Stage III Non-small Cell Lung CancerPhase 2PulmoPrintNCT07653438
In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy
A Phase 2 study testing Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT in people with Stage III Non-small Cell Lung Cancer and Unresectable Stage III NSCLC, run by University Medical Center Groningen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Non-small Cell Lung Cancer, Unresectable Stage III NSCLC
- What is being tested?
- Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Mar 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
- Keywords
- Fluorescence molecular bronchoscopy, Durvalumab-680LT, Near-infrared fluorescence imaging
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence molecular imaging during bronchoscopy with durvalumab-680LTDrug
Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: Assessed directly during the bronchoscopy procedure
Secondary outcomes (4)
Correlation of fluorescence signal with immunohistochemistry (IHC)
In vivo and ex vivo fluorescence signal, programmed-death ligand 1 (PD-L1) immunohistochemistry (IHC) score (assessed according to standard pathology protocols).
Measured: Up to 2 years
Correlation of fluorescence signal with event-free survival (EFS)
In vivo and ex vivo fluorescence signal, 1-, 2-and 5-year (long-term exploratory endpoint) event-free survival (EFS).
Measured: Up to 2 years
Incidence of adverse events after single durvalumab-680LT injection
Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 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
Measured: Assessed directly during the bronchoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653438
- Sponsor's protocol ID
- 24296
- Other IDs
- 2026-526251-60-00
- Acronym
- PulmoPrint
- Status last verified
- Jul 2026
- First submitted
- 11 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No