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Study for Patients with Lung or Urinary Tract Cancer Continuing Treatment with Durvalumab, Infliximab, and Mycophenolate Mofetil

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

This clinical trial is focused on patients with certain types of cancer, including Locally Advanced, Unresectable Non-Small Cell Lung Cancer, Post-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract, Advanced or Metastatic Non-Small Cell Lung Cancer in patients who have not received prior treatment, and First-line Extensive Disease Small-Cell Lung Cancer. The study involves the use of a medication called Durvalumab, also known by its code name MEDI4736. This medication is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to continue providing treatment to patients who have completed a previous cancer study with Durvalumab and are still benefiting from it, according to their doctor. The study will monitor the safety and how well patients tolerate the treatment. In addition to Durvalumab, the study may also involve other medications such as Infliximab and Mycophenolate Mofetil, which are used for different purposes. Infliximab is administered through an infusion, while Mycophenolate Mofetil is taken orally in capsule form.

Participants in this study will continue to receive their treatment as long as they are benefiting from it. The study will keep track of any serious side effects that occur up to 90 days after the last dose of the study treatment. This trial aims to ensure that patients who are doing well on their current treatment can continue to receive it safely.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must provide a signed and dated informed consent form (ICF). This document confirms the patient's understanding and agreement to participate in the study.

    The patient must be currently benefiting from a previous study involving an AstraZeneca (AZ) compound and must be eligible to continue treatment with durvalumab.

  2. Step 2

    Treatment administration

    The patient will receive durvalumab as a fixed dose of 1500 mg every four weeks (Q4W).

    The administration of durvalumab is done through intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein.

  3. Step 3

    Monitoring and safety

    Throughout the study, the patient's safety and the tolerability of the treatment will be closely monitored.

    Any serious adverse events (SAEs) will be reported and monitored for up to 90 days after the last dose of the study treatment.

  4. Step 4

    Study duration

    The study is designed to continue providing treatment to patients who benefit from it until the estimated end date of May 8, 2025.

    The study aims to ensure that patients who have completed a previous oncology study with durvalumab can continue to receive treatment if they are still benefiting from it.

Who can join the trial?

5 criteria

  • The patient must provide a signed and dated written document called an Informed Consent Form (ICF), which shows they agree to participate in the study.
  • The patient should currently be benefiting from a treatment in a previous study, as determined by the study doctor. This means the treatment is helping them, and they are using a specific medicine from the previous study that has either finished or reached the maximum time allowed.
  • The patient must be able to receive a medicine called durvalumab at a fixed dose of 1500 mg every four weeks when they start the study.
  • Both male and female patients can participate in the study.
  • The study includes patients who might be considered part of a vulnerable population, meaning they may need extra care or protection.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not part of the study.
  • Patients who have not completed previous treatments required by the study.
  • Patients with medical conditions that could interfere with the study treatment.
  • Patients who are unable to follow the study procedures or attend required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients with severe allergies or reactions to the study medication.
  • Patients with serious infections or illnesses that could affect their participation.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of substance abuse that could interfere with the study.
  • Patients who have had a recent major surgery that could impact their health during the study.
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Investigated drugs

Durvalumab is a medication used in this clinical trial. It is an immunotherapy drug that helps the body's immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. This allows the immune system to better recognize and destroy cancer cells. In this trial, patients who have previously benefited from durvalumab in another study will continue to receive it to see if it continues to help them.

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently recognized in medical literature as an immunotherapy drug used in the treatment of certain types of cancer, including non-small cell lung cancer and urothelial carcinoma. The main therapeutic indications for Durvalumab include locally advanced, unresectable non-small cell lung cancer, post-chemotherapy urothelial carcinoma, and advanced or metastatic non-small cell lung cancer in treatment-naive patients. At the molecular level, Durvalumab works by blocking the PD-L1 protein on cancer cells, which helps the immune system recognize and attack these cells more effectively. It is classified pharmacologically as a monoclonal antibody and is part of a class of drugs known as immune checkpoint inhibitors.

Investigated diseases

  • Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III)

    This is a type of lung cancer where the tumor has spread to nearby tissues or lymph nodes but cannot be surgically removed. It is not yet spread to distant parts of the body. The disease often causes symptoms like persistent cough, chest pain, and difficulty breathing. As it progresses, it may lead to more severe respiratory issues and general weakness.

  • Post-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract

    This condition refers to cancer that affects the urinary tract, including the bladder, ureters, and kidneys, after chemotherapy treatment. Urothelial carcinoma is the most common type, but non-urothelial types can also occur. The disease may cause symptoms such as blood in the urine, frequent urination, and pain during urination. Over time, it can lead to more severe urinary problems and discomfort.

  • Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) in Treatment Naive Patients with Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) Wild Type Tumour Pathology

    This form of lung cancer is characterized by its spread beyond the lungs in patients who have not received prior treatment. The tumors do not have mutations in the EGFR or ALK genes. Symptoms may include persistent cough, weight loss, and fatigue. As the disease advances, it can lead to more significant respiratory and systemic issues.

  • First-line Patients with Extensive Disease (Stage IV) Small-Cell Lung Cancer (SCLC)

    This is an aggressive form of lung cancer that has spread widely throughout the body. It is often diagnosed at an advanced stage due to its rapid progression. Common symptoms include coughing, chest pain, and shortness of breath. As the disease progresses, it can cause significant health deterioration and impact various bodily functions.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507337-22-00Protocol codeD4191C00137 ROSY-DEstimated enrolment229 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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