Fluorescence bronchoscopy to study the distribution of immunotherapy in the tumour and lymph nodes following chemoradiation — PulmoPrint

Prior treatment

• Use of an investigational medicinal product within 30 days prior to tracer administration.

Other illness

• 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.

Other

• Pregnancy or breastfeeding. A negative pregnancy test must be available for women of childbearing potential on the day of tracer administration.

• 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 0–2.
• 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).