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Study on the Effectiveness and Safety of Cisplatin, Carboplatin, Etoposide, and Durvalumab in Patients with Limited Stage Small Cell Lung Cancer

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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 a type of lung cancer known as Limited Disease Small Cell Lung Cancer. The study is investigating the effectiveness and safety of combining certain chemotherapy drugs with an immunotherapy treatment. The chemotherapy drugs being used are Cisplatin, Carboplatin, and Etoposide. These drugs are commonly used to treat various types of cancer by killing cancer cells or stopping them from growing. The immunotherapy drug being tested is called Durvalumab, also known by its code name MEDI4736. Immunotherapy helps the body's immune system recognize and attack cancer cells.

The purpose of this study is to determine if adding Durvalumab to the standard chemotherapy and radiotherapy treatment can improve outcomes for patients with this type of lung cancer. Participants in the study will receive either the standard treatment of chemotherapy and radiotherapy or the same treatment with the addition of Durvalumab. The study will last for a period of 18 months, during which the progress of the disease will be monitored to see if the cancer stops growing or shrinks.

Throughout the study, the safety and tolerability of the treatments will be closely observed. The main goal is to see if the combination of treatments can help patients live longer without the cancer getting worse. Additionally, the study will assess the overall survival rate, the response of the cancer to the treatment, and the quality of life of the participants. This research aims to provide valuable information that could lead to improved treatment options for patients with Limited Disease Small Cell Lung Cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, informed consent is required. This involves understanding the nature and potential consequences of the trial.
Eligibility is confirmed based on specific criteria, including age, diagnosis of limited disease small cell lung cancer, and overall health status.
Step 2
Initial treatment phase
The initial treatment involves a combination of chemotherapy and radiotherapy.
Chemotherapy includes the use of cisplatin or carboplatin and etoposide, administered through intravenous infusion.
The specific dosage and frequency of these medications are determined by the healthcare provider based on individual health conditions.
Step 3
Combination with immunotherapy
During the treatment, durvalumab, an immunotherapy drug, is introduced. It is also administered intravenously.
The goal is to enhance the effectiveness of the chemotherapy and radiotherapy.
Step 4
Maintenance therapy
Following the initial treatment phase, maintenance therapy with durvalumab continues.
This phase aims to maintain the benefits achieved during the initial treatment.
Step 5
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to assess the progression of the disease and the patient's response to treatment.
Progression-free survival is evaluated after 18 months, along with other health assessments.

Who can join the trial?

15 criteria

The patient must provide a signed and dated form showing they agree to participate in the study.
The patient must be able to understand the purpose and effects of the clinical trial.
The patient must be a male or female who is at least 18 years old.
The patient must have a confirmed diagnosis of **Limited Disease Small Cell Lung Cancer**. This means the cancer is in a limited area and has not spread widely.
The patient must have tumor tissue available for research testing.
The patient must have an **ECOG PS** score of 0-1, which means they are fully active or have some symptoms but can still do light work.
The patient must have at least one measurable tumor according to specific medical guidelines called **RECIST 1.1**.
The patient must weigh more than 30 kg (about 66 pounds).
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The patient must have normal organ function, which includes:
- Hemoglobin level of at least 9.0 g/dL (a measure of red blood cells).
- **Absolute neutrophil count (ANC)** of at least 1.5 x 10⁹/L (a type of white blood cell).
- **Platelet count** of at least 100 x 10⁹/L (cells that help with blood clotting).
- **AST (SGOT)/ALT (SGPT)** levels no more than 2.5 times the normal limit (liver enzymes).
- **Serum Bilirubin** level no more than 1.5 times the normal limit (a substance made by the liver).
- **Estimated glomerular filtration rate (eGFR)** of at least 30 mL/min for Carboplatin or 60 mL/min for Cisplatin, which measures kidney function.
- The patient must have a life expectancy of at least 12 weeks, as judged by the doctor.

Who cannot join the trial?

7 criteria

Patients with other types of cancer besides Limited Disease Small Cell Lung Cancer cannot participate. This means the study is only for those with this specific type of lung cancer.
Patients who have had another cancer in the past, unless it was a type that is not expected to come back, are excluded. This is to ensure the study focuses on the specific cancer being researched.
Patients who have received certain treatments for their cancer before, such as chemotherapy or radiation, may not be eligible. This is because previous treatments could affect the study results.
Patients with serious health conditions that could interfere with the study or make participation unsafe are not allowed. This includes conditions like severe heart disease or uncontrolled infections.
Patients who are pregnant or breastfeeding cannot take part in the study. This is to protect the health of the mother and baby.
Patients who are unable to follow the study procedures or attend the required visits are excluded. This ensures that all participants can fully engage in the study.
Patients who are participating in another clinical trial at the same time are not eligible. This is to avoid any interference between different studies.

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Verified sites

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Asklepios Kliniken Hamburg GmbH
Hamburg, Germany
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Justus-Liebig-Universitaet Giessen
Giessen, Germany
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Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung
Essen, Germany

Trial locations

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Investigated drugs

Cisplatin is a chemotherapy medication used to treat various types of cancer, including small cell lung cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. Carboplatin is another chemotherapy drug similar to Cisplatin. It is used to treat cancer by interfering with the DNA of cancer cells, stopping their growth and multiplication. Etoposide is a chemotherapy medication that helps treat cancer by inhibiting an enzyme that cancer cells need to divide and grow. It is often used in combination with other chemotherapy drugs. Durvalumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used to enhance the body's natural defenses to fight cancer, particularly in small cell lung cancer. Radiotherapy is a treatment that uses high-energy rays to target and kill cancer cells. It is often used in combination with chemotherapy to increase the effectiveness of cancer treatment.

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating limited disease small cell lung cancer. The main therapeutic indication for Durvalumab is to enhance the body's immune response against cancer cells. At the molecular level, it works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. Durvalumab 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

Limited Disease Small Cell Lung Cancer – This is a type of lung cancer characterized by the presence of small, round cancer cells that grow rapidly. It is termed "limited" when the cancer is confined to one side of the chest and can be treated with a single radiation field. The disease progresses quickly, often spreading to nearby lymph nodes and other parts of the body if not managed. Small cell lung cancer is known for its aggressive nature and tendency to recur after initial treatment. It is often associated with smoking and can cause symptoms such as coughing, chest pain, and difficulty breathing. Early detection is crucial for managing the disease effectively.