Stage III Non-small Cell Lung Cancer, Unresectable Stage III NSCLC
Conditions
Keywords
Fluorescence molecular bronchoscopy, Durvalumab-680LT, Near-infrared fluorescence imaging
Brief 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. 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
DRUGFluorescence molecular imaging during bronchoscopy with durvalumab-680LT
Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
Sponsors
University Medical Center Groningen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In vivo fluorescence signal of malignant lesions (pulmonary nodule and/or involved lymph node metastases) | 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
| Measure | Time frame | Description |
|---|---|---|
| Correlation of fluorescence signal with immunohistochemistry (IHC) | 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). |
| Correlation of fluorescence signal with event-free survival (EFS) | Up to 2 years | In vivo and ex vivo fluorescence signal, 1-, 2-and 5-year (long-term exploratory endpoint) event-free survival (EFS). |
| Incidence of adverse events after single durvalumab-680LT injection | Within 1 week after tracer injection | Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| Comparison of the 15 and 25 mg dose durvalumab-680LT | Assessed directly during the bronchoscopy procedure | in vivo tumor-to-background ratio of 15 mg versus 25 mg |
Contacts
CONTACTFrederike Bensch, MD, PhD
Outcome results
None listed