Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

ETOP 21-21 BOUNCE: A multicentre, randomised, phase II trial of brigatinib consolidation versus observation or durvalumab in patients with unresectable stage III NSCLC and ALK-rearrangement, after definitive chemo-radiotherapy.

This study is for individuals diagnosed with a specific type of lung cancer known as non-small cell lung cancer (NSCLC) which has a particular gene change called an ALK-rearrangement. These patients have already had chemotherapy and radiation therapy for their cancer, which doctors couldn't completely remove with surgery. The trial wants to see if giving a drug called Brigatinib after these initial treatments works better at stopping the cancer from growing or coming back compared to simply watching to see what happens, or using another drug called Durvalumab (also known as Imfinzi). We want to find out which approach keeps the cancer at bay for the longest time, and we'll also be looking at how long people live, if the cancer spreads to the brain, and any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

ETOP IBCSG Partners Foundation

Enrolment target

Start

10 Nov 2023

Non-small cell lung cancer (NSCLC)

What is this study about?

This study is designed for individuals who have a specific type of lung cancer called non-small cell lung cancer (NSCLC) that has spread locally but cannot be fully removed by surgery. Crucially, their cancer also has a particular genetic feature called an ALK-rearrangement. These patients have already completed a standard course of treatment, which included chemotherapy and radiation therapy.

The main goal of this trial is to figure out the best next step after someone has finished their initial chemotherapy and radiation. We're comparing three different approaches: giving a drug called Brigatinib, giving a drug called Durvalumab (also known as Imfinzi), or simply observing the patient without additional medication to see how the cancer behaves. Brigatinib and Durvalumab are both types of targeted therapies or immunotherapies that can help fight cancer.

We want to see which of these approaches is most effective at stopping the cancer from growing or spreading for the longest period. This is important because finding ways to keep the cancer under control for longer can significantly improve a person's health and quality of life. By understanding which treatment works best, doctors can make more informed decisions for patients with this specific type of lung cancer in the future.

Key takeaways

This study is for a specific type of lung cancer with an ALK-rearrangement.
It's exploring new treatments after chemotherapy and radiation therapy.
Compares Brigatinib, Durvalumab, or observation to see which keeps cancer from growing longer.
Aims to improve outcomes for people with this type of lung cancer.
Participation involves regular checks and potentially new medications.

Who may be eligible?

To be considered for this study, you would need to be an adult, at least 18 years old. Both men and women can take part.

Key to eligibility is having non-small cell lung cancer (NSCLC) that doctors couldn't remove with surgery, and importantly, your cancer must have a specific gene change called an ALK-rearrangement. You would also need to have recently completed a course of treatment that included both chemotherapy and radiation therapy for your cancer.

There will be other detailed health checks to make sure the study is right and safe for you, as is standard practice for any medical research. These checks will be explained by the study team.

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 non-small cell lung cancer (NSCLC)?
Does your cancer have an ALK-rearrangement?
Has your cancer been classified as 'unresectable Stage III'?
Have you recently completed chemotherapy and radiation for your cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned by chance to one of three groups: one group would receive Brigatinib, another would receive Durvalumab (Imfinzi), and the third group would have observation only. This random assignment ensures a fair comparison between the treatments.

You would have regular visits to the hospital or clinic for assessments, which would include physical exams, blood tests, and scans (like CT scans) to check on your cancer and overall health. If you are in a treatment group, you'd receive the study medication as directed by the doctors. The exact frequency of visits and how long you take the medication would depend on which group you are in and how you respond. The study will continually monitor your progress and any side effects. After your treatment period, there will be follow-up appointments to track your health over time.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a treatment that could be more effective at controlling your cancer for longer than current standard approaches, or at least help researchers understand more about your condition. However, there are also potential risks involved, mainly from side effects of the medications. These side effects can vary and will be fully explained by the study team. As with all clinical trials, neither the benefits nor the risks are guaranteed, and there's always a chance the treatment might not work for you, or you might experience unwanted effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Spain
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Unverified
Italy
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Unverified
France
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Unverified
Poland

Common questions

What is Non-Small Cell Lung Cancer (NSCLC)?

It's the most common type of lung cancer. This study focuses on a specific kind that has an 'ALK-rearrangement', which is a particular change in the cancer cells.

What is an ALK-rearrangement?

This is a specific genetic change found in some cancer cells. It means the ALK gene works differently, which can make the cancer grow. Knowing about it helps doctors choose targeted treatments.

What are Brigatinib and Durvalumab (Imfinzi)?

Brigatinib is a 'targeted therapy' drug designed to attack cancer cells with the ALK-rearrangement. Durvalumab (Imfinzi) is an 'immunotherapy' drug that helps your body's immune system fight the cancer.

What does 'unresectable Stage III' mean?

This means the cancer has grown into nearby tissues or lymph nodes but hasn't spread to distant parts of the body, and doctors couldn't completely remove it with surgery.

What does 'consolidation' mean in this study?

It refers to the treatment given after initial chemotherapy and radiation therapy, aimed at strengthening the effect of those first treatments and keeping the cancer from coming back or growing.