In-vivo Fluorescence Molecular Bronchoscopy of Dur-valumab-680LT in Patients With Unresectable Stage III NSCLC After Chemoradiation (PulmoPrint)

In-vivo Fluorescence Molecular Bronchoscopy of Dur-valumab-680LT in Patients With Unresectable Stage III NSCLC After Chemoradiation - PulmoPrint

PulmoPrint is a clinical study at UMCG that investigates why some patients with unresectable stage III lung cancer stop responding to immunotherapy after chemoradiation. To do this, a small dose of a fluorescently labeled version of the immunotherapy drug durvalumab is given via an IV drip, after which a camera bronchoscopy is performed to visualize where and how much of the drug actually reaches the tumor and lymph nodes - before the actual durvalumab treatment starts.

Study Overview

• Status: Not yet recruiting
• Conditions: Stage III Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Frederike Bensch, MD, PhD; Phone Number: 0031503610280; Email: f.bensch@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Eligibility for adjuvant durvalumab per standard of care.
• At least one tumor lesion or involved lymph node accessible by bronchoscopy or endoscop-ic/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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT at dose of 15 mg; Patients will receive an intravenous administration of 15 mg durvalumab-680LT before the bronchoscopy procedure. The bronchoscopy will start with high-definition white light bronchoscopy, followed by fluorescence molecular bronchoscoy to observe the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluores-cence signal in vivo.	Drug: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT; Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
Experimental: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT at dose of 25 mg; Patients will receive an intravenous administration of 25 mg durvalumab-680LT before the bronchoscopy procedure. The bronchoscopy will start with high-definition white light bronchoscopy, followed by fluorescence molecular bronchoscoy to observe the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluores-cence signal in vivo.	Drug: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT; Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In vivo fluorescent signal of malignant lesions (pulmonary nodule or involved lymph node metastasis)	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. (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.)	Assessed directly during the bronchoscopy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of fluorescence signal with IHC	In vivo and ex vivo fluorescence signal, PD-L1 IHC score (assessed according to standard pathology protocols).	Up to 2 years
Correlation of fluorescence signal with EFS	In vivo and ex vivo fluorescence signal, 1-, 2-and 5-year (long-term exploratory endpoint) event-free survival.	Up to 2 years
Safety of single durvalumab-680LT injection	Adverse events according to CTCAE v5.0	Within 1 week after tracer injection
Comparison of the 15 and 25 mg dose durvalumab-680LT	in vivo tumor-to-background ratio of 15 mg versus 25 mg	Assessed directly during the bronchoscopy procedure

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Near-infrared fluorescence imaging; Fluorescence molecular bronchoscopy; Durvalumab-680LT
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 24296; 2026-526251-60-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No