Active not recruitingPHASE1INTERVENTIONAL

POTENT - Tepotinib in Combination With Pembrolizumab in NSCLC

This study is testing two drugs, tepotinib and pembrolizumab, together for people with advanced non-small cell lung cancer. Pembrolizumab (also known as Keytruda) is a type of immunotherapy drug already used for many cancers. Tepotinib is used for a specific type of lung cancer. Immunotherapy drugs work by helping your immune system fight cancer, but they don't work for everyone, especially if the cancer is good at hiding from the immune system. This study aims to see if tepotinib can help make these 'hidden' cancers more visible and responsive to pembrolizumab. Researchers want to find out if this combination could offer a new way to treat lung cancer that hasn't responded to other treatments.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

Start

03 May 2023

Estimated completion

09 Jan 2029

Advanced Cancer Non Small Cell Lung Cancer

What is this study about?

This clinical study is looking into a new way to treat advanced non-small cell lung cancer by combining two medications: tepotinib and pembrolizumab. Pembrolizumab, also known as Keytruda, is an approved drug often used to help your body's immune system fight various cancers. Tepotinib is another drug that is already approved for a specific type of non-small cell lung cancer in the UK.

While immunotherapy drugs like pembrolizumab show great promise, they don't work for all patients. Sometimes, cancer cells are very good at hiding from the body's immune system, meaning the immunotherapy can't 'see' them to attack. This study explores whether tepotinib can help reveal these hidden cancer cells, making them more vulnerable to the effects of pembrolizumab. Tepotinib works by blocking certain signals within cancer cells that cause them to grow, especially in cancers with specific changes in a gene called MET. By targeting this gene, tepotinib may help slow or stop cancer growth.

The main idea behind this study is to test if this combination of drugs can be effective for people whose cancers haven't responded well to immunotherapy before. It's an early-stage study, meaning it will involve a small group of people to see how safe and effective this new approach might be.

Key takeaways

This study combines two drugs (tepotinib + pembrolizumab) for advanced lung cancer.
It aims to make 'hidden' cancers more responsive to immunotherapy.
Tepotinib targets a specific gene change (MET) that can drive cancer growth.
It's an early-stage study for people whose cancer hasn't responded to previous immunotherapy.
Participation involves close monitoring and access to new, experimental treatments.

Who may be eligible?

To join this study, you need to be at least 18 years old and have non-small cell lung cancer that has been confirmed by a doctor. The study is divided into different groups, and your eligibility might depend on specific features of your cancer.

For some parts of the study, you might need to have a particular change in your cancer's MET gene. You might also be eligible if you haven't received immunotherapy before, or if your cancer has progressed despite receiving at least two cycles of immunotherapy. You'll also need to be generally well, with a life expectancy of at least 12 weeks, and have good results from certain blood tests.

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 at least 18 years old?
Do you have confirmed non-small cell lung cancer?
Do you have good general health and acceptable blood test results?
Have you discussed your MET gene status with your doctor?
Has your cancer progressed despite receiving previous immunotherapy?

Answer every question to see your result.

What does participation involve?

The detailed requirements for participating in this study would be fully explained by the study team. Generally, taking part in a clinical trial involves a series of visits to the hospital or clinic for assessments, which typically include physical examinations, blood tests, and scans to monitor your health and the cancer's response to treatment. You would receive the study medications (tepotinib and pembrolizumab) according to a specific schedule decided by the researchers. The length of time you'd be in the study, including follow-up visits after stopping treatment, would be clearly outlined before you agree to participate.

Potential risks and benefits

Participating in this study might offer the potential benefit of accessing a new treatment combination that could help slow or shrink your cancer, especially if other treatments haven't worked well. However, all medical treatments carry potential risks and side effects, and these experimental drugs might have unknown effects. The study team will explain all known side effects and what to look out for. You would receive careful monitoring throughout the study to manage any side effects. It's important to remember that joining a clinical trial is always voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (4)

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

DDU, Royal Marsden Hospital NHS Foundation Trust
Verified postcode
Sutton, United Kingdom
University College London Hospitals NHS Foundation Trust
Verified postcode
London, United Kingdom
Lung Unit, Royal Marsden Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom

Common questions

What is non-small cell lung cancer?

Non-small cell lung cancer is the most common type of lung cancer. It's called 'non-small cell' because of how the cancer cells look under a microscope.

What is immunotherapy?

Immunotherapy is a type of treatment that helps your body's own immune system fight cancer. It works by boosting or changing how your immune system works.

What is the MET gene?

The MET gene is a part of your DNA. Sometimes, changes in this gene can make cancer cells grow out of control. Tepotinib is designed to block the effects of these changes.

Will I know if I'm getting the active drugs?

Yes, in this study, all participants will receive both tepotinib and pembrolizumab. This is not a study where some people get a placebo (dummy drug).

What does 'advanced cancer' mean?

Advanced cancer usually means the cancer has spread beyond where it started or cannot be completely removed by surgery. This study is for people with advanced non-small cell lung cancer.