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Study on Durvalumab and Platinum-Based Drug Combination for Patients with Stage IIB-IIIB 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 type of lung cancer that is common and can be challenging to treat. The study is testing a treatment approach that includes a medication called durvalumab, which is used to help the immune system fight cancer, along with platinum-based chemotherapy. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. The study aims to see how effective this combination is in treating patients with NSCLC that can be surgically removed or is close to being removable.

Participants in the study will first receive durvalumab and chemotherapy before undergoing surgery or a combination of chemotherapy and radiation therapy, known as chemoradiotherapy (CRT). After these treatments, they will continue to receive durvalumab to help prevent the cancer from returning. The study will last for several months, and participants will be closely monitored by healthcare professionals throughout the process. The goal is to determine how well this treatment plan works in increasing the chances of successful surgery and improving overall outcomes for patients with NSCLC.

Other medications involved in the study include pemetrexed, paclitaxel, carboplatin, gemcitabine, cisplatin, docetaxel, vinorelbine, infliximab, and mycophenolate mofetil. These drugs are used in various combinations to treat cancer and support the immune system. The study is designed to assess the effectiveness of these treatments in improving the surgical outcomes and overall health of patients with NSCLC.

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

    Initial treatment phase

    The initial phase involves the administration of neoadjuvant durvalumab combined with platinum-based chemotherapy. This treatment is designed to shrink the tumor before any surgical intervention.

    The medications are administered through intravenous infusion. The specific drugs used in this phase include pemetrexed, paclitaxel, carboplatin, gemcitabine, and cisplatin.

  2. Step 2

    Surgical or chemoradiotherapy decision

    After the initial treatment phase, a decision is made regarding the next step: either proceed with surgery or continue with chemoradiotherapy (CRT).

    This decision is based on the response to the initial treatment and the resectability of the tumor.

  3. Step 3

    Surgery and adjuvant treatment

    If surgery is chosen, it is followed by adjuvant durvalumab treatment to help eliminate any remaining cancer cells.

    The surgery aims to remove the tumor completely, and the adjuvant treatment is administered to prevent recurrence.

  4. Step 4

    Chemoradiotherapy and consolidation treatment

    If chemoradiotherapy is chosen, it is followed by consolidation durvalumab treatment.

    This phase aims to consolidate the effects of CRT and further reduce the risk of cancer returning.

  5. Step 5

    Follow-up and monitoring

    Throughout the trial, regular follow-up appointments are scheduled to monitor health status and response to treatment.

    These appointments include various assessments such as imaging tests and blood work to ensure the treatment is effective and to manage any side effects.

Who can join the trial?

18 criteria

  • Participants must be at least 18 years old at the time of screening.
  • Participants should have adequate heart and lung function, as determined by a team of specialists. This includes specific lung function tests called FEV1 and DLCO.
  • Participants must weigh at least 30 kg.
  • Both males and females can participate. They must follow local rules for birth control during the study.
  • Females of child-bearing potential must have a negative pregnancy test.
  • Female participants must be postmenopausal, surgically sterile, or using a highly effective method of birth control.
  • Male participants must be surgically sterile or use an acceptable method of birth control to prevent pregnancy in a partner.
  • Participants must be able to give informed consent, agreeing to follow the study's requirements.
  • Participants must provide signed and dated written consent before any samples are collected.
  • All races, genders, and ethnic groups are eligible for the study.
  • Participants must have a confirmed diagnosis of **Non-small Cell Lung Cancer (NSCLC)** through specific tests.
  • The cancer must be considered resectable or borderline resectable, confirmed by a team of specialists.
  • The cancer must be at stage IIB to certain stage IIIB, and participants must not have received prior treatment for it.
  • Participants must have a performance status of 0 or 1, meaning they are fully active or have some restrictions but can still do light work.
  • Participants must not have certain genetic mutations known as **EGFR** or **ALK** mutations.
  • Participants must have at least one measurable lesion that has not been previously treated with radiation.
  • Participants must have adequate organ and bone marrow function, as shown by specific blood tests.
  • Participants must have a minimum life expectancy of 12 weeks.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer besides Non-small Cell Lung Cancer (NSCLC) cannot participate.
  • Patients with medical conditions that make surgery impossible or unsafe cannot participate.
  • Patients who have received certain treatments that might interfere with the study cannot participate.
  • Patients with severe or uncontrolled health problems that could affect their safety during the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are unable to follow the study procedures or attend required visits cannot participate.
  • Patients with a history of allergic reactions to the study drugs cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial to help the body's immune system fight cancer. It is given to participants before surgery to shrink the tumor and make it easier to remove. After surgery, it is also used to help prevent the cancer from coming back.

  • Platinum-Based Chemotherapy

    refers to a group of cancer-fighting drugs that contain the metal platinum. These medications are used in combination with durvalumab before surgery to help reduce the size of the tumor in the lungs, making it easier to remove.

  • Chemoradiotherapy (CRT)

    is a treatment that combines chemotherapy and radiation therapy. In this trial, it is used as an alternative to surgery for some participants. The goal is to destroy cancer cells and reduce the tumor size, which can help control the disease.

  • Consolidation Durvalumab

    is the continued use of durvalumab after initial treatments like surgery or chemoradiotherapy. This is done to help maintain the benefits of the initial treatment and to reduce the risk of the cancer returning.

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 in stages IIB to IIIB. The main therapeutic indication for durvalumab is to enhance the body's immune response against cancer cells. At the molecular level, durvalumab works by blocking the PD-L1 protein, which helps cancer cells evade the immune system. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that aims to boost the immune system's ability to fight cancer.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503357-35-00Protocol codeD9106C00002Estimated enrolment140 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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