In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy

Официальное название

In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy - PulmoPrint

Обзор

PulmoPrint is a clinical study at the University Medical Center Groningen (UMCG) that investigates why some patients with unresectable stage III lung cancer don't respond to immunotherapy after chemoradiotherapy. To do this, a small dose of a fluorescently labeled version of the immunotherapy drug durvalumab is given via an intravenous (IV) drip, after which a bronchoscopy is performed to visualize where and how much of the drug reaches the tumor and lymph nodes - before the actual durvalumab treatment starts.

Вмешательства

• Препарат Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
  Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT

Первичные конечные точки

• In vivo fluorescence signal of malignant lesions (pulmonary nodule and/or involved lymph node metastases) [Срок оценки: Assessed directly during the bronchoscopy procedure]

Вторичные конечные точки (4)

• Correlation of fluorescence signal with immunohistochemistry (IHC) [Срок оценки: Up to 2 years]
• Correlation of fluorescence signal with event-free survival (EFS) [Срок оценки: Up to 2 years]
• Incidence of adverse events after single durvalumab-680LT injection [Срок оценки: Within 1 week after tracer injection]
• Comparison of the 15 and 25 mg dose durvalumab-680LT [Срок оценки: Assessed directly during the bronchoscopy procedure]

Критерии участия

Критерии включения

• Signed informed consent prior to participation in the study.
• Age ≥ 18 years.
• Histologically or cytologically confirmed unresectable stage III non-small cell lung cancer.
• Completion of concurrent platinum-based chemoradiotherapy
• Eligibility for adjuvant durvalumab per standard of care.
• At least one tumor lesion or involved lymph node accessible by bronchoscopy or endoscopic/endobronchial ultrasound, suitable for biopsy/fine-needle aspiration (FNA) and fluorescence measurement.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Patient is considered fit to undergo a research bronchoscopy (with or without addition of endobronchial ultrasound; including propofol sedation or general anesthesia if either is indicated).

Критерии исключения

• Known history of infusion reactions to durvalumab, other anti-PD-L1 antibodies, or other monoclonal antibodies, according to the patient's medical history.
• Contraindication for bronchoscopy or endoscopic/endobronchial ultrasound (if applicable), including severe uncorrectable coagulopathy, pre-existing severe respiratory insufficiency, or any other clinical reason as judged by the investigator.
• Medical or psychiatric conditions compromising the patient's ability to provide informed consent, according to the treating physician.
• Pregnancy or breastfeeding. A negative pregnancy test must be available for women of childbearing potential on the day of tracer administration.
• Use of an investigational medicinal product within 30 days prior to tracer administration.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07653438 · 24296 · 2026-526251-60-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗