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Recruiting Phase 3 NCT07185997

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

Phase 3 – large-scale trial before approval
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

Sponsor: ArriVent BioPharma, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 13
Australia (1)
Blacktown Cancer and Haematology Centre
Blacktown , New South Wales
Canada (1)
The Ottawa Hospital Cancer Centre
Ottawa , Ontario
Greece (1)
Henry Dunant Hospital Center
Athens
Hong Kong (1)
Humanity and Health Clinical Trial Centre
Central
Italy (1)
SOC Oncologia Medica e dei Tumori Immuno-correlati
Aviano
Japan (1)
Aichi Cancer Center
Nagoya , Aichi-ken
Malaysia (1)
Hospital Kuala Lumpur
Kuala Lumpur , WP Kuala Lumpur
Singapore (1)
National Cancer Centre Singapore
Singapore
South Korea (1)
The Catholic University of Korea, St. Vincent's Hospital
Suwon , Gyeonggi-do
Spain (1)
Hospital Universitari Son Espases
Palma , Balearic Islands
Taiwan (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
United Kingdom (1)
University College London Hospitals NHS Foundation Trust
London , England
United States (1)
USC/Norris Comprehensive Cancer Center
Los Angeles , California
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
17.12.2025
Completion date
01.12.2030
Registry ID
NCT07185997
Source
anzctr
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