Not yet recruitingPHASE1INTERVENTIONAL

Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer

This study is for people with a type of advanced lung cancer called non-small cell lung cancer that has spread to different parts of the body. If your cancer has grown even though you've been on immunotherapy, this study explores if combining a special type of radiation, called pulse radiotherapy, with your existing immunotherapy can help. The main goal is to check how safe this new treatment approach is and to see if it causes any serious side effects. Researchers will also be looking at whether it helps stop the cancer from growing and how it affects patients' quality of life. About 32 patients will take part.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

Houda Bahig

Enrolment target

Start

01 Apr 2025

Estimated completion

01 Aug 2027

Non Small Cell Lung Cancer Metastatic Lung Cancer

What is this study about?

This research study is looking for a better way to treat lung cancer, specifically a type called non-small cell lung cancer, which is the most common kind. If this cancer has spread to other parts of your body (doctors call this 'metastatic') and has continued to grow even with immunotherapy treatments, then this study might be for you. Immunotherapy helps your own body's immune system fight cancer, but sometimes it stops working or doesn't work well enough.

The study is trying to understand if giving a special kind of radiation treatment, called 'pulse radiotherapy', alongside your current immunotherapy can make a difference. The idea is that this radiation might help shrink the tumours directly and also make the immunotherapy work better. This is a 'Phase 1' study, meaning the main aim is to check the safety of this new combined treatment and see what kind of side effects it might cause.

Researchers will also be carefully watching to see if this treatment helps slow down the cancer's growth, how long people live, and how it affects their overall well-being. They believe this combination could improve how patients respond to treatment while keeping side effects manageable. This study will involve 32 patients to gather important information about this promising approach.

Key takeaways

This study is testing a new combined treatment for advanced lung cancer that has progressed on immunotherapy.
It uses a special radiation treatment called pulse radiotherapy alongside existing immunotherapy.
The main goal is to check the safety of this new combination.
It's a Phase 1 study, meaning it's an early stage of testing.
About 32 patients will take part.
Hope is that it might improve treatment outcomes and quality of life.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have non-small cell lung cancer that has spread to five or more places in your body, and your cancer must have gotten worse while you've been receiving immunotherapy (with or without chemotherapy).

It's important that your general health is good enough to receive treatment, as judged by the study doctors. Even if you have brain tumours, you might still be able to join, although these tumours won't be counted towards the five or more spread locations. The doctors will also need to make sure that the radiation can be given safely to the areas of your cancer.

However, you can't join if you are pregnant or breastfeeding, have certain medical conditions that would make radiation treatment unsafe (like specific lung conditions or active autoimmune diseases), or if you wouldn't be able to receive immunotherapy for other reasons.

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 or older?
Do you have non-small cell lung cancer that has spread?
Has your cancer grown while you've been on immunotherapy?
Has your cancer spread to 5 or more places in your body?
Are you generally healthy enough for treatment?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive your immunotherapy treatment. In addition, you will receive up to three cycles of a special type of radiation called pulse radiotherapy. During each cycle, the radiation will target between two and five of your cancer sites that have grown. The study doctors will carefully decide which sites are best to treat with radiation.

You will have regular appointments for check-ups and tests. These will include scans to see how the cancer is responding and to monitor for any side effects. You will also be asked about your general health and how you are feeling to understand the treatment's effect on your quality of life. The exact number of visits and the total length of your participation will depend on how you respond to the treatment and for how long you continue to benefit. Your participation will involve close monitoring for at least 180 days after your radiation treatment.

Potential risks and benefits

Taking part in this study might offer a potential benefit if your cancer has not responded well to current immunotherapy. The aim is that combining radiation with immunotherapy could help shrink tumours and make your immunotherapy work better, potentially slowing down the cancer's growth. However, as with any new treatment, there are potential risks, mainly related to side effects from the radiation and combination with immunotherapy. Doctors will closely monitor you for any side effects, especially within the first six months of radiation treatment. You will be fully informed about these risks before you decide to join, and you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Centre Hospitalier de l'Université de Montréal
Verified postcode
Montreal, Canada

Common questions

What is 'pulse radiotherapy'?

It's a special way of giving radiation treatment, often in cycles, that has shown promise in helping immunotherapy work better against cancer.

Why combined with immunotherapy?

Researchers think that radiation might make cancer cells more visible to your immune system, helping your immunotherapy fight the cancer more effectively.

What does a 'Phase 1' study mean?

It's the first stage of testing a new treatment in people. The main goal is to find out if it's safe and what the right dose is, rather than how effective it is yet.

Will I still get my regular cancer treatment?

Yes, you will continue with your immunotherapy, and any other regular treatments like chemotherapy might be temporarily adjusted during the radiation periods.

What kind of side effects might I expect?

The study will closely monitor all side effects. Radiation can cause different effects depending on the part of the body treated, and combining it with immunotherapy might also have unique side effects.

How to find out more

Houda Bahig, MD PhD

houda.bahig.med@ssss.gouv.qc.ca 514-890-8254 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.