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.
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
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.
Sequential
Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
DrugFluorescence molecular imaging during bronchoscopy with durvalumab-680LT
In vivo fluorescence signal of malignant lesions (pulmonary nodule and/or involved lymph node metastases)
In vivo fluorescence signal of malignant lesions (pulmonary nodule and/or involved lymph node metastases) assessed semi-quantitatively (tumor-to-background ratio \[TBR\]/contrast-to-noise ratio) and quantitatively (continuous data by multi-diameter single-fiber reflectance (MDSFR)/single-fiber fluorescence (SFF) spectroscopy \[pulmonary lesion\] and/or Ultrasound-guided needle biopsy (USNB)/SFF spectroscopy \[lymph nodes\] measurement). The signal is considered sufficient when a tumor-to-background ratio (TBR) greater than 2 is achieved, assessed both by the fluorescence camera system and by the spectroscopy system. (The comparison of the fluorescence signal between lesion and background is a supportive exploratory analysis intended to characterize signal distribution; it does not constitute evidence of diagnostic or comparative performance.)
Correlation of fluorescence signal with immunohistochemistry (IHC)
In vivo and ex vivo fluorescence signal, programmed-death ligand 1 (PD-L1) immunohistochemistry (IHC) score (assessed according to standard pathology protocols).
Correlation of fluorescence signal with event-free survival (EFS)
In vivo and ex vivo fluorescence signal, 1-, 2-and 5-year (long-term exploratory endpoint) event-free survival (EFS).
Incidence of adverse events after single durvalumab-680LT injection
Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Comparison of the 15 and 25 mg dose durvalumab-680LT
in vivo tumor-to-background ratio of 15 mg versus 25 mg
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This trial is not recruiting at the moment. You can still explore other options:
