Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Pembrolizumab Alone versUs pembrolizumab-chemotherapy in first LInE NSCLC (PAULIEN)

This study, called PAULIEN, is for people with advanced non-small cell lung cancer (NSCLC) who are starting treatment for the first time. We want to see if combining a drug called pembrolizumab (also known as KEYTRUDA) with chemotherapy medicines (like Pemetrexed, Carboplatin, and Paclitaxel) is more effective than using pembrolizumab by itself. We'll be looking carefully at how many people's tumours shrink or stop growing after six weeks of treatment. We'll also be tracking how long people live, how long it takes for the cancer to get worse, and any side effects. This is a Phase 3 study, meaning it's a final step to confirm if a new treatment approach is better.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Stichting Amsterdam UMC

Enrolment target

Start

08 Nov 2024

Advanced stage NSCLC

What is this study about?

This research study, named PAULIEN, is looking into the best way to treat a type of lung cancer called advanced non-small cell lung cancer (NSCLC). This is when the cancer has spread beyond the lung where it started. For people starting their first treatment for this kind of cancer, doctors want to find out if giving a drug called pembrolizumab alongside standard chemotherapy medicines is more helpful than giving pembrolizumab on its own.

Pembrolizumab works by helping your body's immune system fight the cancer. Chemotherapy uses strong medicines to kill cancer cells. By comparing these two treatment approaches, the study hopes to understand which one is better at controlling the cancer, shrinking tumours, and helping people live longer and feel better.

Researchers will be carefully tracking how patients respond to treatment. After six weeks, they'll check if the tumours have shrunk or stopped growing. They will also look at how long it takes for the cancer to progress, and how long people live overall. Importantly, they will also be monitoring any side effects that people experience from the treatments to understand the safety of each approach.

Key takeaways

This study compares two lung cancer treatments for advanced NSCLC.
It's for people starting their very first treatment for this condition.
One group gets pembrolizumab, the other gets pembrolizumab plus chemotherapy.
The main goal is to see which treatment shrinks tumours or stops them growing better.
Researchers will also track survival rates and side effects.
It's a large, important study (Phase III) to find better treatment options.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. The study is open to both men and women.

You would be eligible if you have advanced non-small cell lung cancer (NSCLC) and are about to start your very first treatment for it. The doctors running the study will check other medical details to make sure this is the right study for you.

There might be other health conditions or medications that would mean you can't join, but the study team will go through all of this with you in detail.

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 (NSCLC)?
Are you about to start your first ever treatment for this type of cancer?
Are you willing to be randomly assigned to one of two treatment groups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to one of two treatment groups: either you would receive pembrolizumab on its own, or you would receive pembrolizumab alongside chemotherapy medicines (Pemetrexed, Carboplatin, and Paclitaxel). This assignment is random, like flipping a coin. You wouldn't get to choose which group you're in.

You would have regular visits to the hospital or clinic for your treatments and check-ups. These visits would involve doctors examining you, blood tests, and scans (like CT scans) to see how the treatment is working and to monitor your health. The treatments would continue for a set period, and doctors would check on you regularly even after your main treatment finishes, to see how you're doing over time. The total duration of your involvement could be several years, following your health from the start until the very end of the study.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of receiving new or advanced treatments for your cancer. However, there are also potential risks involved. The medications used can cause side effects, which the study team will monitor closely. These could range from mild to more serious, and the study will be collecting all information on these. You'll be given detailed information about all possible side effects. It's very important to remember that joining a study is always volunteer-based, and you are free 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
Netherlands

Common questions

What is 'advanced non-small cell lung cancer'?

This means your lung cancer has spread to other parts of your body, beyond where it first started in your lung.

What is pembrolizumab (KEYTRUDA)?

It's a type of medicine that uses your body's own immune system to help fight cancer cells.

What is chemotherapy?

Chemotherapy uses strong medicines to kill fast-growing cells, including cancer cells.

Why are two different treatments being compared?

The study wants to find out if combining pembrolizumab with chemotherapy works better than pembrolizumab alone for your type of cancer.

What does 'Phase III' mean for this study?

This means it's a final, large-scale study designed to confirm if a new treatment is truly effective and safe compared to existing options.