- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07653438
In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy (PulmoPrint)
In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy - PulmoPrint
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Frederike Bensch, MD, PhD
- Telefonnummer: 0031503610280
- E-post: f.bensch@umcg.nl
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 24296
- 2026-526251-60-00 (Ctis)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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