Study comparing valemetostat tosylate plus pembrolizumab versus pembrolizumab alone in patients with advanced non-small cell lung cancer with high PD-L1 expression

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What is this study about?

This study focuses on Non-Small Cell Lung Cancer that has spread to other parts of the body (advanced or metastatic). The research evaluates two medications: pembrolizumab (also known as KEYTRUDA), which is given through an infusion into a vein, and valemetostat tosylate, which is taken as a tablet by mouth. The purpose is to determine if using these two medications together works better than using pembrolizumab alone.

The study consists of two parts. The first part tests the safety of combining the medications and determines the right dose. The second part compares how well the combination of medications works versus using just pembrolizumab by itself. The study includes patients whose cancer cells have high levels of a protein called PD-L1 and who have not received previous treatment for their advanced cancer.

During the study, participants will be randomly assigned to receive either the combination of both medications or pembrolizumab alone. The medications will be given in repeated cycles, with regular check-ups to monitor the patient’s health and how well the treatment is working. Doctors will use various medical tests and imaging scans to track the progress of the cancer throughout the treatment period.

1 Initial qualification

You will undergo screening tests to confirm your eligibility for the trial, including verification that your non-small cell lung cancer (NSCLC) is at an advanced stage

Your tumor tissue will be tested to check for specific genetic markers and PD-L1 expression levels

A physical examination will be performed to assess your overall health status

2 Assignment to treatment group

You will be randomly assigned to one of two treatment groups:

Group 1: Treatment with pembrolizumab (Keytruda) alone, given as an infusion into your vein

Group 2: Treatment with pembrolizumab plus valemetostat tosylate tablets taken by mouth

3 Treatment phase

If assigned to Group 1: You will receive pembrolizumab through an intravenous infusion

If assigned to Group 2: You will receive both pembrolizumab infusion and valemetostat tosylate tablets

Regular assessments will be performed to monitor your response to treatment and any side effects

4 Monitoring and evaluation

Your cancer will be monitored through regular CT or MRI scans to assess how the treatment is working

Blood tests and physical examinations will be conducted to monitor your health

Any side effects or changes in your condition will be documented

5 Follow-up period

After completing the treatment phase, you will continue to be monitored through regular follow-up visits

The trial is expected to continue until April 2030

Long-term monitoring will assess your overall health status and the effectiveness of the treatment

Who Can Join the Study?

Must be at least 18 years of age or above the minimum legal age in your country
Must sign an informed consent form before any study procedures begin
Must have confirmed non-small cell lung cancer (NSCLC) that:
- Has not been previously treated with systemic therapy (medications that travel through the bloodstream)
- Is at an advanced stage (Stage IIIB, IIIC, or IV) and cannot be treated with surgery
- Tests negative for specific genetic changes (EGFR, ALK, and ROS1)
Must have tumors that can be measured using CT or MRI scans
Must have tumors that test positive for a protein called PD-L1 at a level of 50% or higher
Must provide a tumor tissue sample for laboratory testing. If an old sample is not available, a new biopsy may be required if medically safe
Must have good physical function, rated as ECOG Performance Status of 0 or 1 (able to perform daily activities with minimal assistance)
Both men and women may participate in the study

Who Cannot Join the Study?

Prior treatment with any EZH2 inhibitor (a type of targeted cancer therapy)
Active brain metastases (cancer that has spread to the brain) or spinal cord compression that is not adequately treated
History of severe allergic reactions to monoclonal antibodies (a type of targeted therapy)
Active autoimmune disease requiring systemic treatment
Current use of immunosuppressive medication (drugs that lower immune system activity)
Active infection requiring systemic therapy
Known history of HIV, active hepatitis B, or active hepatitis C infection
Significant heart conditions within the past 6 months
Pregnant or breastfeeding women
Any other serious medical condition that could interfere with study participation
Participation in another clinical trial within 30 days before starting this study
Known psychiatric or substance abuse disorders that would interfere with study requirements

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Hospital Arnau De Vilanova De Valencia	Valencia	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Aaimylcply Ptgimllb Hzcaegqn Da Mkypbozps	Marseille	France
Fdarqspxo Pnth Lx Ihiqbokcfwvsy Bzndikuuj Dla Hooosgjb Uvvpdkonockbb Lm Pzi	Madrid	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	15.10.2025
Italy	Not recruiting	15.10.2025
Spain	Not recruiting	15.10.2025

Trial locations

Investigated drugs:

Pembrolizumab

Valemetostat Tosylate is a medication being studied for treating advanced or metastatic non-small cell lung cancer. It belongs to a class of drugs that work by affecting how genes are expressed in cancer cells. This medication is being tested as a new treatment option for patients whose cancer has specific characteristics.

Pembrolizumab is an immunotherapy medication that helps the body’s immune system fight cancer cells. It works by blocking a protein called PD-L1, which cancer cells use to hide from the immune system. This medication is already approved for treating various types of cancer, including lung cancer, and is being studied both alone and in combination with valemetostat tosylate.

Investigated diseases:

Non-small cell lung cancer metastatic

Non-Small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the cells of the lungs and can spread to other parts of the body. It develops when healthy cells in the lung tissue change and grow uncontrollably, forming a mass called a tumor. NSCLC typically grows and spreads more slowly than small cell lung cancer. Advanced or metastatic NSCLC means the cancer has spread beyond the lungs to other parts of the body. The disease accounts for about 85% of all lung cancers and includes several subtypes, with adenocarcinoma and squamous cell carcinoma being the most common.

Trial ID:

2024-519671-26-00

Protocol code:

DS3201-330

NCT ID:

NCT06644768

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study comparing valemetostat tosylate plus pembrolizumab versus pembrolizumab alone in patients with advanced non-small cell lung cancer with high PD-L1 expression

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?