Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 multicenter, randomized, placebo controlled, double-blind study to assess the safety and efficacy of CC-486 (oral azacitidine) in combination with pembrolizumab (MK-3475) versus pembrolizumab plus placebo in subjects with previously treated locally advanced or metastatic non-small cell lung cancer

This study is for people in the UK with advanced non-small cell lung cancer that has come back or spread after previous treatment. It’s a ‘Phase 2’ study, meaning researchers are gathering more information on how well a new combination treatment works and if it’s safe. Participants will receive either a tablet called azacitidine along with an existing drug called pembrolizumab, or pembrolizumab with a dummy pill (placebo). No one, not even the doctors, will know who is getting which treatment until the study ends. The main thing the researchers want to find out is whether the combination of drugs can stop the cancer from growing for longer. They will also look at side effects, overall survival, and how many people respond positively to the treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Celgene Corp.

Enrolment target

Start

05 Aug 2024

Second-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC)

What is this study about?

This research study is looking at a new way to treat a type of lung cancer called non-small cell lung cancer (NSCLC). This is a study for people whose cancer is advanced, meaning it has spread beyond where it started, or has come back after they've already had treatment for it. The study wants to see if adding a new drug, called azacitidine (which you take as a tablet), to an existing treatment, called pembrolizumab, works better than pembrolizumab alone.

The study is designed so that some people will get the azacitidine tablet along with pembrolizumab, and others will get a dummy pill (placebo) along with pembrolizumab. This means no one will know which treatment you are getting – not you, your doctor, or the study team – until the study is over. This is done to make sure the results are as fair and accurate as possible. The main goal is to see if the combination treatment can stop your cancer from growing or spreading for longer.

Researchers will also be closely watching for any side effects and how they might affect you. They will also measure how long people live overall and how many people's cancer shrinks or completely disappears with the treatments. This kind of study, called a 'Phase 2' study, helps researchers learn more about how safe and effective a new treatment is before it can be made widely available.

Key takeaways

Targets advanced non-small cell lung cancer that needs more treatment.
Compares a new drug combination to an existing treatment.
It's a 'blinded' study, so no one knows which treatment you are on.
Mainly looking to see if the new combination can stop cancer growth for longer.
Safety and side effects are also closely monitored.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, with a type of lung cancer called non-small cell lung cancer.

Your cancer needs to be advanced, meaning it has spread or come back after you've already had at least one other treatment for it. The study doctors will carefully check your medical history and current health to make sure it's safe for you to take part.

As with all clinical trials, there are specific health requirements or conditions that might mean you can't join. Your doctor, and the study team, will discuss all eligibility criteria with you in detail to see if this study is a good fit.

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 non-small cell lung cancer?
Has your lung cancer spread or come back after previous treatment?
Are you generally well enough to take part in medical treatments and regular check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be regularly monitored by the study team. You'll take your medication, which will either be the azacitidine tablet plus pembrolizumab, or a placebo tablet plus pembrolizumab. The pembrolizumab is usually given as an infusion.

You will have regular hospital visits for check-ups, blood tests, and scans to see how your cancer is responding. These visits will also be used to check for any side effects. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will be kept informed every step of the way.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment combination that could be more effective in controlling your cancer than standard options. However, there's no guarantee the treatment will work for you, and it might not improve your health. As with all medications, there's a risk of side effects, which could range from mild to serious. The study team will monitor you closely for any side effects and will explain all known risks. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What type of cancer is this study for?

This study is for adults with advanced non-small cell lung cancer that has been treated before.

What are the treatments being tested?

The study is comparing a combination of an azacitidine tablet with pembrolizumab, versus a placebo tablet with pembrolizumab.

What does 'placebo controlled' mean?

It means some people will get a dummy pill that looks like the real treatment, but contains no active drug, so researchers can fairly compare results.

Will I know which treatment I am getting?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are receiving until the study is over.

How long will I be in the study?

The duration of your participation will depend on how your cancer responds to treatment and your overall health. Your doctor can explain this in more detail.