RecruitingPHASE3INTERVENTIONAL

A Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

The REFINE-lung study is for people with advanced non-small cell lung cancer who are being treated with pembrolizumab (also known as Keytruda). After 6 months of standard treatment, if the cancer is under control and patients are planning to continue therapy, they might be offered the drug less frequently. The study wants to find out if giving pembrolizumab every 9, 12, 15, or even 18 weeks is as good as the usual 6-weekly schedule. This could mean fewer hospital visits, less impact on daily life, and potentially fewer side effects for patients. It could also help the NHS save money. If someone's cancer starts to grow again on a reduced schedule, they would be able to go back to the standard treatment.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Imperial College London

Enrolment target

1,750

Start

23 Jun 2022

Estimated completion

31 May 2027

Lung Cancer, Nonsmall Cell

What is this study about?

This study, called REFINE-lung, is looking at a common treatment for advanced lung cancer (specifically, non-small cell lung cancer), which uses a drug called pembrolizumab (you might know it as Keytruda). Pembrolizumab works by helping your body's immune system fight the cancer. It's usually given quite frequently over a long period, typically every 6 weeks for up to two years.

Doctors and researchers suspect that the current frequent dosing might be more than what's strictly needed for some patients. This is because the drug stays in your system for a long time, and studies haven't found a link between how much drug is given and how well it works. Many people who stop treatment still do well, suggesting that the body might not need constant top-ups.

So, this study will explore if giving pembrolizumab less often after the first 6 months of standard treatment is just as safe and effective. This could be a big step forward for patients, potentially leading to fewer hospital visits, less disruption to daily life, and possibly fewer side effects. It could also make this important treatment more affordable for the NHS.

Key takeaways

This study explores giving pembrolizumab less often for advanced non-small cell lung cancer.
It aims to see if less frequent doses are still safe and effective after 6 months of standard treatment.
Potential benefits include fewer hospital visits and possibly fewer side effects.
Participants will be randomly assigned to standard or reduced frequency treatment.
If your cancer progresses, you may return to the standard treatment schedule.

Who may be eligible?

To join this study, you must be at least 18 years old and have advanced non-small cell lung cancer. You need to have already been on pembrolizumab treatment (with or without chemotherapy) for 6 months, and your doctors must think the treatment is helping and that you should continue it. You also need to be willing to follow the study's plan.

There are some reasons why you wouldn't be able to join. For example, if your cancer has started to grow again (progressed) or you're not coping well with the treatment at the 6-month mark. You also can't join if your doctor doesn't plan for you to continue immunotherapy. If you have another primary cancer that's active, or if you're already trying another experimental drug or device, you wouldn't be eligible either.

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 advanced non-small cell lung cancer?
Have you been receiving pembrolizumab treatment for 6 months, and is it working for you?
Does your doctor plan for you to continue your immunotherapy treatment?
Do you feel comfortable following the study's plan?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have received 6 months of your usual pembrolizumab treatment. After that, if you're suitable, you'll be randomly assigned to either continue receiving pembrolizumab every 6 weeks (the standard) or to receive it less frequently, perhaps every 9, 12, 15, or 18 weeks. Which group you're in will be decided by chance, like flipping a coin. You'll still have regular check-ups and tests, just like you would with standard treatment, to see how you're doing and whether the treatment is still working.

If at any point your cancer starts to grow while you're on a less frequent schedule, the study doctors can talk to you about going back to the standard 6-weekly treatment. The total duration of your participation in the study will depend on how long your treatment is planned to continue, but your health will be monitored throughout.

Potential risks and benefits

Participating in this study might offer several potential benefits. There's a chance you could maintain the benefits of pembrolizumab with fewer hospital visits, less time spent in clinics, and possibly fewer side effects if your treatment frequency is reduced. However, there's always a possibility that receiving the drug less often might not be as effective for your cancer. If this happens, your doctors will discuss returning to standard treatment. As with all clinical trials, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (37)

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

Royal Bournemouth Hospital
Verified postcode
Bournemouth, United Kingdom· Recruiting
Royal Sussex County Hospital
Verified postcode
Brighton, United Kingdom· Recruiting
Bristol Haematology and Oncology Centre
Verified postcode
Bristol, United Kingdom· Recruiting
Queen's Hospital
Verified postcode
Burton-on-Trent, United Kingdom· Recruiting
Cambridge University Hospitals NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom· Not yet recruiting
East Kent Hospitals University NHS Foundation Trust
Verified postcode
Canterbury, United Kingdom· Recruiting
Velindre Cancer Centre
Verified postcode
Cardiff, United Kingdom· Recruiting
Colchester Hospital
Verified postcode
Colchester, United Kingdom· Recruiting
Royal Derby Hospital
Verified postcode
Derby, United Kingdom· Recruiting
NHS Lothian
Verified postcode
Edinburgh, United Kingdom· Recruiting
Royal Devon and Exeter Hospital
Verified postcode
Exeter, United Kingdom· Recruiting
Beatson West of Scotland Cancer Centre
Verified postcode
Glasgow, United Kingdom· Recruiting

Common questions

What is pembrolizumab (Keytruda)?

Pembrolizumab is a modern cancer drug that helps your own immune system find and fight cancer cells more effectively.

Why are they studying reduced treatment frequency?

Researchers believe that for some patients, the drug might stay active in the body longer than currently thought, meaning less frequent doses could still be effective while being more convenient.

Will I still get my regular check-ups if I receive treatment less often?

Yes, you will continue to have regular check-ups and tests, just like you would with standard treatment, to make sure the treatment is still working well for you.

What if my cancer gets worse on a reduced schedule?

If your cancer starts to grow, your doctors will discuss putting you back on the standard every-6-weeks treatment schedule.

Does this study involve new, experimental drugs?

No, this study is looking at different ways of giving pembrolizumab, which is already a standard and approved treatment for your type of lung cancer.

How to find out more

Alex Baker

a.williams@imperial.ac.uk 020 7594 2180 Official trial record

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