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Study on the Effects of Defosbarasertib and Durvalumab for Patients with Extensive-Stage 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 Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The study is exploring the potential benefits of adding a new treatment called Defosbarasertib (also known by its code name AZD2811) to the current standard maintenance therapy, which includes a medication called Durvalumab. Both medications are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective and safe the combination of AZD2811 and Durvalumab is when used as a maintenance therapy after initial treatment with platinum-based chemotherapy and Durvalumab. Participants in the study will receive these treatments and will be monitored over time to see how well they respond. The study will look at how many participants are alive and have not experienced cancer progression at different time points, such as 12 months after starting the maintenance therapy.

Throughout the study, participants will be regularly assessed to track their health and any changes in their condition. The study aims to gather information on the overall survival of participants, their progression-free survival, and any side effects they may experience. This information will help researchers understand the potential benefits and risks of using AZD2811 in combination with Durvalumab for treating ES-SCLC.

1 initiation of treatment

Upon joining the study, treatment begins with a combination of medications designed for patients with extensive-stage small-cell lung cancer (ES-SCLC).

The treatment involves the use of two medications: defosbarasertib and durvalumab.

2 administration of medications

Defosbarasertib is administered as a suspension for intravenous infusion. This means it is given directly into the bloodstream through a vein.

Durvalumab is provided as a solution for infusion, also administered intravenously.

3 maintenance therapy

The study focuses on the combination of AZD2811 (another name for defosbarasertib) and durvalumab as maintenance therapy.

This phase follows initial treatment with platinum-based chemotherapy combined with durvalumab.

4 evaluation of treatment efficacy

The main goal is to assess the effectiveness of the treatment by measuring the proportion of participants who are alive and whose disease has not progressed after 12 months.

This is referred to as being ‘alive and progression-free at 12 months’ (APF12).

5 monitoring and assessments

Participants will undergo regular assessments to monitor their health and the progression of the disease.

These assessments will include evaluations of overall survival, progression-free survival, and response to treatment.

6 safety and tolerability

The safety and tolerability of the treatment will be closely monitored throughout the study.

This involves tracking any side effects or adverse reactions to the medications.

7 study duration

The estimated end date for the study is August 30, 2024.

Participants will be involved in the study until this date or until the study objectives are met.

Who Can Join the Study?

  • Must have documented evidence of extensive stage small-cell lung cancer (ES-SCLC), which means the cancer has spread widely in the body.
  • Should be suitable to receive a platinum-based chemotherapy regimen, which is a type of cancer treatment using specific drugs, combined with durvalumab, a medication that helps the immune system fight cancer, as the first treatment for ES-SCLC.
  • Must not have had any previous immune-mediated therapy, which is a treatment that uses the body’s immune system to fight cancer.
  • Must have a life expectancy of at least 12 weeks, meaning the doctor expects the patient to live for at least 12 more weeks.
  • Must have an ECOG performance status of 0 or 1 at enrollment, which is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but nearly fully active.
  • Both male and female participants are eligible.

Who Cannot Join the Study?

  • Patients who have already received treatment for their extensive disease small-cell lung cancer cannot participate.
  • Individuals with other serious health conditions that might interfere with the study treatment are not eligible.
  • Pregnant or breastfeeding women are excluded from the trial.
  • Participants who are unable to follow the study procedures or attend scheduled visits are not allowed to join.
  • Anyone with a history of allergic reactions to the study drugs or similar medications cannot take part.
  • Patients with active infections that require treatment are not eligible.
  • Individuals with a history of another type of cancer, unless it has been successfully treated and is not expected to return, are excluded.
  • People with certain heart conditions that could be worsened by the study drugs are not allowed to participate.
  • Participants who have received another investigational drug within a certain period before the study starts are not eligible.
  • Anyone with a known history of drug or alcohol abuse that could interfere with the study is excluded.

Where you can join this trial?

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Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
12.01.2021

Trial locations

Investigated drugs:

AZD2811 is an investigational medication being studied for its potential to help treat extensive stage small-cell lung cancer. It is being tested in combination with another medication to see if it can help prevent the cancer from getting worse after initial treatment.

Durvalumab is a type of immunotherapy that helps the body’s immune system fight cancer. It is used in this study as part of a combination therapy to see if it can improve outcomes for patients with extensive stage small-cell lung cancer when used after initial chemotherapy.

Investigated diseases:

Small-cell lung cancer (SCLC) – This is a fast-growing type of lung cancer that primarily affects smokers. It is characterized by small cells that multiply quickly and form large tumors. SCLC often starts in the bronchi, which are the main airways of the lungs, and can spread rapidly to other parts of the body, including the lymph nodes, liver, bones, and brain. The disease is typically divided into two stages: limited stage, where cancer is confined to one lung and nearby lymph nodes, and extensive stage, where it has spread more widely. Symptoms may include coughing, chest pain, shortness of breath, and weight loss. Due to its aggressive nature, SCLC is often diagnosed at an advanced stage.

Trial ID:
2024-511887-10-00
Protocol code:
D6132C00001
NCT ID:
NCT04745689
Trial Phase:
Therapeutic exploratory (Phase II)

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