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NCT07653438
In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy
Conditions: Stage III Non-small Cell Lung Cancer, Unresectable Stage III NSCLC
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 20
Sponsor: University Medical Center Groningen
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.
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.
Source: ClinicalTrials.gov (NCT07653438). StuddyBuddy aggregates publicly available trial information.