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

NCT07653438 | Not Yet Recruiting Phase 2

• 2 other identifiers: 242962026-526251-60-00
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stage III Non-small Cell Lung Cancer; Unresectable Stage III NSCLC

Keywords

Fluorescence molecular bronchoscopy; Durvalumab-680LT; Near-infrared fluorescence imaging

Outcome Measures

Primary Outcomes (1)

• 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.)

  Assessed directly during the bronchoscopy procedure

Secondary Outcomes (4)

• Correlation of fluorescence signal with immunohistochemistry (IHC)

  Up to 2 years

• Correlation of fluorescence signal with event-free survival (EFS)

  Up to 2 years

• Incidence of adverse events after single durvalumab-680LT injection

  Within 1 week after tracer injection

• Comparison of the 15 and 25 mg dose durvalumab-680LT

  Assessed directly during the bronchoscopy procedure

Study Arms (2)

Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT at dose of 15 mg

EXPERIMENTAL

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 bronchoscopy to visualize the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluorescence signal in vivo. \* MDSFR, multi-diameter single-fiber reflectance spectroscopy; SFF, single-fiber fluorescence spectroscopy

Drug: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT

Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT at dose of 25 mg

EXPERIMENTAL

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 bronchoscopy to visualize the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluorescence signal in vivo. \* MDSFR, multi-diameter single-fiber reflectance spectroscopy; SFF, single-fiber fluorescence spectroscopy

Drug: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT

Interventions

Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT DRUG

Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT

Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT at dose of 15 mg; Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT at dose of 25 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Frederike Bensch, MD, PhD

CONTACT

0031503610280; f.bensch@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2031
• Last Updated: July 15, 2026

Record last verified: 2026-07