Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Multicenter, Randomized, Open-Label, Phase 1b/2 Trial of Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in Participants with Advanced or Metastatic Non-small Cell Lung Cancer whose Tumors Express PD-L1 with Tumor Proportion Score ≥50% Without Actionable Genomic Alterations

This research study is investigating new ways to treat advanced non-small cell lung cancer. It focuses on patients whose cancer has started to spread and has a particular protein marker (PD-L1 with a score of 50% or higher). Doctors are testing a new drug called Valemetostat Tosylate alongside a standard treatment, Pembrolizumab (also known as Keytruda). Some patients will receive both drugs, while others will receive only Keytruda. The study aims to see if the combination treatment is safe and more effective at stopping the cancer from growing. Researchers will carefully monitor participants' health, side effects, and how long they live without their cancer getting worse.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Daiichi Sankyo Inc.

Enrolment target

Start

29 Sep 2025

Advanced or Metastatic Non-Small Cell Lung Cancer

What is this study about?

This clinical trial is designed for people who have advanced non-small cell lung cancer. This means the cancer has spread beyond the lung where it started. Doctors are looking for better ways to treat this type of cancer.

The study involves a new drug, Valemetostat Tosylate, which is being tested in combination with a drug already used for advanced lung cancer, Pembrolizumab (also known as Keytruda). Keytruda helps your body's immune system fight cancer. The researchers want to find out if adding Valemetostat Tosylate to Keytruda is safe and if it works better than Keytruda on its own.

Participants in the study will be split into different groups by chance. Some will receive the new combination treatment, and others will receive only Keytruda. The main goals are to check for any side effects and to see how long people live without their cancer growing or spreading further. They will also look at how many people respond to the treatment and for how long. This study is divided into two parts; an early phase focusing on safety, and a later phase looking at how effective the treatment is.

Key takeaways

This study explores a new combination therapy for advanced lung cancer.
It's for people with a specific 'PD-L1' marker on their cancer.
The new drug Valemetostat Tosylate is combined with Keytruda.
The study aims to improve treatment and understanding of side effects.
Participation involves regular clinic visits and monitoring.
It’s a research study, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you would generally need to be an adult, at least 18 years old, and your gender doesn't matter for participation.

Your doctor would also need to confirm that you have advanced non-small cell lung cancer that has spread. A special test on your cancer cells must show a high level (50% or more) of a protein called PD-L1. This study is for people whose cancer doesn't have certain genetic changes that would make other specific treatments work better.

There might be other medical conditions or previous treatments that could mean you can't join the study, but your doctor will go through all the details if you are interested.

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 advanced non-small cell lung cancer?
Does your cancer have a high level (50% or more) of the PD-L1 marker?
Does your doctor say your cancer doesn't have certain genetic changes?
Are you generally well enough to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the new drug combination or Keytruda alone through an intravenous infusion (a drip into your arm). You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how your cancer is responding to the treatment. This will help doctors understand how well the drugs are working and if there are any side effects. The study will involve a period of active treatment and then continued follow-up to see the long-term effects. The total duration of participation will vary for each person depending on how their treatment progresses, but it is a commitment over a period of time.

Potential risks and benefits

Every medical treatment carries potential benefits and risks. The potential benefit of joining this study is that you might receive a new treatment that could be more effective for your lung cancer. However, there's no guarantee it will work for everyone, and like all medicines, the study drugs can cause side effects. These side effects can range from mild to serious. The study team will explain all known side effects before you decide to join. Remember, taking part in any clinical trial is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
France
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Unverified
Italy

Common questions

What kind of cancer is this study for?

This study is for people with advanced non-small cell lung cancer that has started to spread.

What drugs are being tested?

Doctors are testing a new drug called Valemetostat Tosylate with Pembrolizumab (Keytruda), and comparing it to Keytruda alone.

What does 'PD-L1 with a score of 50% or higher' mean?

This is a specific marker on your cancer cells that doctors look for. If your cancer has a high level of this marker (50% or more), you might be suitable for this study.

Will I definitely get the new drug combination?

No, participants are put into groups by chance. Some will get the combination, and others will get Keytruda on its own.

What will doctors be checking during the study?

They will mainly be checking for side effects and how long you live without your cancer getting worse.