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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07653438). StuddyBuddy aggregates publicly available trial information.