Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients
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: Glumetinib Tablets, Osimertinib Mesylate Tablets, Glumetinib Tablets Placebo.
- Кому может быть актуально
- Состояния в реестре: Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression. Базовые параметры: 18 лет — 75 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
- Список центров уточняется — проверьте первичный протокол.
- 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 Multicenter Phase II/III Clinical Study on the Efficacy and Safety of Glumetinib Combined With Osimertinib as First-Line Treatment in Non-Small Cell Lung Cancer Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression
Обзор
To evaluate the efficacy and safety of glumetinib combined with osimertinib as the first-line treatment for locally advanced or metastatic NSCLC.
Подробное описание
In the Phase II stage, eligible subjects who have passed screening will be randomly assigned in a 1:1:1 ratio into the Group 1, Group 2, and Group 3 to receive study treatment:
In the Phase III stage, eligible subjects who have passed screening will be randomly assigned in a 1:1 ratio into the test group and the control group to receive the study treatments, and the RP3D obtained from Phase II will be used as the dose of glumetinib for the test group.
Randomization stratification factors include: c-MET status (≥2+, ≥75% and 3+, \<50% vs 3+, ≥50% or FISH positive), and EGFR-sensitive mutation type (19Del vs L858R).
In both the Phase II and Phase III stages, each treatment cycle is every 3 weeks, with continuous treatment until progressive disease (PD) confirmed by the investigator, intolerable toxicity, withdrawal of informed consent by the subject, loss to follow-up, death, or other criteria for terminating treatment as specified in the protocol, whichever occurs first.
Вмешательства
- Препарат Glumetinib Tablets
An ATP competitive, highly selective MET receptor tyrosine kinase inhibitor - Препарат Osimertinib Mesylate Tablets
3rd EGFR-TKI - Препарат Glumetinib Tablets Placebo
Placebo
Первичные конечные точки
- Phase 2：ORR as assessed by IRC [Срок оценки: Up to approximately 30 months after the first participant is enrolled]
Вторичные конечные точки (11)
- Phase 2：ORR as assessed by investigator [Срок оценки: Up to approximately 30 months after the first participant is enrolled]
- phase 2：PFS as assessed by IRC and investigator [Срок оценки: Up to approximately 30 months after the first participant is enrolled]
- Phase 3：PFS as assessed by invetigator [Срок оценки: Up to approximately 30 months after the first participant is enrolled]
- Phase 3：ORR as assessed by IRC and investigator [Срок оценки: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：OS [Срок оценки: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：DCR as assessed by IRC and investigator [Срок оценки: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：DoR as assessed by IRC and investigator [Срок оценки: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：TTR as assessed by IRC and investigator [Срок оценки: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：Frequency and severity of AEs (NCI CTCAE 5.0) [Срок оценки: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：PK parameters: The plasma concentration of glumetinib [Срок оценки: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：Biomarkers: c-MET expression and amplification levels, tumor-related gene mutations [Срок оценки: Up to approximately 30 months after the first participant is enrolled]
Критерии участия
Критерии включения
- 1\. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Male or female subjects aged 18 to 75 years (inclusive). 3. Patients with NSCLC who have unresectable locally advanced or metastatic disease; 4. At least one measurable lesion, as defined by RECIST 1.1 criteria; 5. ECOG performance status of 0 or 1; 6. Expected survival ≥ 3 months; 7. Adequate function of major organs and bone marrow; 8. Women or man of childbearing potential must use highly effective contraception.
Критерии исключения
- Prior treatment with an EGFR inhibitor or MET inhibitor;
- Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;
- Patients who have taken strong inducers or inhibitors of CYP3A4 within 2 weeks prior to the first dose of the study drug, or who cannot discontinue the use of strong CYP3A4 inducers and inhibitors during the study;
- Patients with a history of autoimmune diseases, a history of immunodeficiency, including positive for HIV, or other acquired or congenital immunodeficiency diseases, or a history of organ transplant;
- Presence of active infection (e.g., subjects are receiving anti-infection therapy);
- Severe or uncontrolled cardiovascular disorder requiring treatment;
- Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;
- Women who are pregnant or breastfeeding;
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
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06908772 · SYH2065-003