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NCT Number: NCT07653438

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

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.

Treatment and study plan

Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT

Drug

Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT

Primary outcomes

  1. In vivo fluorescence signal of malignant lesions (pulmonary nodule and/or involved lymph node metastases)

    Time frame: Assessed directly during the bronchoscopy procedure

    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.)

Secondary outcomes

  1. Correlation of fluorescence signal with immunohistochemistry (IHC)

    Time frame: Up to 2 years

    In vivo and ex vivo fluorescence signal, programmed-death ligand 1 (PD-L1) immunohistochemistry (IHC) score (assessed according to standard pathology protocols).

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

    Time frame: Up to 2 years

    In vivo and ex vivo fluorescence signal, 1-, 2-and 5-year (long-term exploratory endpoint) event-free survival (EFS).

  3. Incidence of adverse events after single durvalumab-680LT injection

    Time frame: Within 1 week after tracer injection

    Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0

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

    Time frame: Assessed directly during the bronchoscopy procedure

    in vivo tumor-to-background ratio of 15 mg versus 25 mg

Study contacts

Contact information is provided by the study sponsor or research team.

Frederike Bensch, MD, PhD

CONTACT

[email protected]

0031503610280

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: PulmoPrint

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Jun 17, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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