In-vivo Fluorescence Molecular Bronchoscopy of Dur-valumab-680LT in Patients With Unresectable St… (NCT07653438) | Clinical Trial Compass
Not Yet RecruitingPhase 2
In-vivo Fluorescence Molecular Bronchoscopy of Dur-valumab-680LT in Patients With Unresectable Stage III NSCLC After Chemoradiation
20 participantsStarted 2026-09-01
Plain-language summary
PulmoPrint is a clinical study at UMCG that investigates why some patients with unresectable stage III lung cancer stop responding to immunotherapy after chemoradiation. To do this, a small dose of a fluorescently labeled version of the immunotherapy drug durvalumab is given via an IV drip, after which a camera bronchoscopy is performed to visualize where and how much of the drug actually reaches the tumor and lymph nodes - before the actual durvalumab treatment starts.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent prior to participation in the study.
* Age ≥ 18 years.
* Histologically or cytologically confirmed unresectable stage III NSCLC.
* Completion of concurrent platinum-based CRT
* Eligibility for adjuvant durvalumab per standard of care.
* At least one tumor lesion or involved lymph node accessible by bronchoscopy or endoscop-ic/endobronchial ultrasound, suitable for biopsy/FNA and fluorescence measurement.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a specially labeled version of durvalumab called Dur-valumab-680LT to light up tumor cells during a bronchoscopy — how does attaching that fluorescent label compare to the standard durvalumab I might already be receiving, and could participating affect my regular treatment plan?
2Since this is a Phase 2 trial that hasn't started enrolling yet, what does that mean for how much is already known about the safety of this fluorescent imaging approach in people with Stage III non-small cell lung cancer?
3The trial involves a bronchoscopy procedure to detect fluorescent signals in lung nodules or lymph nodes — given my specific situation, how would you weigh the risks of that additional procedure against any potential benefit of this type of imaging?
4Because this study is still listed as 'not yet recruiting,' how long might it realistically be before it opens and I could even be considered, and would waiting affect my other treatment options like standard chemoradiation or durvalumab maintenance?
5If the goal here is improving how doctors can see and track tumors during bronchoscopy, would my care team gain information from this trial that could directly influence decisions about my treatment, or is this primarily helping future patients?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
In vivo fluorescent signal of malignant lesions (pulmonary nodule or involved lymph node metastasis)
Timeframe: Assessed directly during the bronchoscopy procedure