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Study of Durvalumab for Patients with Early Stage or Locally Advanced Non-Small Cell Lung Cancer Not Suitable for Surgery

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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). The treatment being tested is an immunotherapy drug called Durvalumab, which is also known by its code name MEDI4736. The purpose of the study is to evaluate the safety of using Durvalumab in patients with early-stage or locally advanced NSCLC that cannot be removed by surgery. After receiving Durvalumab, patients will undergo either radiation therapy or a combination of chemotherapy and radiation therapy.

Participants in the study will first receive Durvalumab through an intravenous infusion, which means the medication is given directly into a vein. Following this, they will receive either radiation therapy or chemoradiotherapy, which is a combination of chemotherapy and radiation therapy. The study aims to see how well patients tolerate the treatment and to monitor any side effects that may occur. The trial will also look at how the cancer responds to the treatment, including whether the tumor shrinks or if surgery becomes a viable option.

The study will track the progress of patients over time to gather information on the safety and effectiveness of the treatment. This includes regular check-ups and tests to monitor the health of the participants and the status of their cancer. The trial is expected to continue until the end of 2025, with the goal of providing valuable insights into the use of Durvalumab for treating NSCLC.

1 initial treatment phase

The treatment begins with the administration of durvalumab, a medication used to help the immune system fight cancer cells. It is given as an intravenous (IV) infusion, which means it is delivered directly into the bloodstream through a vein.

The dosage of durvalumab is 50 mg/mL, and it is provided as a concentrate for solution for infusion. The specific dosage and frequency will be determined by the healthcare provider based on individual patient needs.

2 monitoring and assessment

During the treatment, regular monitoring is conducted to assess the safety and effectiveness of durvalumab. This includes checking for any dose-limiting toxicities, which are side effects that prevent further administration of the drug at the current dose.

Patients will undergo scheduled visits and examinations, including physical exams, vital signs checks, electrocardiograms, and laboratory tests to identify any clinically significant abnormalities.

3 radiotherapy or chemoradiotherapy preparation

Following the initial treatment with durvalumab, patients are prepared for radical radiotherapy (RT) or chemoradiotherapy (CRT). This phase is crucial for patients with early-stage or locally advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed.

The goal is to start RT or CRT within 4 to 5 weeks after the administration of durvalumab.

4 completion and follow-up

The clinical trial aims to evaluate the proportion of patients who complete the treatment protocol. This includes the successful administration of durvalumab followed by RT or CRT.

After completing the treatment, patients will continue to be monitored for any adverse events and to assess the overall response to the therapy. This includes measuring the objective response rate, which considers both complete and partial responses to the treatment.

Who Can Join the Study?

  • Patients must be able to give signed informed consent, which means they agree to follow the study rules and understand what the study involves.
  • Patients should be willing and able to follow the study plan, including attending treatment sessions, visits, and exams.
  • Female patients who are not yet in menopause must have a negative pregnancy test or show they are post-menopausal. Post-menopausal means they haven’t had a period for 12 months without another medical reason.
  • Women who can have children must agree to use a highly effective birth control method or not engage in sexual activity during the study and for 3 months after the last treatment. Male partners must use a condom with spermicide during this time.
  • Male patients who are not abstinent and have female partners who can have children must use a condom with spermicide during the study and for 3 months after the last treatment. They should not donate sperm during this period. Female partners must also use effective birth control.
  • Patients must be 18 years or older at the time of screening.
  • Patients should have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • Patients should have a life expectancy of at least 12 weeks.
  • Patients must weigh more than 30 kg (about 66 pounds).
  • Patients must have a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC).
  • Patients should have Stage IIIA NSCLC that is suitable for radiation therapy (RT) or chemoradiation therapy (CRT). This includes patients with Stage IB (> 2 cm) to IIIA NSCLC who are not having surgery due to other health issues or personal choice but can have RT or CRT.
  • Patients must have measurable disease, which means the cancer can be measured using specific criteria called RECIST.
  • Patients must have normal organ and bone marrow function, shown by specific blood test results taken within 14 days before starting the study treatment.

Who Cannot Join the Study?

  • Patients with other types of cancer besides Non-Small Cell Lung Cancer (NSCLC) cannot participate. NSCLC is a type of lung cancer.
  • Patients who have had previous treatments that might interfere with the study cannot participate.
  • Patients with certain medical conditions that could make the study unsafe for them cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have allergies to the study medication cannot participate.
  • Patients who are taking other medications that might interfere with the study cannot participate.
  • Patients with a history of certain heart conditions cannot participate.
  • Patients with severe infections cannot participate.
  • Patients with a history of drug or alcohol abuse cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal

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

Trial status

Country Status Recruitment Start
Portugal Portugal
Recruiting
16.02.2021

Trial locations

Investigated drugs:

Durvalumab (MEDI4736) is an immunotherapy medication used in this clinical trial. It is designed to help the body’s immune system recognize and attack cancer cells. In this study, it is being tested for its safety and effectiveness in patients with early-stage or locally advanced non-small cell lung cancer (NSCLC) that cannot be removed by surgery. The treatment involves using durvalumab before patients receive either radical radiotherapy or a combination of chemotherapy and radiotherapy.

Investigated diseases:

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer (NSCLC) 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 airways and can spread to other parts of the body if not detected early. 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 ID:
2024-518804-32-00
Protocol code:
ESR-18-13828
Trial Phase:
Human Pharmacology (Phase I) – Other

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