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Study on Durvalumab and Chemotherapy for Patients with Resectable Stage III 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 in stages IIIA and selected resectable stages IIIB. The treatment being investigated involves a medication called durvalumab, which is also known by its code name MEDI4736. Durvalumab is a type of drug that helps the immune system fight cancer by targeting a protein called PD-L1. The study aims to understand the effectiveness of combining this medication with other treatments like chemotherapy and radiation therapy, followed by surgery or additional radiation therapy.

The purpose of the study is to evaluate how well this combination of treatments works in preventing the cancer from getting worse over a period of two years. Participants in the study will receive either the full combination of treatments, including durvalumab, or a similar treatment plan without durvalumab. The study will last for about 32 weeks, during which participants will undergo various treatments and follow-up visits to monitor their health and the progress of the cancer.

Throughout the study, researchers will be looking at several outcomes, including how long participants live without the cancer progressing, overall survival rates, and any side effects related to the treatments. The study will also assess the quality of life of participants during and after the treatment. This information will help determine the potential benefits and risks of using durvalumab in combination with other therapies for treating stage III non-small cell lung cancer.

1 induction chemotherapy

The initial phase involves receiving chemotherapy to reduce the size of the tumor. This is done to prepare for the next stages of treatment.

Chemotherapy drugs are administered through an intravenous (IV) line. The specific drugs and their dosages will be determined by the medical team based on individual needs.

2 chemoradiotherapy

Following induction chemotherapy, a combination of chemotherapy and radiation therapy is provided. This aims to further shrink the tumor and target cancer cells more effectively.

Radiation therapy uses high-energy rays to destroy cancer cells, while chemotherapy continues to be administered to enhance the effects of radiation.

3 surgery or definitive chemoradiation boost

Depending on the response to previous treatments, surgery may be performed to remove the tumor. If surgery is not possible, a boost of chemoradiation is given to maximize treatment effectiveness.

The decision between surgery and additional chemoradiation is based on the tumor’s resectability and the patient’s overall health.

4 consolidation therapy with durvalumab

After surgery or the chemoradiation boost, consolidation therapy with durvalumab is administered. Durvalumab is a medication that helps the immune system attack cancer cells.

Durvalumab is given as an infusion, typically every two weeks, for a duration of up to 32 weeks. This phase aims to prevent cancer recurrence and improve long-term outcomes.

5 follow-up and monitoring

Regular follow-up visits are scheduled to monitor health and detect any signs of cancer recurrence. These visits include physical exams, imaging tests, and laboratory tests.

The frequency and duration of follow-up appointments are determined by the healthcare team, based on individual progress and needs.

Who Can Join the Study?

  • Body weight must be more than 30 kg.
  • Must have a life expectancy of more than 12 weeks.
  • Normal organ and bone marrow function, which includes:
    • Hemoglobin level of at least 9.0 g/dL.
    • Absolute neutrophil count (a type of white blood cell) greater than 1500 per mm3.
    • Platelet count of at least 100,000 per mm3.
    • Serum bilirubin (a substance made by the liver) no more than 1.5 times the normal limit, except for patients with Gilbert’s syndrome.
    • AST/ALT (liver enzymes) no more than 2.5 times the normal limit.
    • Creatinine clearance (a measure of kidney function) greater than 40 mL/min.
  • For women, evidence of being post-menopausal or a negative pregnancy test if premenopausal.
  • Willing and able to follow the study protocol, including treatments and visits.
  • Stable heart function, with no heart attack in the last 6 months and no severe heart failure.
  • Age between 18 and 75 years.
  • Both male and female patients can participate, but must use effective birth control methods.
  • Confirmed diagnosis of non-small cell lung cancer.
  • Specific stages of lung cancer (IIIA and selected IIIB) that are potentially removable by surgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means fully active or restricted in physically strenuous activity but able to carry out light work.
  • Cancer that can be surgically removed at the time of joining the study.
  • Meet the criteria for surgery and have a good general health condition for the treatment plan.
  • Able to provide signed informed consent, agreeing to the study’s requirements and restrictions.

Who Cannot Join the Study?

  • Patients with other types of cancer besides non-small cell lung cancer in stages IIIA (N2) and selected resectable stages IIIB cannot participate. Non-small cell lung cancer is a type of lung cancer that grows and spreads more slowly than small cell lung cancer.
  • Patients who are not in the age range specified for the study cannot participate. The study includes specific age groups, so patients must fall within these age ranges.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation, such as children or those unable to give consent.

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
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH Hemer Germany
Uppaujaaktncakyladffk Eesdu Alk Essen Germany
Uneptcuvynjcwanssvlmq Atfyqtxv Augsburg Germany

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

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
02.12.2019

Trial locations

Investigated drugs:

Durvalumab is a medication used in this trial. It is an antibody that helps the immune system to recognize and attack cancer cells. In this study, it is used to see if it can improve the treatment outcomes for patients with stage III non-small-cell lung cancer when added to other therapies.

Induction Chemotherapy is a treatment given to shrink the tumor before the main treatment. In this trial, it is used to reduce the size of the lung cancer and make it easier to remove or treat with other methods.

Chemoradiotherapy combines chemotherapy and radiation therapy to increase the effectiveness of treatment. This approach is used in the trial to target cancer cells more aggressively, aiming to improve the chances of controlling the disease.

Surgery is a procedure to remove the cancerous tumor from the lung. In this trial, surgery is considered for patients whose tumors can be removed, as part of the treatment plan to eliminate cancer.

Radiochemotherapy-Boost is an intensified form of chemoradiotherapy. It involves giving additional doses of radiation and chemotherapy to target any remaining cancer cells after initial treatments, aiming to prevent the cancer from coming back.

Immunotherapy Consolidation is a phase of treatment where immunotherapy is continued after the main treatment to help maintain the response against cancer. In this trial, it involves using durvalumab to support the immune system in keeping the cancer under control.

Investigated diseases:

Non-Small Cell Lung Cancer – 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 cases. The disease typically progresses slowly compared to small cell lung cancer. In stages IIIA (N2) and selected resectable stages IIIB, the cancer has spread to lymph nodes on the same side of the chest or to nearby structures. Treatment often involves a combination of surgery, chemotherapy, and radiation therapy, depending on the stage and specific characteristics of the cancer. The progression of the disease can vary, with some cases remaining stable for long periods, while others may advance more rapidly.

Trial ID:
2024-513039-26-00
Protocol code:
ESPADURVA
NCT ID:
NCT04202809
Trial Phase:
Therapeutic exploratory (Phase II)

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