In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy (PulmoPrint)
13. juli 2026 opdateret af: University Medical Center Groningen
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
20
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Frederike Bensch, MD, PhD
- Telefonnummer: 0031503610280
- E-mail: f.bensch@umcg.nl
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 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 |
Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
|
|
Eksperimentel: 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 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 |
Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
In vivo fluorescence signal of malignant lesions (pulmonary nodule and/or involved lymph node metastases)
Tidsramme: 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.)
|
Assessed directly during the bronchoscopy procedure
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of the 15 and 25 mg dose durvalumab-680LT
Tidsramme: Assessed directly during the bronchoscopy procedure
|
in vivo tumor-to-background ratio of 15 mg versus 25 mg
|
Assessed directly during the bronchoscopy procedure
|
|
Correlation of fluorescence signal with immunohistochemistry (IHC)
Tidsramme: 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).
|
Up to 2 years
|
|
Correlation of fluorescence signal with event-free survival (EFS)
Tidsramme: Up to 2 years
|
In vivo and ex vivo fluorescence signal, 1-, 2-and 5-year (long-term exploratory endpoint) event-free survival (EFS).
|
Up to 2 years
|
|
Incidence of adverse events after single durvalumab-680LT injection
Tidsramme: Within 1 week after tracer injection
|
Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
|
Within 1 week after tracer injection
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. marts 2028
Studieafslutning (Anslået)
1. marts 2031
Datoer for studieregistrering
Først indsendt
11. juni 2026
Først indsendt, der opfyldte QC-kriterier
11. juni 2026
Først opslået (Faktiske)
17. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 24296
- 2026-526251-60-00 (Ctis)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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