Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

KEYMAKER-U01 Master Study: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents with either Pembrolizumab in Combination with Chemotherapy or with Pembrolizumab Alone in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) KEYMAKER-U01 Substudy 3: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated with anti-PD-(L)1 Therapy

This research is like a 'master study' with several smaller parts, all looking for new ways to treat advanced non-small cell lung cancer. Specifically, one part of the study is for people whose cancer has already been treated with a common type of immunotherapy (anti-PD-1 or anti-PD-L1 therapy). Researchers are testing new experimental drugs, sometimes alongside an existing medicine called Pembrolizumab (KEYTRUDA®), or Pembrolizumab on its own. The main goal is to see if these new treatments can shrink tumours. They'll also check how long people live without their cancer getting worse, and look for any side effects. This is a Phase 2 study, meaning it's still in the earlier stages of testing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

16 Jan 2024

Non-small Cell Lung Cancer

What is this study about?

This study, called KEYMAKER-U01, is a big research project divided into smaller, connected studies. The overall aim is to find new and more effective treatments for advanced non-small cell lung cancer. This particular part of the study (Substudy 3) is focused on individuals whose lung cancer has advanced even after they've already received a specific type of immunotherapy. Immunotherapy helps your body's immune system fight cancer, and anti-PD-(L)1 therapies are a common type of this treatment.

The researchers are testing several new, experimental medicines. Some people in the study will receive one of these new drugs along with Pembrolizumab (also known as KEYTRUDA®), which is a well-known immunotherapy. Others might receive Pembrolizumab by itself. The main thing the doctors want to find out is how many people experience their tumours shrinking after receiving these treatments. This is an important step to see if these new approaches could become future standard treatments.

Beyond simply shrinking tumours, the study will also look at how long people live before their cancer starts to grow again or spread, which is known as 'progression-free survival'. They will also carefully monitor any side effects that people experience, as safety is always a top priority in medical research. This is a 'Phase 2' study, which means it’s still in the relatively early stages of testing these new treatments, aiming to gather more information about how well they work and how safe they are.

Key takeaways

The study tests new treatments for advanced non-small cell lung cancer.
It's for people whose cancer hasn't responded to previous immunotherapy.
Treatments include new drugs, sometimes with Pembrolizumab (KEYTRUDA®).
The main aim is to see if tumours shrink and monitor for side effects.
Participation involves regular hospital visits, tests, and medication.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part. You must have advanced non-small cell lung cancer that has continued to grow despite having received prior treatment targeting an immune pathway (anti-PD-(L)1 therapy). Your doctors will need to review your medical history and current health carefully to make sure this study is right for you. They will check things like your overall health, other medications you are taking, and how well your organs are working.

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?
Has your cancer been previously treated with anti-PD-(L)1 immunotherapy?
Are you generally well enough to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have regular hospital visits for check-ups, blood tests, and scans (like CT or MRI scans) to monitor your cancer and your general health. You will receive the study medication, which may be given as an infusion (through a drip into your vein) or as tablets, depending on the specific treatment. The frequency of visits and how you receive the treatment will vary depending on which study treatment you are assigned. You'll be closely monitored for any side effects. Your participation in the study would continue as long as the treatment is helping you and you are not experiencing severe side effects, or for a set period as determined by the study design. There will also be follow-up appointments after you stop receiving the study treatment.

Potential risks and benefits

Taking part in a clinical trial means you might benefit from a new treatment that isn’t yet widely available, and you would be contributing valuable information to help others in the future. However, there's no guarantee that the treatment will work for you, and like all medicines, the study drugs have potential side effects, which can range from mild to serious. The research team will explain all known side effects and monitor you very closely. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Hungary
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Unverified
Italy
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Unverified
Spain
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Unverified
Poland

Common questions

What kind of cancer is this study for?

This study is for people with advanced non-small cell lung cancer that has already been treated with a specific type of immunotherapy.

What types of treatments are being tested?

The study is testing new, experimental drugs, sometimes along with an existing immunotherapy called Pembrolizumab (KEYTRUDA®), or Pembrolizumab on its own.

What is a Phase 2 study?

Phase 2 studies are early stages of testing new treatments. They aim to see how well a treatment works and gather more information about its safety, usually in a larger group of people than a Phase 1 study.

What is the main goal of the study?

The main goal is to see if the new treatments can shrink tumours. Researchers will also look at how long people live without their cancer getting worse and check for any side effects.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason. Your decision will not affect your regular medical care.