Меню
Набор скоро начнётся NCT06054191

Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations

Фаза II С лечением NSCLC BRAF V600 Mutation MET Exon 14 Mutation

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: Dabrafenib + Trametinib, Capmatinib.
Кому может быть актуально
Состояния в реестре: NSCLC, BRAF V600 Mutation, MET Exon 14 Mutation. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Phase II, Two Parallel Group Study of Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations

Обзор

This is a Phase II, two parallel group study assessing the efficacy and safety of neoadjuvant and adjuvant targeted therapy in patients with stage IB-IIIA NSCLC harboring BRAF V600 or MET exon14 mutations.

Подробное описание

This is a Phase II, two parallel group study assessing the efficacy and safety of neoadjuvant and adjuvant targeted therapy in patients with stage IB-IIIA NSCLC harboring BRAF V600 or MET exon14 mutations. Eligible patients with BRAF V600 mutations will receive dabrafenib 150mg bid plus trametinib 2mg qd for 8 weeks before a surgical resection (neoadjuvant), and followed by up to 4 cycles of adjuvant chemotherapy, if receive adjuvant chemotherapy, up to four cycles, chemo regimen according to investigators' choice, and up to 2 years of adjuvant targeted therapy with dabrafenib plus trametinib. For patients with MET exon14 mutations, they will receive capmatinib 400mg bid for 8 weeks before surgery (neoadjuvant), followed by up to 4 cycles of adjuvant chemotherapy, about adjuvant chemotherapy same as BRAF V600 group, and up to 2 years of adjuvant targeted therapy with capmatinib post-surgery. During treatment, patients will visit their physicians regularly for disease and safety assessment. After the end of treatment, survival follow-up will be conducted every 3 months for up to 3 years. Approximately 40 evaluable patients will be enrolled in the study (20 patients in each cohort).

Вмешательства

  • Препарат Dabrafenib + Trametinib
    Dabrafenib 150mg BID + Trametinib 2mg QD/（2 cycles）
  • Препарат Capmatinib
    Capmatinib 400mg BID/（2 cycles）

Первичные конечные точки

  • Pathological complete response (pCR) rate [Срок оценки: up to 2 years]
Вторичные конечные точки (4)
  • Major pathological response (MPR) rate [Срок оценки: up to 2 years]
  • Event-free survival (EFS) [Срок оценки: up to 3 years]
  • Disease-free survival (DFS) [Срок оценки: up to 3 years]
  • Overall survival (OS) [Срок оценки: up to 3 years]

Критерии участия

Критерии включения

  • 18 years or older.
  • Histologically or cytologically diagnosed stage IB-IIIA and selected IIIB (T3N2, T4N2) NSCLC.
  • Presence of BRAF V600 mutation or METex14 skip mutation in tumor (by PCR or NGS) or blood (by NGS) (pre-treatment biopsy confirmed) in local or other Clinical Laboratory Improvement Amendments (CLIA)-certified lab.
  • Patients whose pre-surgical lesion is measurable, Eligible for surgical resection and scheduled for surgery within 2 weeks after the last does of neoadjuvant treatment.
  • ECOG performance-status score of 0 or 1.
  • No previous anticancer therapy.
  • Patients with stage II or higher non-small-cell lung cancer (NSCLC) and those with suspected brain metastases should have brain imaging (CT or MRI) prior to enrollment to exclude brain metastasis.
  • Could provide pretreatment tumor samples available for biomarker analysis. The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent.

Критерии исключения

  • Patients with unresectable (regardless of stage) or metastatic disease (stage IV) or brain metastases.
  • Contain neuroendocrine carcinoma tumor histology.
  • Major surgery within 4 weeks before enrollment, or who have not recovered from side effects of related procedures.
  • History of current interstitial lung disease or pneumonitis.
  • Patients with conditions requiring systemic corticosteroids (>10 mg daily prednisone or equivalent) or immunosuppressive medication within 14 days of the first dose of study drug (Inhaled or topical steroids and adrenal-replacement steroids are allowed).
  • History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected).
  • Pregnant or lactating women.
  • Those who are allergic to the research drug or its components.
  • Subjects who are deemed unable to comply with the study requirements or complete the study.
  • Those with acquired immunodeficiency syndrome, or any uncontrolled medical disorder, or insufficient function of bone marrow or other important organs.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Cancer Center of Sun-Yat Sen University — Гуанчжоу

Идентификаторы

NCT: NCT06054191 · B2023-331-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗