Coordinator of this site? Confirm its status
NantongChinaRecruiting
The Affiliated Hospital of Qingdao University
Coordinator of this site? Confirm its status
QingdaoChinaRecruiting
Shanghai Geriatric Medical Center
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Shanghai Pulmonary Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Shanghai Chest Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Cancer Hospital of Shantou University Medical College
Coordinator of this site? Confirm its status
ShantouChinaRecruiting
China shenyang the tenth People's Hospital
Coordinator of this site? Confirm its status
ShenyangChinaRecruiting
Cancer hospital of Dalian university of technology
Coordinator of this site? Confirm its status
ShenyangChinaRecruiting
The First Hospital of China Medical University
Coordinator of this site? Confirm its status
ShenyangChinaRecruiting
The Fourth Hospital of Hebei Medical University
Coordinator of this site? Confirm its status
ShijiazhuangChinaRecruiting
Shanxi Cancer hospital
Coordinator of this site? Confirm its status
TaiyuanChinaRecruiting
Tianjin Medical University Cancer Institute & Hospital
Coordinator of this site? Confirm its status
TianjinChinaRecruiting
Tianjin Chest Hospital
Coordinator of this site? Confirm its status
TianjinChinaRecruiting
Weifang People's Hospital
Coordinator of this site? Confirm its status
WeifangChinaRecruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaRecruiting
Zhongshan Hospital Xiamen University
Coordinator of this site? Confirm its status
XiamenChinaRecruiting
The First Affiliated Hospital of Henan Medical University
Coordinator of this site? Confirm its status
XinxiangChinaRecruiting
Yibin Second People's Hospital
Coordinator of this site? Confirm its status
YibinChinaRecruiting
Henan Cancer Center
Coordinator of this site? Confirm its status
ZhengzhouChinaRecruiting
The First Affiliated Hospital of Zhengzhou University
Coordinator of this site? Confirm its status
ZhengzhouChinaRecruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Quironsalud Malaga
Coordinator of this site? Confirm its status
MálagaSpainRecruiting
Hospital Universitario Central De Asturias
Coordinator of this site? Confirm its status
OviedoSpainRecruiting
Hospital Universitari Son Espases
Coordinator of this site? Confirm its status
PalmaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Hospices Civil de Lyon
Coordinator of this site? Confirm its status
BronFranceRecruiting
Centre François Baclesse
Coordinator of this site? Confirm its status
CaenFranceRecruiting
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Hospital Nord de Marseille
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Hopital Nord Guilaume-et-Rene-Laennec CHU de Nantes
Coordinator of this site? Confirm its status
Saint-HerblainFranceRecruiting
Insitut de Canderologie d I'Ouest
Coordinator of this site? Confirm its status
Saint-HerblainFranceRecruiting
Hopital Larrey
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
The Royal Marsden NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
University College London Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust
Coordinator of this site? Confirm its status
ManchesterUnited KingdomRecruiting
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
Henry Dunant Hospital Center
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
Thoracic General Hospital of Athens I Sotiria
Coordinator of this site? Confirm its status
ThessalonikiGreeceRecruiting
Athens Medical Center S.A., European Interbalkan Medical Center
Coordinator of this site? Confirm its status
ThessalonikiGreeceRecruiting
Humanity and Health Clinical Trial Centre
Coordinator of this site? Confirm its status
CentralHong Kong SAR ChinaRecruiting
Queen Mary Hospital
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaRecruiting
Prince of Wales Hospital
Coordinator of this site? Confirm its status
ShatinHong Kong SAR ChinaRecruiting
SOC Oncologia Medica e dei Tumori Immuno-correlati
Coordinator of this site? Confirm its status
AvianoItalyRecruiting
Istituto Europeo di Oncologia (IEO)
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Hyogo Cancer Center
Coordinator of this site? Confirm its status
Akashi-shiJapanRecruiting
Nippon Medical School Hospital
Coordinator of this site? Confirm its status
Bunkyo-kuJapanRecruiting
Tokyo Metropolitan Komagome Hospital
Coordinator of this site? Confirm its status
Bunkyo KuJapanRecruiting
National Cancer Center Hospital
Coordinator of this site? Confirm its status
Chuo KuJapanRecruiting
Kansai Medical University Hospital
Coordinator of this site? Confirm its status
Hirakata-shiJapanRecruiting
National Cancer Center Hospital East
Coordinator of this site? Confirm its status
KashiwaJapanRecruiting
Kurume University Hospital
Coordinator of this site? Confirm its status
Kurume-shiJapanRecruiting
Aichi Cancer Center
Coordinator of this site? Confirm its status
NagoyaJapanRecruiting
Miyagi Cancer Center
Coordinator of this site? Confirm its status
Natori-shiJapanRecruiting
Niigata Cancer Center Hospital
Coordinator of this site? Confirm its status
NiigataJapanRecruiting
National Hospital Organization Hokkaido Cancer Center
Coordinator of this site? Confirm its status
SapporoJapanRecruiting
Fujita Health University Hospital
Coordinator of this site? Confirm its status
ToyoakeJapanRecruiting
Chonnam National University Hwasun Hospital
Coordinator of this site? Confirm its status
HwasunSouth KoreaRecruiting
Gachon University Gil Medical Center
Coordinator of this site? Confirm its status
IncheonSouth KoreaRecruiting
Kangbuk Samsung Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Kyung Hee University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
The Catholic University of Korea St. Vincent's Hospital
Coordinator of this site? Confirm its status
SuwonSouth KoreaRecruiting
Hospital Kuala Lumpur
Coordinator of this site? Confirm its status
Kuala LumpurMalaysiaRecruiting
OncoCar Cancer Centre
Coordinator of this site? Confirm its status
Petaling JayaMalaysiaRecruiting
Curie Oncology (Farrer)
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting
Tan Tok Seng Hospital
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting
National Cancer Centre Singapore
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Coordinator of this site? Confirm its status
BangkokThailandRecruiting
Mahidol University - Siriraj Hospital
Coordinator of this site? Confirm its status
BangkoknoiThailandRecruiting
Prince of Songkla Hospital
Coordinator of this site? Confirm its status
Hat YaiThailandRecruiting
Chulabhorn Hospital
Coordinator of this site? Confirm its status
Lak SiThailandRecruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanRecruiting
Taichung Veterans General Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanRecruiting
Taipei Veterans General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
National Taiwan University Cancer Center
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Illinois Cancer Specialists
Coordinator of this site? Confirm its status
Arlington HeightsUnited StatesRecruiting
University of Colorado Health
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
University of Virginia
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesRecruiting
University of Illinois Hospital and Health Sciences Systems
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Ohio State University Hospitals
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Texas Oncology
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Henry Ford Cancer Institute
Coordinator of this site? Confirm its status
DetroitUnited StatesRecruiting
Swedish Cancer Institute
Coordinator of this site? Confirm its status
EdmondsUnited StatesRecruiting
Virginia Cancer Specialists
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
St. Jude Medical Center
Coordinator of this site? Confirm its status
FullertonUnited StatesRecruiting
The University of Texas MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Northwell Health/R.J. Zuckerberg Cancer Center
Coordinator of this site? Confirm its status
Lake SuccessUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Columbia University Medical Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Providence St. Joseph Hospital
Coordinator of this site? Confirm its status
OrangeUnited StatesRecruiting
Fox Chase Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
University of California Davis Comprehensive Cancer Center
Coordinator of this site? Confirm its status
SacramentoUnited StatesRecruiting
UCSF Medical Center-Mission Bay
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting
Kaiser Permanente Medical Center
Coordinator of this site? Confirm its status
VallejoUnited StatesRecruiting
Shenandoah Oncology, P.C.
Coordinator of this site? Confirm its status
WinchesterUnited StatesRecruiting
Gulhane Training and Research Hospital
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Memorial Ankara Hospital
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Anatalya Province
Coordinator of this site? Confirm its status
AntalyaTurkey (Türkiye)Recruiting
Istinye University Bahcesehir Liv Hospital
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Recruiting
Medical Park Florya Hospital
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.