Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase II, open label, single arm, multicentre study on THOracic Radiotherapy in Extensive Stage SCLC patients submitted to first line CHT-RT plus Durvalumab (MEDI4736)

This study is for people with extensive small cell lung cancer that has been treated with chemotherapy. Researchers want to find out if adding radiotherapy and a drug called Durvalumab (also known as MEDI4736) can help prevent the cancer from growing or spreading for a longer time. Durvalumab is a type of immunotherapy, which helps your body's immune system fight cancer. This is a Phase II study, meaning it's an early-stage trial looking at how well the new treatment works and if it's safe. While there's no guarantee, the hope is that this combination therapy could offer a better outcome for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Azienda Ospedaliero Universitaria Di Modena

Enrolment target

Start

11 Nov 2024

Extended stage small cell lung cancer patients confirmed histologically in full partial or stable response after platinum-etoposide chemo-immunotherapy candidate to maintenance immunotherapy with Durvalumab.

What is this study about?

This research is focused on a type of lung cancer called extensive small cell lung cancer. This means the cancer has spread beyond the main area of the lung where it started.

Usually, people with this type of cancer receive chemotherapy, which are strong drugs designed to kill cancer cells. In this study, after participants have had their initial chemotherapy treatment with platinum and etoposide, and their cancer is either much better, stable, or completely gone, they will also receive radiotherapy (targeted radiation to kill cancer cells) and a special drug called Durvalumab.

Durvalumab is a type of medicine called immunotherapy. It works by helping your own body's immune system fight the cancer. The main goal of this study is to see how many people are still alive and free from their cancer getting worse a year after starting this combined treatment. The researchers will also look at how long people live overall, how well the treatment controls the cancer locally, if it prevents new growths, its side effects, and how it affects their quality of life. The aim is to find out if this combination could be a more effective treatment option.

Key takeaways

This study explores a new treatment for extensive small cell lung cancer.
It combines radiotherapy with an immune-boosting drug called Durvalumab.
Participants will have already finished their initial chemotherapy.
The main goal is to see if this combination keeps cancer from worsening for longer.
Researchers will also track survival, side effects, and quality of life.
It's a Phase II study, meaning it's an early look at this new treatment approach.

Who may be eligible?

This study is looking for adults aged 18 and over, with no upper age limit. Both men and women can take part.

You would be considered for this study if you have been diagnosed with extensive small cell lung cancer that doctors have confirmed under a microscope. Importantly, you would have already undergone initial chemotherapy treatment involving two drugs called platinum and etoposide. After this initial chemotherapy, your cancer should either be completely gone, significantly shrunk, or stable (not growing).

Essentially, the study is for people who have responded well to their first round of chemotherapy and are now considering further treatment to try and keep the cancer under control.

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?
Have you been diagnosed with extensive small cell lung cancer?
Has your cancer been confirmed by a biopsy?
Have you already completed initial chemotherapy with platinum and etoposide?
Has your cancer responded well (stable, shrunk, or gone) to your initial chemotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the drug Durvalumab. The exact schedule of your treatments, including the radiotherapy, will be carefully planned by the study doctors. You would have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how your cancer is responding to the treatment. These visits are essential to track the effects of the treatment, both good and bad, and to ensure your safety. The study will continue for a period, with follow-up appointments even after treatment finishes, to understand the long-term impact. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any clinical study has potential benefits and potential risks. The potential benefit of this study is that the combination of radiotherapy and Durvalumab might help control your cancer for longer than current treatments, making you feel better or improving your long-term outlook. However, there's no guarantee this will happen. Potential risks include side effects from the Durvalumab, radiotherapy, or their combination, which could range from mild to serious. The study team will closely monitor you for any side effects and will explain these in detail before you decide to join. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual 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
Italy

Common questions

What is 'extensive small cell lung cancer'?

This means your lung cancer has spread beyond the main area where it started to other parts of your body or another part of your lung.

What is Durvalumab?

Durvalumab is a medicine that helps your body's own immune system fight against cancer cells. It's a type of immunotherapy.

What does 'progression-free survival' mean?

This term refers to how long someone lives without their cancer getting worse or spreading, or passing away from any cause if the cancer hasn't worsened.

Will I still get my usual chemotherapy?

Yes, you would have already had your initial chemotherapy treatment (platinum-etoposide) before joining this study. This study 'adds on' to that initial treatment.

Is this a new treatment?

The idea of combining radiotherapy with Durvalumab after initial chemotherapy for this specific type of cancer is what is being investigated. It's an exploratory study to see how well it works.