Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

10 criteria

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 trial?

12 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Azienda Unita Sanitaria Locale Della Romagna
Verified
Faenza, Italy
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

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.

What is already known about the treatment

Valemetostat Tosylate
An investigational drug administered orally that belongs to the class of EZH1/2 dual inhibitors, currently being studied in clinical trials for advanced or metastatic non-small cell lung cancer. This medication works by targeting and inhibiting specific enzymes (EZH1 and EZH2) that are involved in epigenetic regulation of gene expression, potentially helping to control cancer cell growth. The drug is being evaluated in combination with pembrolizumab to potentially enhance the effectiveness of immunotherapy in patients whose tumors express PD-L1.
Pembrolizumab
An FDA-approved immunotherapy medication administered through intravenous infusion that belongs to the class of PD-1 inhibitors, used in the treatment of various cancers including non-small cell lung cancer. This medication works by blocking the PD-1 pathway, helping the immune system recognize and attack cancer cells more effectively. Pembrolizumab has become a standard first-line treatment option for patients with advanced non-small cell lung cancer whose tumors express high levels of PD-L1.

Investigated diseases

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.