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Идёт набор NCT07073365

Bolstering Outcomes After Induction With Osimertinib Plus Chemotherapy Through Optimized Site-Directed Primary Tumor Therapy (BOOST Trial)

Фаза II С лечением Non-Small Cell Lung Cancer Epidermal Growth Factor Receptor

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: Local Therapy (Surgery or Radiotherapy).
Кому может быть актуально
Состояния в реестре: Non-Small Cell Lung Cancer, Epidermal Growth Factor Receptor. Базовые параметры: от 20 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
South Korea
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 Prospective Cohort Observational Study of Local Therapy for the Primary Tumor in EGFR-Mutant Advanced Non-Small Cell Lung Cancer Following Osimertinib Plus Chemotherapy (FLAURA2 Regimen)

Обзор

This is a single-arm, open-label, phase II study evaluating the clinical outcomes of local therapy (surgery or radiotherapy) to the primary tumor in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC) who have achieved disease control following first-line treatment with the FLAURA2 regimen (osimertinib plus platinum-based chemotherapy). The primary objective is to assess the median progression-free survival (PFS) after local therapy.

Подробное описание

This prospective, single-arm, multicenter observational study is designed to estimate the median progression-free survival (PFS) in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC) who receive salvage local treatment after achieving disease control with first-line osimertinib plus chemotherapy. A total of 70 patients will be enrolled. The primary endpoint is median PFS, and the sample size was calculated to ensure that the 95% confidence interval around the estimated median has a width of no more than ±3 months, using Greenwood's approximation. Patients will be followed for a minimum of 24 months after the last enrollment, with an overall study duration of up to 72 months.

Вмешательства

  • Другое Local Therapy (Surgery or Radiotherapy)
    Patients will receive local therapy, either surgical resection or radiotherapy, to the primary lung tumor following disease control after first-line treatment with osimertinib plus platinum-based chemotherapy (FLAURA2 regimen). The specific modality (surgery or radiotherapy) will be determined based on tumor characteristics, patient condition, and multidisciplinary team assessment.

Первичные конечные точки

  • Median progression-free survival (PFS) [Срок оценки: Up to 60 months (through June 30, 2030; patients followed for ≥24 months after last enrollment)]
Вторичные конечные точки (3)
  • Overall survival (OS) [Срок оценки: Up to 72 months (through June 30, 2031)]
  • Local Control Rate [Срок оценки: Up to 60 months (through June 30, 2030)]
  • Adverse events (AEs) [Срок оценки: Up to 60 months (through June 30, 2030)]

Критерии участия

<Inclusion Criteria>

Participants must meet all of the following criteria to be eligible:

  • Age ≥ 20 years at the time of consent.
  • Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
  • Presence of activating EGFR mutation (exon 19 deletion or L858R).
  • Stage IV (metastatic) NSCLC at initial diagnosis.
  • Completion of four cycles of first-line osimertinib plus platinum-based chemotherapy (FLAURA2 regimen).
  • Radiologic evidence of disease control (complete response, partial response, or stable disease) after systemic therapy.
  • Residual primary lung tumor suitable for local therapy (surgery or radiotherapy), as determined by multidisciplinary evaluation.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function based on institutional laboratory criteria.
  • Ability to understand and willingness to provide written informed consent.

<Exclusion Criteria>

Participants will be excluded if they meet any of the following criteria:

  • Radiologic or clinical evidence of progressive disease during first-line osimertinib-chemotherapy.
  • Extensive, unresectable metastatic disease not amenable to local therapy.
  • Untreated or clinically unstable brain metastases.
  • Known contraindications to surgery or radiotherapy.
  • Active second malignancy requiring concurrent treatment.
  • Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results.
  • Pregnancy or breastfeeding at the time of enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Pusan National University Hospital — Busan

Публикации

  • Kim MH, Seong H, Kim SH, Eom JS. Local consolidative therapy for the primary tumor in EGFR-mutant advanced non-small cell lung cancer following osimertinib plus chemotherapy: a protocol for a single-arm, open-label, phase 2 trial. Transl Lung Cancer Res. 2025 Oct 31;14(10):4666-4674. doi: 10.21037/tlcr-2025-922. Epub 2025 Oct 29. PMID 41234591

Идентификаторы

NCT: NCT07073365 · PNU-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗