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Study of Durvalumab with Chemoradiation Therapy for Patients with Unresectable, Locally Advanced Non-small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Non-small Cell Lung Cancer (NSCLC), specifically when it is locally advanced and cannot be removed by surgery. The study is investigating the effectiveness of a treatment called durvalumab, which is given alongside standard chemotherapy and radiation therapy. Durvalumab is a medication that helps the immune system fight cancer cells. The trial will compare the results of patients receiving durvalumab with those receiving a placebo, which is a substance with no active medication.

The purpose of the study is to see if adding durvalumab to the usual treatment can help patients live longer without the cancer getting worse. The study will involve several medications, including carboplatin, cisplatin, paclitaxel, etoposide, and pemetrexed disodium, which are commonly used in chemotherapy. Another medication, infliximab, and mycophenolate mofetil, an immunosuppressive agent, are also part of the study. These treatments will be administered over a period of time, and patients will be monitored to assess the effectiveness and safety of the treatment.

Participants in the study will receive their treatment through intravenous infusions, which means the medication is given directly into a vein. The study will last for a maximum of 54 weeks, during which time patients will be closely observed by healthcare professionals. The goal is to determine if the combination of durvalumab and standard treatment can improve the outcomes for patients with this type of lung cancer.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of locally advanced, unresectable non-small cell lung cancer (Stage III) and a performance status of 0 or 1.

A measurable lesion must be present, and life expectancy should be at least 12 weeks.

2 randomization

Participants are randomly assigned to receive either durvalumab with standard chemoradiation therapy or a placebo with standard chemoradiation therapy.

This process ensures that each participant has an equal chance of receiving the investigational treatment.

3 treatment phase

The treatment involves the administration of durvalumab or placebo intravenously, alongside standard chemoradiation therapy.

Chemoradiation therapy includes drugs such as carboplatin, paclitaxel, pemetrexed, etoposide, and cisplatin, administered intravenously according to the standard care protocol.

The duration and frequency of administration are determined by the standard care guidelines for chemoradiation therapy.

4 monitoring and assessments

Regular monitoring is conducted to assess the progression of the disease and the response to treatment.

Assessments include imaging studies and blood tests to measure the concentration of durvalumab and to check for any adverse effects.

The safety and tolerability of the treatment are evaluated throughout the trial.

5 follow-up

After completing the treatment phase, participants enter a follow-up period to monitor long-term outcomes and any delayed side effects.

The follow-up includes regular health assessments and may continue until the estimated end date of the trial in March 2025.

Who Can Join the Study?

  • Patients must have a type of lung cancer called Non-small Cell Lung Cancer (NSCLC) that is locally advanced and cannot be removed by surgery (Stage III).
  • The cancer must be confirmed through a test called histology or cytology, which involves examining cells or tissues under a microscope.
  • Patients should have a performance status of 0 or 1 according to the World Health Organization (WHO) or Eastern Cooperative Oncology Group (ECOG) scale. This means they should be fully active or have some symptoms but can still do light work.
  • There must be at least one cancer area that can be measured and has not been treated with radiation before.
  • Patients should have a life expectancy of at least 12 weeks at the time of joining the study.
  • Both male and female patients are eligible to participate.

Who Cannot Join the Study?

  • Patients who have had another type of cancer in the past, except for certain skin cancers or cervical cancer that has been treated and is not active.
  • Patients who have an active infection that requires treatment with antibiotics, antivirals, or antifungals.
  • Patients who have a history of severe allergic reactions to any of the drugs used in the study.
  • Patients who have an autoimmune disease, which is when the body’s immune system attacks its own healthy cells.
  • Patients who are pregnant or breastfeeding.
  • Patients who have received an organ transplant.
  • Patients who have a condition that affects the brain or nerves, such as seizures or a history of stroke.
  • Patients who have a serious heart condition, such as heart failure or a recent heart attack.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Nr Mai Gqkfo Scjy Elblag Poland
Gassvvqompquevknu Vuwujvxhx Pzxi Avhwnb Ehqqbufd Oesqic Khwndb Gyor Hungary
Nzmnolww Inpqjtok Oasqrjuqc Igl Mgsoc Sacxxebhqjdmvrkbduramppugcky Iqlhcuqe Baxlftvd Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Hungary Hungary
Not recruiting
27.09.2024
Poland Poland
Not recruiting
27.09.2024

Trial locations

Investigated drugs:

Durvalumab is a medication used in this trial to help the immune system attack cancer cells. It is being tested to see if it can improve the outcomes for patients with a specific type of lung cancer that cannot be removed by surgery. The study is looking at how well this medication works when given together with standard treatments for lung cancer.

Platinum-based Chemoradiation Therapy is a standard treatment for certain types of lung cancer. It combines chemotherapy, which uses drugs to kill cancer cells, with radiation therapy, which uses high-energy rays to target and destroy cancer cells. This combination is used to try to stop the cancer from growing and spreading.

Investigated diseases:

Non-small Cell Lung Cancer (Stage III) – This is a type of lung cancer that is locally advanced and cannot be removed surgically. It is characterized by the growth of cancer cells in the tissues of the lung, which may spread to nearby lymph nodes or other parts of the chest. The disease progresses as the cancer cells continue to grow and invade surrounding tissues, potentially affecting the function of the lungs and other organs. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the disease advances, it may lead to more severe respiratory issues and other systemic symptoms.

Trial ID:
2024-515321-29-00
Protocol code:
PACIFIC2/D933KC00001
NCT ID:
NCT03519971
Trial Phase:
Therapeutic confirmatory (Phase III)

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