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Study on Durvalumab and Stereotactic Body Radiotherapy for Patients with Early-Stage Non-Small Cell Lung Cancer

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 studying Non-small Cell Lung Cancer (NSCLC), a common type of lung cancer. The treatment being tested is called Durvalumab, also known by its code name MEDI4736. Durvalumab is a type of medication known as an immunotherapy, which helps the body's immune system fight cancer. In this study, Durvalumab is given to patients after they have received a specific type of radiation therapy called Stereotactic Body Radiotherapy (SBRT). This radiation therapy is designed to target and destroy cancer cells in a precise manner.

The purpose of the study is to see if using Durvalumab after SBRT can help increase the time it takes for the cancer to progress or worsen. Patients participating in the study will receive Durvalumab through an infusion, which means the medication is delivered directly into the bloodstream. The study will follow patients over a period of time to monitor their response to the treatment and any changes in their condition.

Throughout the study, patients will have regular visits and examinations to track their health and the effects of the treatment. The goal is to gather information on how well Durvalumab works in combination with SBRT for treating early-stage NSCLC, specifically in patients who are not able to undergo surgery or choose not to have surgery. This research aims to provide insights into improving treatment options for individuals with this type of lung cancer.

The research process

The trial runs in 5 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 written informed consent. This is a formal agreement to participate in the trial after understanding all the procedures and potential risks involved.

    Female patients of childbearing potential must confirm their post-menopausal status or provide a negative pregnancy test result.

  2. Step 2

    Initial assessment

    The patient undergoes an initial assessment to confirm eligibility. This includes verifying a diagnosis of non-small cell lung cancer (NSCLC) with specific tumor characteristics (T1-2N0M0, tumors ≤ 5 cm, peripheral location).

    The patient must not have received prior chemotherapy or radiation therapy for NSCLC and should be medically inoperable or refuse surgery.

  3. Step 3

    Stereotactic body radiotherapy (SBRT)

    The patient receives stereotactic body radiotherapy (SBRT), a precise form of radiation therapy aimed at the tumor.

  4. Step 4

    Administration of durvalumab

    Following SBRT, the patient receives durvalumab, an immunotherapy medication. Durvalumab is administered as an infusion, which means it is given directly into the bloodstream through a vein.

    The specific dosage and frequency of durvalumab administration are determined by the study protocol and the patient's condition.

  5. Step 5

    Monitoring and follow-up

    The patient attends scheduled visits and examinations to monitor their health and the effectiveness of the treatment.

    The primary goal is to assess the time to progression (TTP), which is the duration before the cancer shows signs of growth or spread.

Who can join the trial?

11 criteria

  • The patient must provide written informed consent before any study-related procedures are done.
  • For women, there must be proof of being post-menopausal or a negative pregnancy test if they are pre-menopausal. Post-menopausal means not having a menstrual period for 12 months without another medical reason.
  • The patient must be willing and able to follow the study rules, including attending treatment sessions, visits, and exams.
  • The patient must have a confirmed diagnosis of **non-small cell lung cancer (NSCLC)**, which is a type of lung cancer.
  • The cancer tumors must be **T1-2N0M0**, meaning they are small (5 cm or less) and have not spread to lymph nodes or other parts of the body.
  • The tumors must be located in the outer areas of the lungs, known as peripheral tumors.
  • The patient must be unable to have surgery for medical reasons, be at risk if they have surgery, or choose not to have surgery.
  • The patient must not have received any previous chemotherapy or radiation therapy for NSCLC.
  • The patient must be over 18 years old, with no upper age limit.
  • The patient must have a **WHO performance status** of 0-2, which measures their ability to perform daily activities.
  • The patient must have normal organ and bone marrow function, which includes specific levels of blood cells and other substances in the body.

Who cannot join the trial?

5 criteria

  • Patients with other types of cancer besides non-small cell lung cancer (NSCLC) cannot participate. NSCLC is a type of lung cancer.
  • Patients who have not received curatively intended SBRT are excluded. SBRT stands for Stereotactic Body Radiation Therapy, a precise and high-dose radiation treatment aimed at curing the cancer.
  • Patients with cancer that has spread to other parts of the body (beyond T1-2N0M0 stage) are not eligible. T1-2N0M0 describes a specific stage of cancer where the tumor is small and has not spread to lymph nodes or other organs.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups only.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
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Investigated drugs

  • Durvalumab

    is an immunotherapy medication used in this trial. It is designed to help the body's immune system recognize and attack cancer cells. In this study, it is given to patients after they have received a type of precise radiation therapy called Stereotactic Body Radiotherapy (SBRT) to see if it can help delay the progression of non-small cell lung cancer.

  • Stereotactic Body Radiotherapy (SBRT)

    is a form of radiation therapy that delivers highly focused beams of radiation to a tumor. It is used in this trial to treat patients with early-stage non-small cell lung cancer. The goal is to target the cancer cells with minimal damage to the surrounding healthy tissue.

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 being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC), particularly following stereotactic body radiotherapy (SBRT). The main therapeutic indication for durvalumab is to enhance the immune system's ability to fight cancer by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. This medication is classified as an immunotherapy, specifically a PD-L1 inhibitor, and is being evaluated for its potential to increase the time to progression in patients with early-stage NSCLC.

Investigated diseases

Non-small cell lung cancer (NSCLC) – This is the most common type of lung cancer, accounting for about 85% of all cases. It typically starts in the epithelial cells lining the lungs and can grow and spread to other parts of the body. NSCLC progresses through stages, beginning with localized tumors and potentially advancing to involve nearby lymph nodes and distant organs. The disease is often categorized into subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, based on the cells involved. Symptoms may include a persistent cough, chest pain, and shortness of breath, but they often appear only after the disease has advanced. Early detection is challenging, as initial stages may not present noticeable symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512439-54-01Estimated enrolment106 patientsSponsorVaestra Goetalandsregionen

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