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Fluorescence bronchoscopy to assess durvalumab-680LT distribution in unresectable stage III non‑small cell lung cancer patients after chemoradiation

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients with unresectable stage III non‑small cell lung cancer, a form of lung cancer that cannot be removed by surgery and is at an advanced stage. The investigational treatment is a version of the immunotherapy drug durvalumab that has been attached to a fluorescent marker and is referred to as durvalumab‑680LT. This drug is given by an intravenous (IV) infusion, meaning it is delivered through a needle placed in a vein. All participants also receive standard chemoradiation, which is a combination of chemotherapy drugs and radiation therapy used to shrink the tumor before the new drug is examined.

The purpose of the study is to see how the fluorescent drug spreads inside the tumor and nearby lymph nodes after chemoradiation but before regular durvalumab treatment begins. Participants undergo a procedure called fluorescence molecular bronchoscopy, where a thin, flexible tube with a special camera is inserted through the airway to look directly at the lungs and lymph nodes. The camera detects the glow from the drug, and the brightness is expressed as a tumor‑to‑background ratio, a simple number that compares how bright the tumor appears to the surrounding tissue; a higher number indicates better drug presence in the tumor.

After the bronchoscopy, patients are monitored for any side effects and have routine follow‑up visits to track their health over time. No additional experimental treatments are given beyond the standard care and the single imaging procedure. The information collected will help researchers understand where the drug goes in the body, which may guide future use of immunotherapy for this type of lung cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After joining the study, you sign an informed consent form that explains the purpose and procedures. this records you as a participant in the trial.

  2. Step 2

    Baseline assessment and scheduling

    The study team performs basic health checks, such as blood tests and a review of your recent chemoradiation treatment. they then arrange a date for the imaging procedure, usually within a few weeks after chemoradiation.

  3. Step 3

    Administration of the imaging agent

    On the day of the procedure you receive a single dose of durvalumab-680lt (25 mg) by intravenous infusion. the medication is delivered through a vein over a short period, similar to a routine drip.

  4. Step 4

    Fluorescence bronchoscopy

    A thin, flexible tube with a tiny camera (a bronchoscope) is gently inserted through your mouth into the airways. the fluorescence bronchoscopy uses special light that makes the cancer cells glow because of the imaging agent. this allows doctors to see the tumor and any involved lymph nodes and to measure how bright the signal is compared with surrounding tissue.

  5. Step 5

    Image and data collection

    During the bronchoscopy, images and spectroscopic measurements are recorded. the brightness of the signal is expressed as a tumor‑to‑background ratio; a ratio greater than 2 is considered sufficient. any tissue that is removed for analysis is also examined in the laboratory.

  6. Step 6

    Safety monitoring after the procedure

    After the infusion and bronchoscopy you are observed for possible side effects. follow‑up visits are scheduled to check for any adverse events, which are graded using the standard ctcae v5.0 system (a scale that classifies the severity of side effects).

  7. Step 7

    Transition to standard durvalumab therapy

    Once the imaging study is completed and safety checks are finished, you may start regular durvalumab treatment as part of standard care. this step is separate from the imaging portion of the trial.

Who can join the trial?

8 criteria

  • You have signed an informed consent form showing that you agree to join the study.
  • You are 18 years old or older.
  • Your lung cancer has been confirmed by looking at tissue or cells under a microscope, and it is stage III non‑small cell lung cancer that cannot be removed by surgery.
  • You have finished a combined chemotherapy and radiation treatment that uses a platinum‑based CRT (chemoradiation therapy), with the radiation given at the University Medical Center Groningen.
  • You are eligible to receive durvalumab, a medication given after the main treatment to help keep the cancer from returning, as it is normally used.
  • There is at least one tumor spot or affected lymph node that can be reached with a thin tube (bronchoscopy) or an ultrasound probe inserted into the airway (endobronchial ultrasound), and a small tissue sample can be taken for testing.
  • Your overall level of activity and ability to care for yourself is rated from 0 (fully active) to 2 (up and about more than half of the day), and you fall within this range (ECOG performance status 0–2).
  • You are considered healthy enough to undergo a research bronchoscopy (with or without the ultrasound probe), and you may receive a mild sedative called propofol or general anesthesia if needed.

Who cannot join the trial?

5 criteria

  • You cannot join if you have ever had an allergic‑type reaction called an infusion reaction to the drug durvalumab, other medicines that target PD‑L1, or any other lab‑made protein called a monoclonal antibody.
  • You cannot join if your doctor says you should not have a bronchoscopy (a test that looks inside the lungs with a thin tube) or an endoscopic/endobronchial ultrasound (a test that uses sound waves through a tube), especially if you have a serious bleeding problem called coagulopathy that cannot be fixed, very poor breathing ability called respiratory insufficiency, or any other reason the doctor decides.
  • You cannot join if you have a medical or mental health condition that makes it hard for you to understand the study and give your permission, known as informed consent.
  • You cannot join if you are pregnant or breastfeeding, and women who could become pregnant must have a negative pregnancy test on the day the study drug is given.
  • You cannot join if you have taken another experimental medicine, called an investigational medicinal product, within the 30 days before receiving the study drug, referred to as the tracer.
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Investigated drugs

  • Durvalumab (IMFINZI)

    is an immunotherapy medicine given by a drip into a vein. It works by helping the body’s immune system recognize and attack lung cancer cells. In this trial, patients receive durvalumab after they have finished chemotherapy and radiation, and the drug is part of the standard treatment plan for unresectable stage III non‑small cell lung cancer.

  • Durvalumab‑680LT

    is a special version of durvalumab that has a fluorescent tag attached. This tag makes the drug glow under a special light, allowing doctors to see where the medicine goes inside the lungs and nearby lymph nodes. The purpose of using this labeled drug is to study its distribution in the tumor area before the regular durvalumab treatment starts.

  • Fluorescence molecular bronchoscopy

    is a procedure where a thin, flexible tube with a tiny camera and a light source is passed through the airway to look directly at the lungs. With the fluorescent tag on durvalumab‑680LT, the camera can detect glowing areas, helping researchers see how the drug spreads in the tumor and lymph nodes. This imaging technique is used in the study to gather detailed information about drug delivery without needing surgery.

What is already known about the treatment

Durvalumab - This medication is given by intravenous infusion, where a liquid solution is slowly injected into a vein. It is an approved drug that is widely used and described in medical research for treating certain lung cancers and other solid tumors. Durvalumab works by attaching to a protein called PD‑L1 on cancer cells, stopping it from turning off the body's immune response, so the immune system can better attack the tumor. It belongs to the class of immune checkpoint inhibitors, which are a type of monoclonal antibody therapy.

Investigated diseases

Unresectable stage III non‑small cell lung cancer - It is a type of lung cancer that originates from the larger airway cells and lacks the small cells seen in other lung cancers. At stage III, the tumor has extended into nearby tissues or lymph nodes but has not yet reached distant organs. Because the tumor cannot be safely removed with surgery, it is described as unresectable. The disease tends to grow within the chest, involving surrounding lung tissue, the chest wall, or mediastinal lymph nodes. With time it may progress to involve distant sites, known as metastatic spread.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526251-60-00Estimated enrolment20 patientsSponsorUniversitair Medisch Centrum Groningen

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