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Study of Volrustomig and Drug Combination for Patients with Early-stage Resectable 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 Non-small Cell Lung Cancer (NSCLC), specifically in its early stages where the cancer can be surgically removed. The study involves several medications, including volrustomig (also known as MEDI5752), carboplatin, AZD0171 (also known as falbikitug), paclitaxel, datopotamab deruxtecan (also known as DS-1062a or Dato-DXd), pemetrexed, cisplatin, durvalumab (also known as MEDI4736 or IMFINZI™), oleclumab (also known as MEDI9447), and monalizumab (also known as IPH2201). These treatments are given as solutions for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the effectiveness and safety of these treatments when given before and after surgery. The study will follow a course where patients receive the treatments before surgery to shrink the tumor, known as neoadjuvant treatment, and then continue with additional treatments after surgery, known as adjuvant treatment. The study aims to see how well these treatments work in reducing the cancer and how safe they are for patients.

Participants in the study will receive either the active medications or a placebo. The study will monitor the response of the cancer to the treatments, as well as any side effects experienced by the participants. The goal is to gather information that could help improve treatment options for patients with early-stage NSCLC that can be surgically removed.

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, eligibility is confirmed based on specific criteria such as having resectable non-small cell lung cancer (NSCLC) at stages IIA to IIIB, adequate organ function, and a performance status of 0 or 1.

    Tumor samples are required to confirm specific cancer markers.

  2. Step 2

    Neoadjuvant treatment

    Neoadjuvant treatment involves administering medications before surgery to reduce the size of the tumor.

    Medications include volrustomig, carboplatin, falbikitug, paclitaxel, datopotamab deruxtecan, cisplatin, durvalumab, oleclumab, and monalizumab, all given through intravenous infusion.

    The goal is to assess the reduction of viable tumor cells.

  3. Step 3

    Surgery

    Surgery is planned to occur within 40 days after the last dose of neoadjuvant treatment.

    The aim is to remove the tumor and assess the presence of any remaining cancer cells.

  4. Step 4

    Adjuvant treatment

    Adjuvant treatment is administered after surgery to eliminate any remaining cancer cells and reduce the risk of recurrence.

    The same medications used in the neoadjuvant phase may be continued, depending on individual response and tolerance.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up visits are scheduled to monitor health status, check for any side effects, and assess the effectiveness of the treatment.

    This phase includes evaluating vital signs, laboratory tests, and imaging studies to ensure safety and track progress.

Who can join the trial?

6 criteria

  • Patients must have been newly diagnosed with a type of lung cancer called **Non-small Cell Lung Cancer (NSCLC)** that can be surgically removed. The cancer should be in an early stage, specifically from Stage IIA to Stage IIIB.
  • Patients should have a **performance status** of 0 or 1 according to the **WHO** or **Eastern Cooperative Oncology Group (ECOG)** scale. This means they should be fully active or have some symptoms but still be able to carry out light work.
  • Patients need to have **adequate organ and bone marrow function**, which means their organs and bone marrow are working well enough to handle the treatment.
  • Patients must provide samples of their tumor, either newly taken or from the last 6 months, to check for specific markers like **Programmed death-ligand 1 (PD-L1)**, **epidermal growth factor receptor (EGFR)**, or **anaplastic lymphoma kinase (ALK)**. These are proteins or genes that can affect how the cancer behaves and responds to treatment.
  • Patients should have **adequate pulmonary function**, meaning their lungs should be working well enough to handle the treatment and surgery.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer that are not **Non-small Cell Lung Cancer**.
  • Patients with lung cancer that is not in the **early stages** (II to IIIB).
  • Patients whose lung cancer cannot be **surgically removed** (resectable).
  • Patients who have received other treatments for lung cancer before the study.
  • Patients with serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

  • Tremelimumab

    is another medication in the trial that helps boost the immune system's response against cancer. It works by targeting a specific protein that can suppress the immune system, thereby enhancing the body's ability to fight cancer cells.

  • Oleclumab

    is included in the trial to target and block a protein that is involved in the growth and spread of cancer cells. By inhibiting this protein, the medication aims to slow down or stop the progression of the cancer.

  • Monalizumab

    is used in the trial to enhance the immune system's ability to attack cancer cells. It works by blocking a protein that can inhibit immune responses, thus promoting a stronger attack on the cancer by the body's natural defenses.

What is already known about the treatment

Durvalumab – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating resectable, early-stage non-small cell lung cancer. It is an immunotherapy drug that works by blocking a protein called PD-L1, which helps the immune system recognize and attack cancer cells. Durvalumab is classified as a monoclonal antibody and is being evaluated for its ability to improve outcomes when used before and after surgery.

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 called "non-small cell" to distinguish it from small cell lung cancer, which behaves differently. In early stages, the cancer is typically confined to the lungs and may not cause noticeable symptoms. As it progresses, it can spread to nearby tissues and lymph nodes. The disease is often detected through imaging tests when symptoms like persistent cough, chest pain, or shortness of breath appear. Early-stage non-small cell lung cancer is considered resectable, meaning it can potentially be removed through surgery.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508852-21-00Protocol codeD9077C00001Estimated enrolment677 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).