Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)

This study, called KEYNOTE-867, is for people in the UK with early-stage non-small cell lung cancer that doctors haven't removed with surgery. It aims to see if adding the drug Pembrolizumab (Keytruda) to a special type of radiation therapy called SBRT is safer and more effective than SBRT alone. Researchers want to find out if this combination can stop the cancer from coming back or spreading for longer. They'll also be looking at how long people live, if their cancer spreads to other parts of the body, and how the treatment affects their quality of life, including symptoms like cough and chest pain. This is a Phase 3 study, meaning it's a large trial to confirm the benefits and safety of this new approach compared to standard care.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme Corp.

Enrolment target

243

Start

27 Jan 2023

Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC)

What is this study about?

This clinical trial is designed for people who have been diagnosed with early-stage non-small cell lung cancer (NSCLC) that doctors haven't been able to remove with surgery. In this study, doctors are investigating a new way to treat this type of cancer by combining two existing treatments.

One part of the treatment is called Stereotactic Body Radiotherapy, or SBRT. This is a very precise type of radiation therapy that delivers high doses of radiation directly to the tumour while trying to protect healthy tissue nearby. The other part involves a drug called Pembrolizumab, also known as Keytruda. This is a type of immunotherapy, which works by helping your body's own immune system fight the cancer. Some participants will receive SBRT with Keytruda, while others will receive SBRT with a look-alike dummy medicine (placebo).

The main goal of this study is to see if combining SBRT with Keytruda can help people live longer without their cancer coming back or getting worse. The researchers will also be closely watching other things, like how long people live overall, whether the cancer spreads to other parts of the body, and how the treatment affects participants' daily lives and well-being. This includes looking at symptoms like tiredness, breathing difficulties, cough, and chest pain, which are measured using special questionnaires.

Key takeaways

This study combines targeted radiation (SBRT) with an immune-boosting drug (Keytruda) for early lung cancer.
It's for people with Stage I or II non-small cell lung cancer that cannot be removed by surgery.
The main goal is to see if this combination stops cancer from returning or spreading sooner.
You might receive Keytruda or a dummy drug (placebo) alongside SBRT.
Your quality of life and side effects will be closely monitored.
Participation involves regular hospital visits for treatment, tests, and check-ups.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. Both men and women can take part.

Critically, you must have been diagnosed with non-small cell lung cancer that is considered 'Stage I' or 'Stage II'. This means it's an early-stage cancer that hasn't spread widely. Crucially, your doctors must have decided that your cancer cannot be removed by surgery.

There will be other detailed medical checks to make sure the treatment is safe for you and that you meet all the study requirements. Your doctor will discuss these with you.

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?
Have you been diagnosed with Stage I or II non-small cell lung cancer?
Has your doctor told you that your cancer cannot be removed by surgery?
Are you able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups. One group will receive SBRT radiation therapy plus the study drug Keytruda, while the other group will receive SBRT plus a placebo (a dummy medicine that looks like Keytruda). This is done by chance, like flipping a coin, so neither you nor your doctor can choose which group you are in. You will receive the SBRT treatment first, followed by a course of the study drug or placebo given through a drip into your arm.

Participation will involve regular visits to the hospital for examinations, blood tests, and scans to monitor your health and how the treatment is working. You will also fill out questionnaires about your symptoms and quality of life. The total duration of the treatment phase and follow-up will be discussed by the study team, but typically, these types of studies involve consistent monitoring over several years to track long-term health outcomes.

Potential risks and benefits

Potential benefits of taking part in this study include receiving a new combination treatment that might be more effective than SBRT alone for your type of lung cancer. You would also receive close medical attention and monitoring throughout the study. However, there are potential risks, as with any medical treatment. Keytruda can cause side effects, which vary from person to person and can range from mild to serious, including immune-related reactions. SBRT also has its own set of potential side effects. The study team will provide you with a full list of known side effects. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (10)

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

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Unverified
Germany
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Unverified
Netherlands
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Unverified
Norway
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Unverified
Spain
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Unverified
Hungary
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Unverified
Italy
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Unverified
France
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Unverified
Austria
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Unverified
Poland
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Unverified
Romania

Common questions

What is SBRT?

SBRT is a highly precise type of radiation therapy that delivers strong doses of radiation directly to the tumour, aiming to protect the surrounding healthy tissues.

What is Keytruda (Pembrolizumab)?

Keytruda is an immunotherapy drug that helps your body's own immune system find and fight cancer cells more effectively.

Why is a 'placebo' used?

A placebo is a dummy drug that looks like the real medicine. It helps researchers compare the effects of the actual drug against what happens without it, to truly understand if the drug is working.

What does 'early-stage non-small cell lung cancer' mean?

This means your lung cancer is localised and hasn't spread widely to other parts of your body, falling into what doctors call Stage I or Stage II.

How long will the study last?

While the active treatment phase might be shorter, participants are typically followed for several years to track long-term health outcomes and side effects. The study team will give you a clear timeline.