Идёт набор 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
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Firmonertinib, EGFR-TKI inhibitor based on investigator's choice.
- Кому может быть актуально
- Состояния в реестре: 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. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Австралия, Канада, Франция, Греция +11
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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)
Обзор
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.
Вмешательства
- Препарат Firmonertinib
240 mg oral, daily firmonertinib tablet - Препарат EGFR-TKI inhibitor based on investigator's choice
osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet
Первичные конечные точки
- Progression Free Survival (PFS) determined by blinded independent central review (BICR) [Срок оценки: Until progression or death, assessed up to approximately 4 years]
- Confirmed overall response rate (ORR) as determined by BICR [Срок оценки: Until progression or death, assessed up to approximately 3 years]
Вторичные конечные точки (7)
- Overall survival (OS) [Срок оценки: Until death, assessed up to approximately 5 years]
- Investigator-assessed PFS [Срок оценки: Until progression or death, assessed up to approximately 4 years]
- Investigator-assessed confirmed ORR [Срок оценки: Until progression or death, assessed up to approximately 3 years]
- Duration of response (DOR) [Срок оценки: Until progression or death, assessed up to approximately 4 years]
- Time to second Progression-free survival (PFS2) [Срок оценки: Assessed up to approximately 5 years]
- Incidence and severity of adverse events (AEs), as a measure of safety and tolerability of firmonertinib [Срок оценки: Assessed up to approximately 5 years]
- Change from baseline in safety-related clinical laboratory test results [Срок оценки: Assessed up to approximately 5 years]
Критерии участия
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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 20 центров
- St. Jude Medical Center — Fullerton
- USC/Norris Comprehensive Cancer Center — Los Angeles
- Providence St. Joseph Hospital — Orange
- University of California Davis Comprehensive Cancer Center — Sacramento
- UCSF Medical Center-Mission Bay — San Francisco
- Kaiser Permanente Medical Center — Vallejo
- University of Colorado Health — Aurora
- Illinois Cancer Specialists — Arlington Heights
- … и ещё 12 центров
Япония · 11 центров
- Aichi Cancer Center — Nagoya
- National Cancer Center Hospital East — Kashiwa
- Kurume University Hospital — Kurume-Shi
- National Hospital Organization Hokkaido Cancer Center — Sapporo
- Hyogo Cancer Center — Akashi-shi
- Miyagi Cancer Center — Natori-shi
- Niigata Cancer Center Hospital — Niigata
- Kansai Medical University Hospital — Hirakata-shi
- … и ещё 3 центра
Франция · 7 центров
- Hospices Civil de Lyon — Bron
- Hospital Nord de Marseille — Marseille
- Centre Francois Baclesse — Caen
- Hopital Larrey — Toulouse
- Centre Leon-Berard — Lyon
- Hopital Nord Guilaume-et-Rene-Laennec CHU de Nantes — Saint-Herblain
- Insitut de Canderologie d I'Ouest — Saint-Herblain
South Korea · 7 центров
- The Catholic University of Korea, St. Vincent's Hospital — Suwon
- Chonnam National University Hwasun Hospital — Hwasun
- Gachon University Gil Medical Center — Incheon
- Kyung Hee University Hospital — Seoul
- Kangbuk Samsung Hospital — Seoul
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
Канада · 6 центров
- Alberta Health Services, Tom Baker Cancer Centre — Calgary
- BC Cancer Vancouver Centre — Vancouver
- Brampton Civic Hospital, William Osler Health Centre — Brampton
- The Ottawa Hospital Cancer Centre — Ottawa
- Sunnybrook Research Institute — Toronto
- Princess Margaret Cancer Centre - University Health Network — Toronto
Испания · 5 центров
- Hospital Universitari Son Espases — Palma
- Hospital Clinic de Barcelona — Barcelona
- Hospital QuironSalud Malaga — Málaga
- Hospital Universitario Central de Asturias — Oviedo
- Hospital Universitario y Politecnico La Fe — Valencia
Австралия · 4 центра
- Blacktown Cancer and Haematology Centre — Blacktown
- Chris O'Brien Lifehouse — Camperdown
- GenesisCare North Shore Health Hub — St Leonards
- Austin Health — Heidelberg
Греция · 4 центра
- Henry Dunant Hospital Center — Athens
- University General Hospital Attikon - General Hospital of West Attica H AGIA VARVARA — Athens
- Athens Medical Center S.A., European Interbalkan Medical Center — Thessaloniki
- Thoracic General Hospital of Athens I Sotiria — Thessaloniki
Тайвань · 4 центра
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
- Taichung Veterans General Hospital — Taichung
- National Taiwan University Cancer Center — Taipei
- Taipei Veterans General Hospital — Taipei
Таиланд · 4 центра
- Mahidol University - Siriraj Hospital — Bangkoknoi
- Chulabhorn Hospital — Lak Si
- Prince of Songkla Hospital — Hat Yai
- … и ещё 1 центр
Turkey (Türkiye) · 4 центра
Список центров уточняется — проверьте первичный протокол.
Сингапур · 3 центра
- National Cancer Centre Singapore — Singapore
- Curie Oncology (Farrer) — Singapore
- Tan Tok Seng Hospital — Singapore
Великобритания · 3 центра
Список центров уточняется — проверьте первичный протокол.
Гонконг · 2 центра
- Humanity and Health Clinical Trial Centre — Central
- Queen Mary Hospital — Гонконг
Италия · 2 центра
- SOC Oncologia Medica e dei Tumori Immuno-correlati — Aviano
- Istituto Europeo di Oncologia (IEO) — Milan
Малайзия · 2 центра
- OncoCar Cancer Centre — Petaling Jaya
- Hospital Kuala Lumpur — Kuala Lumpur
Идентификаторы
NCT: NCT07185997 · FURMO-006