AuthorisedTherapeutic exploratory (Phase II)Interventional

Durvalumab (MEDI4736) in combination with consolidative radiochemotherapy and ablative stereotactic radiotherapy in extensive stage SCLC

This research study is investigating a new treatment approach for advanced small cell lung cancer, which is a type of lung cancer that has spread. It combines standard treatments – chemotherapy (Carboplatin, Etoposide, and Cisplatin) and radiotherapy (focused radiation) – with a new drug called Durvalumab, also known as Imfinzi. Durvalumab is an immunotherapy, which helps your body's immune system fight cancer. The main goal is to see if this combination can stop the cancer from growing for at least a year. Researchers want to find out if this new approach can be more effective than current treatments for people with this specific type of lung cancer. This is a Phase II study, meaning it's still in the earlier stages of testing.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitaet Des Saarlandes

Enrolment target

Start

29 Oct 2024

extensive stage small cell lung cancer (SCLC)

What is this study about?

This study is called the 'Durvalumab (MEDI4736) in combination with consolidative radiochemotherapy and ablative stereotactic radiotherapy in extensive stage SCLC' trial. That's a mouthful, but let's break it down. It's focused on people who have a type of advanced lung cancer called extensive-stage small cell lung cancer. 'Extensive-stage' means the cancer has spread beyond the main area in the lung.

The study is looking at whether combining an existing therapy, Durvalumab (known as Imfinzi), with standard chemotherapy and a special type of radiation treatment can help patients live longer without their cancer getting worse. Durvalumab is an 'immunotherapy' drug, which works by helping your body's own immune system recognise and fight cancer cells more effectively. The chemotherapy drugs used are Carboplatin, Etoposide, and Cisplatin, which are common treatments for this kind of cancer.

The main aim of the study is to see how many patients treated with this combination are still alive and have not had their cancer grow or spread within one year of starting treatment. This is a Phase II study, which means it's testing whether the new treatment approach is safe and effective enough to be studied in a larger group of people later on. The researchers hope that this new combination could offer a better way to manage advanced small cell lung cancer.

Key takeaways

Targets advanced small cell lung cancer.
Combines immunotherapy (Durvalumab) with chemotherapy and radiotherapy.
Aims to see if the new combination can control cancer for longer.
This is a Phase II study, exploring safety and effectiveness.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

To join this study, you need to be at least 18 years old – there's no upper age limit. The study is open to both men and women.

More detailed checks would be done by the study doctors to make sure this trial is right for you. They would look at your specific cancer diagnosis to confirm it's extensive small cell lung cancer and check your general health to ensure you're well enough to take part in the treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have extensive stage small cell lung cancer?
Are you able to undertake intense treatments like chemotherapy and radiotherapy (as assessed by a doctor)?
Are you open to trying a newer combination of treatments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive a combination of treatments. This includes Durvalumab (Imfinzi) given through a drip (infusion), along with chemotherapy drugs (Carboplatin, Etoposide, and Cisplatin), also given by infusion. You would also have focused radiotherapy treatments, which are carefully planned to target the cancer.

You would need to attend regular visits at the hospital for your treatments, health checks, and to monitor how you are responding. This would involve repeat scans and blood tests. Doctors would keep a close eye on your health and any side effects you might experience. The total duration of your participation, including follow-up, would be fully explained before you join.

Potential risks and benefits

Like all medical treatments, there are potential benefits and potential risks to consider. The potential benefit is that this new combination of treatments might be more effective at controlling your cancer than standard therapies alone, and it could help you live longer without your cancer progressing. However, there's no guarantee this will happen, and you could experience side effects from any of the medications or radiotherapy. These side effects would be fully explained by the study team. Remember, taking part in a study is always your choice, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is 'extensive stage small cell lung cancer'?

This is a type of lung cancer that has been identified as having spread beyond the original primary tumour in the lung.

What is Durvalumab (Imfinzi)?

It's a type of immunotherapy drug that helps your body's immune system fight cancer cells.

What does a 'Phase II study' mean?

It means this is an earlier stage of research, testing if the new treatment is safe and effective enough to be studied in a larger group of people.

Will I still get my normal cancer treatment?

This study combines standard chemotherapy and radiotherapy with a new drug. The treatment plan will be designed by the study doctors.

What is the main goal of this study?

The main goal is to see if the new combination treatment can stop the cancer from growing for at least one year.