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Study of IPH5201 and Durvalumab for Pre- and Post-Surgery Treatment in Patients with Early-Stage Non-Small Cell Lung Cancer

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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 treatments for , a type of lung cancer that is common and can be serious. The study involves two main treatments: and (also known as ). These treatments are given to patients before and after surgery to see how well they work in reducing the cancer. The purpose of the study is to assess the effectiveness and safety of these treatments in patients with early-stage lung cancer that can be surgically removed.

Participants in the study will receive the treatments through an intravenous infusion, which means the medicine is given directly into a vein. The study will take place over a period of up to 12 months. During this time, doctors will monitor the patients to see how the cancer responds to the treatment and to check for any side effects. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The study aims to find out if the treatments can help achieve a complete response, meaning no cancer cells are found after surgery. It will also look at how long patients remain free of cancer after treatment and surgery. The results will help determine if these treatments can be a safe and effective option for people with early-stage .

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

    Neoadjuvant treatment

    The initial phase involves the administration of medications before surgery. This is known as neoadjuvant treatment.

    You will receive two medications: IPH5201 and durvalumab. Both are given through a vein, a method called intravenous administration.

    The goal of this phase is to reduce the size of the tumor and assess the response to the treatment.

  2. Step 2

    Surgery

    After completing the neoadjuvant treatment, surgery will be performed to remove the lung cancer.

    The type of surgery will depend on the specific characteristics of your condition and may include procedures like lobectomy or sleeve resection.

    The surgery aims to remove all visible cancer.

  3. Step 3

    Adjuvant treatment

    Following surgery, adjuvant treatment is administered to eliminate any remaining cancer cells and reduce the risk of cancer returning.

    This phase involves the continued use of durvalumab, administered intravenously.

    The duration and frequency of this treatment will be determined based on your individual response and overall health.

  4. Step 4

    Follow-up

    Regular follow-up appointments will be scheduled to monitor your recovery and check for any signs of cancer recurrence.

    These appointments may include physical exams, imaging tests, and laboratory tests.

    The follow-up phase is crucial for ensuring long-term health and managing any potential side effects of the treatment.

Who can join the trial?

14 criteria

  • Must be able to give signed permission to participate, agreeing to follow the study's rules and requirements.
  • Must be at least 18 years old.
  • Must have been newly diagnosed with **Non-Small Cell Lung Cancer** (NSCLC) and not have received any treatment for it before.
  • The cancer must be in a stage that can be surgically removed, specifically Stage IIA to Stage IIIA.
  • Must be a candidate for specific types of lung surgery: lobectomy, sleeve resection, or bilobectomy.
  • Must have a **WHO Performance Status** or **ECOG Performance Status** of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
  • Must have adequate organ and bone marrow function, which includes having enough red blood cells, white blood cells, and platelets, and normal liver and kidney function.
  • Must have a life expectancy of at least 12 weeks.
  • Must weigh more than 35 kg (about 77 pounds).
  • Both men and women can participate.
  • Women who can have children must have a negative pregnancy test.
  • Must provide a sample of the tumor for testing specific markers like **PD-L1**, **EGFR**, or **ALK**.
  • Must provide a tumor sample for additional research purposes.
  • Must be eligible for surgery, with specific lung function tests showing a certain level of lung capacity.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer besides Non-Small Cell Lung Cancer stages II, III, or IIIA cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to safely undergo surgery cannot participate.
  • Patients with serious health conditions that could interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have received certain treatments recently that could affect the study cannot participate.
  • Patients who are unable to follow the study procedures cannot participate.
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Investigated drugs

  • IPH5201

    is an investigational medication being studied for its potential to help the immune system fight cancer. It is used in this trial as a treatment before and after surgery to see if it can improve outcomes for patients with early-stage non-small cell lung cancer.

  • Durvalumab

    is a medication that helps the immune system attack cancer cells. It is used in this trial to see if it can enhance the body's immune response against lung cancer when given before and after surgery.

What is already known about the treatment

  • IPH5201

    This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating early-stage non-small cell lung cancer. It is in the experimental phase and not yet widely recognized in medical literature. The main therapeutic indication is for use as a neoadjuvant and adjuvant treatment in patients with resectable lung cancer. At the molecular level, IPH5201 works by targeting specific proteins involved in tumor growth, aiming to enhance the body's immune response against cancer cells. It is classified as an immunotherapy agent.

  • Durvalumab

    This medication is also administered intravenously and is approved for use in certain types of cancer, including non-small cell lung cancer. It is well-documented in medical literature and is used to help the immune system detect and fight cancer cells. The main therapeutic indication is for use in combination with other treatments for resectable lung cancer. Durvalumab works by blocking a protein that prevents the immune system from attacking cancer cells, thereby enhancing the immune response. It is classified as a monoclonal antibody and an immune checkpoint inhibitor.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms like persistent cough, chest pain, and shortness of breath may occur. The progression of the disease is categorized into stages, with stages II, III, and IIIA indicating more advanced disease where the cancer has spread to nearby lymph nodes or other areas within the chest. The progression and impact on the body can vary based on the specific subtype and stage of the cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507778-42-00Protocol codeIPH5201-201Estimated enrolment70 patientsSponsorInnate Pharma

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