A study looking at further treatment after initial treatment for advanced non small cell lung cancer (RAMON)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer

Non small cell lung cancer

Secondary cancers

Status:

Closed

Phase:

Phase 1/2

This study is looking at treating cancer cells that might be left behind after initial treatment. Further treatment aims to remove these cells and or treat any symptoms the cancer may cause.

More about this trial

Stage 4 lung cancer means the cancer has spread. This is also called advanced lung cancer. Sometimes it isn’t possible to get rid of all visible disease completely and some disease may remain after treatment. This is called having residual cancer.

You may have further treatment which aims to get rid of these residual sites of disease. Doctors aren’t sure if they all contain cancer cells. The treatment might include one or more of the following:

surgery
radiotherapy
treatment to heat and destroy cancer cells

These are called local consolidative treatments.

You may also have treatment to help with symptoms of lung cancer. This is called symptom management.

Some people don’t have further treatment to get rid of the cancer cells. They only have treatment to manage their symptoms.

Doctors aren’t sure if having local consolidative treatment (LCT) alongside symptom management works any better than having symptom management alone. All treatments have side effects so doctors don’t want to give people treatment they don’t need.

The main aims of the study are to find out:

if having LCT alongside symptom management increases the length of time people live compared to having symptom management alone
how LCT treatment affects quality of life

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply. You:

have non small cell lung cancer (NSCLC)
have stage 4A or stage 4B lung cancer and you have completed your initial treatment
have had chemotherapy, targeted drug treatment or immunotherapy to treat your lung cancer. This treatment must have included at least 4 cycles of a platinum chemotherapy, at least 3 months of an approved targeted drug , at least 3 months of an immunotherapy or an immunotherapy in combination with chemotherapy. Your doctor will know this.
are suitable to have treatment to all the areas of residual disease you have. This treatment may include surgery, radiotherapy or ablation.
are fit and active but might not be able to work (performance status 0 or 1)
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply. You:

have had bad side effects from your initial treatment for advanced lung cancer. This means you wouldn’t be suitable to have further treatment with chemotherapy or targeted drugs.
are taking part in another trial that involves a treatment, the other trial team don’t think it’s suitable for you to join this study or it would be too much to take part in both trials.
are pregnant or breastfeeding
have any other serious medical condition that means you can’t have treatment to the cancer cells (localised treatment)

Trial design

This is a phase 3 study. The team need 244 people to take part. It is a randomised study. This means neither you nor your doctor can decide which treatment group you are in. There are 2 groups.

You have one of the following:

treatment to manage any symptoms of lung cancer (symptom management)
treatment which aims to get rid of all sites of disease (LCT) alongside treatment to manage any symptoms of lung cancer

RAMON study randomisation diagram

Local consolidative treatment (LCT) could include any of the following:

surgery
radiotherapy
treatment to heat and destroy cancer cells. This could include radiofrequency ablation or microwave ablation.

Your doctor will talk to you about the treatments and which ones they think will work best for you. You might have more than one type of treatment. This depends on where the areas of remaining disease are.

Your doctor will decide the most suitable treatment to manage your symptoms. This is treatment to relieve any symptoms you may have. This may include surgery to remove fluid from your chest to improve your breathing. Or you might have radiotherapy or ablation to your spine and bones if it is painful.

Both groups may also have long term cancer treatment if suitable. This isn’t part of this study. It is part of your routine care. Your doctor will talk to you about this if it applies to you.

Quality of life
The study team ask you to fill out some questionnaires:

before you start treatment
at set times during and after treatment

The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.

The researchers are also looking at running a sub study. They are looking at a mobile phone app to record quality of life. They’ll compare the information they get on the app with the information people give on the paper questionnaires. You don’t have to join the sub study if you don’t want to. It won’t affect you taking part in the rest of the study.

Hospital visits

You may have extra hospital visits if you have local consolidative treatment but this depends on which treatment you are having. The study team can tell you more about this and how often you need to go to hospital.

You might also have extra hospital visits for symptom management. But this is part of your routine care and not because you are taking part in this study.

Side effects

The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

The study doctor will talk to you about all the possible side effects of treatment. You will have a chance to ask them any questions you may have.

We have more information about the following treatments and their side effects: