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Not yet recruiting NCT07653438

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

Phase II Interventional Stage III Non-small Cell Lung Cancer Unresectable Stage III NSCLC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT.
Who it may be relevant to
Registry conditions: Stage III Non-small Cell Lung Cancer, Unresectable Stage III NSCLC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • In vivo fluorescence signal of malignant lesions (pulmonary nodule and/or involved lymph node metastases) [Time frame: Assessed directly during the bronchoscopy procedure]
Secondary outcome measures (4)
  • Correlation of fluorescence signal with immunohistochemistry (IHC) [Time frame: Up to 2 years]
  • Correlation of fluorescence signal with event-free survival (EFS) [Time frame: Up to 2 years]
  • Incidence of adverse events after single durvalumab-680LT injection [Time frame: Within 1 week after tracer injection]
  • Comparison of the 15 and 25 mg dose durvalumab-680LT [Time frame: Assessed directly during the bronchoscopy procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07653438 · 24296 · 2026-526251-60-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗