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
Фаза 3 – широко изпитване преди одобрение
Заболявания:
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
Спонсор: ArriVent BioPharma, Inc.
Налично на:
БГ
Обобщение
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.
Кой може да участва
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.
Места на провеждане
13
Австралия (1)
Blacktown Cancer and Haematology Centre
Blacktown , New South Wales
Канада (1)
The Ottawa Hospital Cancer Centre
Ottawa , Ontario
Гърция (1)
Henry Dunant Hospital Center
Athens
Hong Kong (1)
Humanity and Health Clinical Trial Centre
Central
Италия (1)
SOC Oncologia Medica e dei Tumori Immuno-correlati
Aviano
Япония (1)
Aichi Cancer Center
Nagoya , Aichi-ken
Malaysia (1)
Hospital Kuala Lumpur
Kuala Lumpur , WP Kuala Lumpur
Сингапур (1)
National Cancer Centre Singapore
Singapore
Южна Корея (1)
The Catholic University of Korea, St. Vincent's Hospital
Suwon , Gyeonggi-do
Испания (1)
Hospital Universitari Son Espases
Palma , Balearic Islands
Taiwan (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Великобритания (1)
University College London Hospitals NHS Foundation Trust