RecruitingPHASE2INTERVENTIONAL

Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC

This study is for people with stage 3 non-small cell lung cancer. These patients have already had a combination of chemotherapy and immunotherapy, followed by surgery, but still have some cancer cells remaining, usually in their lymph nodes. Doctors are trying to find out if having radiation therapy after surgery, targeted at these remaining cancer areas, can lead to better outcomes. Researchers will compare patients who receive this extra radiation to those who don't, looking at how long they stay free from cancer and their overall health. The study also investigates side effects and quality of life for all participants, aiming to understand if this post-surgery radiation is a beneficial treatment step for this group of patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

118

Start

29 Jan 2026

Estimated completion

01 Feb 2032

Non Small Cell Lung Cancer Stage III Lung Cancer

What is this study about?

This study is designed for individuals diagnosed with a specific type of lung cancer called non-small cell lung cancer, which is at stage 3. At this stage, the cancer has grown more and might have spread to nearby lymph nodes, but not to other distant parts of the body. Before surgery, these patients usually have a combination of treatments like chemotherapy and immunotherapy. After surgery, some cancer cells might still be found, often in the lymph nodes.

The main question this research wants to answer is whether having a type of treatment called radiotherapy *after* surgery makes a difference for these patients. Radiotherapy uses high-energy rays to kill cancer cells. The doctors are looking to see if this additional radiotherapy helps people live longer without their cancer coming back, compared to those who don't receive it. They will also look at how patients feel, the side effects they experience, and their general quality of life.

By carefully comparing these two groups of patients over several years, the study hopes to find out if this extra step of radiotherapy is a helpful and safe treatment option for people in this situation. The results could help doctors decide on the best treatment plans for future patients with stage 3 non-small cell lung cancer who have some cancer remaining after their initial treatments and surgery.

Key takeaways

This study is for stage 3 non-small cell lung cancer patients who have had initial chemotherapy, immunotherapy, and surgery.
It investigates if radiation therapy after surgery improves outcomes for those with remaining cancer cells.
Participants will be randomly assigned to receive post-operative radiation or not.
The study will track cancer recurrence, survival, quality of life, and side effects.
Participation involves regular follow-up appointments for up to 5 years.

Who may be eligible?

To join this study, you need to be at least 18 years old and able to understand and sign consent forms. You must have stage 3 non-small cell lung cancer that has been confirmed by a biopsy. Before your surgery, you would have had full body scans, including a brain scan, to make sure the cancer hadn't spread far.

You would have already received a course of chemotherapy and immunotherapy before your surgery, which must have successfully removed all visible cancer (meaning it was a 'complete' surgery). However, after examining the removed tissue, it must show that some cancer cells were still present, particularly in the lymph nodes. Your lungs should also be working well enough after surgery, and you should not have received radiation to your chest before, or have certain other medical conditions like active lung inflammation or other recent cancers.

You cannot join if you are pregnant, had chest radiation before, had your lung surgery more than 24 weeks ago, or if your cancer has returned or spread to other areas. There are also exclusions for certain lung conditions or other health issues that might make radiation unsafe.

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 stage 3 non-small cell lung cancer?
Have you already had chemotherapy and immunotherapy *before* your surgery?
Did your surgery successfully remove the main tumour, but tests showed some cancer cells remained in your lymph nodes?
Have you *not* had radiation therapy to your chest before?
Is it less than 24 weeks since your lung surgery?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups: one group will receive post-operative radiation therapy, and the other will not. The radiation therapy would involve regular visits to the hospital for treatment sessions over a period of time. Everyone in the study will have regular check-ups, scans, and possibly blood tests to monitor their health, see if the cancer comes back, and check for any side effects.

These follow-up appointments and assessments will continue for up to 5 years after your treatment. The study doctors and nurses will explain all the details of what is involved, including the number of visits, the tests you'll have, and how long each part of the study might take. The total time researchers will be studying results and collecting data is expected to be about 7 years.

Potential risks and benefits

Taking part in this study may offer benefits, such as potentially improving how long you live without your cancer returning, if radiation therapy proves effective for your specific situation. You'll receive very close monitoring from a medical team experienced in lung cancer care. However, there are also risks; radiation therapy can cause side effects like tiredness, skin irritation, or inflammation in the lungs or oesophagus. The exact benefits and risks for you will depend on your individual health. Remember, deciding whether to participate is entirely your choice, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

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

Common questions

What is 'neoadjuvant chemo-immunotherapy'?

This means you had a combination of chemotherapy and immunotherapy drugs *before* your surgery. These treatments are given to shrink the tumour and kill cancer cells.

What does 'Stage III NSCLC with residual disease' mean?

This means your lung cancer is at a more advanced stage (Stage 3). 'Residual disease' means that even after surgery, some cancer cells were still found when the removed tissue was checked under a microscope, usually in the lymph nodes.

What is 'post-operative radiotherapy' (PORT)?

PORT is a type of radiation treatment given *after* surgery. It uses high-energy rays to target and destroy any remaining cancer cells in the area where the tumour was removed or in nearby lymph nodes.

Will I know if I'm getting radiotherapy or not?

This is a 'randomised trial'. You will be put into a group by chance, either receiving radiotherapy or not. Your study healthcare team will explain whether you will know which group you are in.

How long will the study last for me?

You will be followed up by the study team for up to 5 years after your treatment starts to monitor your health and any cancer progression.

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.