In-vivo fluorescence molecular bronchoscopy of durvalumab-680LT in patients with unresectable stage III NSCLC after chemoradiation - PulmoPrint
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- In vivo fluorescent signal of malignant lesions (pulmonary nodule or involved lymph node metastasis) assessed semi-quantitatively (tumor-to-background ratio [TBR]/contrast-to-noise ratio) and quantitatively (continuous data by MDSFR/SFF spectroscopy [pulmonary lesion] and/or USNB/SFF spectroscopy [lymph nodes] measurement). The signal is considered sufficient when a TBR greater than 2 is achieved, assessed both by the fluorescence camera system and by the spectroscopy system.
研究概览
简要总结
To assess in-vivo durvalumab-680LT distribution in the lung tumor and involved lymph nodes post-CRT but before initiation of durvalumab treatment via fluorescence molecular bronchoscopy
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to participation in the study.
- •Age ≥ 18 years.
- •Histologically or cytologically confirmed unresectable stage III NSCLC.
- •Completion of concurrent platinum-based CRT (at least radiotherapy needs to be provided in the UMCG).
- •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/FNA and fluorescence measurement.
- •ECOG performance status 0–
- •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).
排除标准
- •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.
结局指标
主要结局
In vivo fluorescent signal of malignant lesions (pulmonary nodule or involved lymph node metastasis) assessed semi-quantitatively (tumor-to-background ratio [TBR]/contrast-to-noise ratio) and quantitatively (continuous data by MDSFR/SFF spectroscopy [pulmonary lesion] and/or USNB/SFF spectroscopy [lymph nodes] measurement). The signal is considered sufficient when a TBR greater than 2 is achieved, assessed both by the fluorescence camera system and by the spectroscopy system.
In vivo fluorescent signal of malignant lesions (pulmonary nodule or involved lymph node metastasis) assessed semi-quantitatively (tumor-to-background ratio [TBR]/contrast-to-noise ratio) and quantitatively (continuous data by MDSFR/SFF spectroscopy [pulmonary lesion] and/or USNB/SFF spectroscopy [lymph nodes] measurement). The signal is considered sufficient when a TBR greater than 2 is achieved, assessed both by the fluorescence camera system and by the spectroscopy system.
次要结局
- In vivo and ex vivo fluorescence signal, PD-L1 IHC score (assessed according to standard pathology protocols).
- In vivo and ex vivo fluorescence signal, 1-, 2-and 5-year (long-term exploratory endpoint) event-free survival (defined as the time from the date of start of durvalumab treatment (index) to the first occurrence of any of the event (i) Disease progression, ii) Death from any cause. Patients who have not experienced an event at the time of analysis are censored.
- In vivo tumor-to-background ratio (please also refer to primary endpoint).
- Adverse events according to CTCAE v5.0
研究者
Frederike Bensch
Scientific
Universitair Medisch Centrum Groningen