Actively Recruiting
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
Led by ArriVent BioPharma, Inc. · Updated on 2026-05-11
480
Participants Needed
62
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic Non-Small Cell Lung Cancer not suitable for curative surgery or radiotherapy
- Documented presence of EGFR PACC mutation in tumor tissue or blood from local testing
- No prior systemic anticancer therapy for locally advanced or metastatic NSCLC, including no previous treatment with EGFR-targeting agents such as TKIs, monoclonal, or bispecific antibodies
- If prior neo-adjuvant or adjuvant chemotherapy, immunotherapy, or chemoradiotherapy was given for non-metastatic disease, a treatment-free interval of at least 12 months is required
- Patients with asymptomatic central nervous system metastases are eligible
You will not qualify if you...
- Prior systemic anticancer therapy for locally advanced or metastatic NSCLC, including any EGFR-targeting therapy
- Inability to provide documented results confirming EGFR PACC mutation
- Patients who have received prior treatment for advanced disease
- Patients with symptomatic CNS metastases requiring immediate intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 62 locations
1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
3
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
4
Kaiser Permanente Medical Center
Vallejo, California, United States, 94589
Actively Recruiting
5
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Actively Recruiting
6
University of Illinois Hospital and Health Sciences Systems
Chicago, Illinois, United States, 60612
Actively Recruiting
7
Northwell Health/R.J. Zuckerberg Cancer Center
Lake Success, New York, United States, 11042
Actively Recruiting
8
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
9
Ohio State University Hospitals
Columbus, Ohio, United States, 43210
Actively Recruiting
10
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
11
Texas Oncology
Dallas, Texas, United States, 75246
Actively Recruiting
12
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
13
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
14
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
15
Shenandoah Oncology, P.C.
Winchester, Virginia, United States, 22601
Actively Recruiting
16
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
17
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
18
GenesisCare North Shore Health Hub
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
19
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
20
BC Cancer Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
21
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
22
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
23
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
24
Henry Dunant Hospital Center
Athens, Greece, 115 26
Actively Recruiting
25
University General Hospital Attikon - General Hospital of West Attica H AGIA VARVARA
Athens, Greece, 124 62
Actively Recruiting
26
Athens Medical Center S.A., European Interbalkan Medical Center
Thessaloniki, Greece, 570 01
Actively Recruiting
27
Thoracic General Hospital of Athens I Sotiria
Thessaloniki, Greece, 570 01
Actively Recruiting
28
Humanity and Health Clinical Trial Centre
Central, Hong Kong
Actively Recruiting
29
Queen Mary Hospital
Hong Kong, Hong Kong, 000000
Actively Recruiting
30
SOC Oncologia Medica e dei Tumori Immuno-correlati
Aviano, Italy, 33081
Actively Recruiting
31
Istituto Europeo di Oncologia (IEO)
Milan, Italy, 20141
Actively Recruiting
32
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
33
Kurume University Hospital
Kurume-Shi, Fukuoka, Japan, 830-0011
Actively Recruiting
34
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
Actively Recruiting
35
Hyogo Cancer Center
Akashi-shi, Hyōgo, Japan, 673-8558
Actively Recruiting
36
Miyagi Cancer Center
Natori-shi, Miyagi, Japan, 981-1293
Actively Recruiting
37
Niigata Cancer Center Hospital
Niigata, Niigata, Japan, 951-8566
Actively Recruiting
38
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan, 573-1191
Actively Recruiting
39
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan, 113-8603
Actively Recruiting
40
Tokyo Metropolitan Komagome Hospital
Bunkyō-Ku, Tokyo, Japan, 113-8677
Actively Recruiting
41
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
42
Hospital Kuala Lumpur
Kuala Lumpur, WP Kuala Lumpur, Malaysia, 50586
Actively Recruiting
43
National Cancer Centre Singapore
Singapore, Singapore, 168583
Actively Recruiting
44
Curie Oncology (Farrer)
Singapore, Singapore, 217562
Actively Recruiting
45
Tan Tok Seng Hospital
Singapore, Singapore, 308433
Actively Recruiting
46
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
47
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea, 58128
Actively Recruiting
48
Gachon University Gil Medical Center
Incheon, South Korea, 21565
Actively Recruiting
49
Kangbuk Samsung Hospital
Seoul, South Korea, 03181
Actively Recruiting
50
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
51
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
52
Hospital Universitari Son Espases
Palma, Balearic Islands, Spain, 07120
Actively Recruiting
53
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
54
Hospital QuironSalud Malaga
Málaga, Spain, 29004
Actively Recruiting
55
Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
Actively Recruiting
56
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
57
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
58
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
Actively Recruiting
59
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
60
University College London Hospitals NHS Foundation Trust
London, England, United Kingdom, NW1 2PG
Actively Recruiting
61
The Christie NHS Foundation Trust
Manchester, England, United Kingdom, M20 4BX
Actively Recruiting
62
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
Research Team
V
Vanessa Esquibel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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