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Study of Atezolizumab and Dendritic Cell Vaccine for Maintenance Treatment in 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 a treatment that combines two medications: atezolizumab and a special type of vaccine called a dendritic cell vaccine. Atezolizumab, also known by its code name RO5541267, is a medication that helps the immune system fight cancer. The dendritic cell vaccine is designed to boost the body’s natural defenses against cancer cells.

The purpose of the study is to see how well this combination treatment works in keeping the cancer from getting worse over a period of six months. Participants in the study will receive atezolizumab through an intravenous infusion, which means it is given directly into a vein. The dendritic cell vaccine is administered through an injection into the skin. Some participants may receive a placebo instead of the actual treatment to help researchers compare the effects.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of the cancer. The study aims to understand how long the treatment can keep the cancer from progressing and how it affects overall survival. The results will help determine if this combination of atezolizumab and the dendritic cell vaccine is an effective maintenance treatment for patients with ES-SCLC.

1 joining the study

Upon joining the study, a written informed consent is required. This consent confirms understanding and agreement to participate in the trial.

Eligibility is confirmed through a series of tests and assessments, including a diagnosis of extensive stage small cell lung cancer (ES-SCLC) and other health evaluations.

2 initial treatment phase

The initial treatment involves receiving a combination of medications. The first medication is IMMUCOTHEL® 1 mg, administered through an intradermal injection. This means the medication is injected into the skin.

The second medication is Tecentriq 1,200 mg, given as an intravenous infusion. This involves the medication being delivered directly into the bloodstream through a vein.

The frequency and duration of these treatments will be explained by the healthcare team, ensuring understanding of the schedule.

3 maintenance treatment phase

After the initial treatment, the maintenance phase begins. This phase continues the use of Tecentriq in combination with dendritic cell vaccination.

The goal of this phase is to maintain the progress achieved during the initial treatment and to monitor the body’s response.

4 regular monitoring

Throughout the trial, regular monitoring is conducted to assess health status and treatment effectiveness. This includes physical exams, imaging tests, and blood tests.

These assessments help in tracking the progression-free survival rate, which is the main objective of the trial.

5 completion of the trial

The trial is expected to continue until August 2025, but individual participation may vary based on personal health and response to treatment.

Upon completion, a final assessment is conducted to evaluate overall health and the outcomes of the treatment.

Who Can Join the Study?

  • Must have a confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC). This means the cancer has spread widely in the lungs.
  • Must provide written consent to participate in the study.
  • Must be at least 18 years old.
  • Must have a disease that can be measured by specific medical criteria called RECIST 1.1.
  • Must use highly effective birth control if there is a risk of pregnancy, and continue for at least 30 days after the last treatment.
  • Women who can have children must have a negative pregnancy test before starting the study. Women who cannot have children include those who are post-menopausal (no periods for at least a year and over 60 years old), or have had surgery to remove reproductive organs.
  • Must test negative for certain infections, including hepatitis B, hepatitis C, HIV, and others, depending on the region you come from.
  • Must have tumor tissue that is suitable for a specific type of treatment preparation.
  • Must not have received previous cancer treatment for advanced disease.
  • Must have a life expectancy of at least 16 weeks.
  • Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
  • Must have normal organ and bone marrow function, which includes:
    • Enough white blood cells (absolute neutrophil count ≥ 1.5 x 109 cells/L)
    • Enough platelets (≥ 100 x 109/L)
    • Enough hemoglobin (≥ 9 g/dL)
    • Liver enzymes (AST, ALT) within acceptable limits
    • Total bilirubin within acceptable limits, except for certain conditions
    • Creatinine level below 2 mg/dL or a good kidney filtration rate
  • If you had palliative radiotherapy, it must have been completed at least 2 weeks before starting the study treatment. You may receive localized palliative radiotherapy while on the study drug.
  • If you have brain metastases, you can participate if they are not causing symptoms, have been treated, or are stable for at least 2 weeks without steroids or on a stable or decreasing dose of less than 10 mg daily of prednisone or equivalent.
  • Must be willing and able to undergo a procedure called leukapheresis, which involves collecting white blood cells from your blood.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides lung cancer cannot participate.
  • Patients who have had another cancer in the past, unless it was treated and has not come back for at least 5 years, cannot participate.
  • Patients who are currently receiving treatment for another medical condition that might interfere with the study cannot participate.
  • Patients with severe heart problems cannot participate.
  • Patients with uncontrolled high blood pressure cannot participate.
  • Patients with active infections that require treatment cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial within the last 30 days cannot participate.
  • Patients who have a known allergy to the study medication cannot participate.
  • Patients who are unable to follow the study procedures cannot participate.

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
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Hospital Clinic De Barcelona Barcelona Spain
Hnjflikk Urrmhynbmznax Hanvqodg Tarrz y Phdmdz Iuzaptzl Cvdrvw dxrislznvlxyevqrq (khmk Badalona Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
19.05.2021

Trial locations

Investigated drugs:

Atezolizumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, atezolizumab is used to help maintain the progress made after the initial treatment for extensive stage small cell lung cancer. It aims to keep the cancer from growing or spreading further.

Dendritic Cell Vaccination is a therapy that uses your own immune cells to fight cancer. Dendritic cells are a type of immune cell that helps the body recognize and attack cancer cells. In this trial, the dendritic cell vaccination is used in combination with atezolizumab to help maintain the treatment effects and prevent the cancer from coming back or getting worse.

Lung Cancer – Lung cancer is a disease characterized by the uncontrolled growth of abnormal cells in one or both lungs. These abnormal cells do not develop into healthy lung tissue; instead, they divide rapidly and form tumors. As the disease progresses, these tumors can interfere with the lung’s ability to provide oxygen to the bloodstream. Lung cancer can spread to other parts of the body through a process called metastasis. The disease often begins in the cells lining the bronchi and parts of the lung such as the bronchioles or alveoli. Over time, lung cancer can lead to symptoms such as coughing, chest pain, and difficulty breathing.

Trial ID:
2024-518636-36-00
Protocol code:
IOR-IISML42037
NCT ID:
NCT04487756
Trial Phase:
Phase II and Phase III (Integrated)

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