Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase II, two-arm study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapy (INSIGHT 2 Study)

This study, called INSIGHT 2, is looking at a new way to treat non-small cell lung cancer that has spread or is advanced. It's for patients whose cancer has a specific genetic change (called an EGFR mutation and MET amplification) and has stopped responding to a medicine they were taking called osimertinib (also known as Tagrisso). The researchers want to see if combining tepotinib with osimertinib can help shrink the cancer. They will be carefully checking how well the treatment works and if there are any side effects. The aim is to find better ways to treat this type of lung cancer for people who have limited options.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Healthcare KGaA

Enrolment target

Start

08 Jul 2024

Lung Cancer

What is this study about?

This research study is for people in the UK who have a type of lung cancer called non-small cell lung cancer that has spread or is advanced. Specifically, it's for those whose cancer has certain genetic changes (called 'EGFR mutations' and 'MET amplification'). These changes can make the cancer grow. Many patients with these changes are first treated with a medicine called osimertinib (also known as Tagrisso). However, over time, the cancer can sometimes stop responding to this medicine.

This study is investigating if combining osimertinib with another drug called tepotinib can be an effective new treatment for this situation. Researchers want to see if this combination can help shrink the tumours or stop them from growing. They will carefully measure the cancer's response to the treatment, look at how long the benefit lasts, and track any effects on the patient's overall health and quality of life.

The main goal is to find out if this combination therapy can offer a new and better option for patients whose advanced lung cancer has developed resistance to their current treatment. This is a 'Phase II' study, which means it builds on earlier research and aims to confirm how well the treatment works and monitor its safety in a larger group of patients.

Key takeaways

This study is for advanced non-small cell lung cancer with specific genetic changes.
It tests a new combination of tepotinib and osimertinib.
It's for people whose cancer has stopped responding to osimertinib alone.
Researchers will monitor tumour changes, side effects, and quality of life.
The aim is to find new treatment options for this challenging type of cancer.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. Both men and women can take part.

You would be considered if you have advanced or metastatic non-small cell lung cancer. This means the cancer has spread beyond its original site or is in an advanced stage. Crucially, your cancer must have a specific genetic change called an 'EGFR mutation' and also show signs of 'MET amplification'.

Another important requirement is that your cancer must have previously been treated with osimertinib (Tagrisso) and shown signs of resistance, meaning it's no longer responding well to that treatment.

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 or metastatic non-small cell lung cancer?
Has your cancer been tested and found to have both an EGFR mutation and MET amplification?
Have you previously been treated with osimertinib (Tagrisso) for your lung cancer?
Has your cancer started to show signs of resistance to osimertinib?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking two different medications: osimertinib and tepotinib. You would take these tablets as prescribed by the study team. You would need to attend regular clinic visits for health checks, blood tests, and scans to monitor your health and how your cancer is responding to the treatment. The study team will explain the full schedule of visits and tests. The length of time you'd be on the study treatment can vary, depending on how you respond and if the treatment continues to be helpful for you.

Potential risks and benefits

Participating in this study might offer a potential benefit if the combination treatment works better than other options for your specific type of lung cancer, possibly helping to shrink your tumours or slow their growth. However, like all medicines, these drugs can have side effects, which could range from mild to serious. The study team will monitor you closely for any side effects and support you throughout. Remember, taking part in any clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Italy
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Unverified
France
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Unverified
Belgium
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Unverified
Germany
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Unverified
Spain

Common questions

What type of cancer is this study for?

It's for a specific type of advanced non-small cell lung cancer that has certain genetic changes and has stopped responding to osimertinib.

What drugs are being tested?

The study is testing a combination of two drugs: tepotinib and osimertinib (also known as Tagrisso).

Why are they studying these drugs together?

Researchers want to see if combining these two drugs can help shrink tumours in people whose cancer has become resistant to osimertinib alone.

What does 'Phase II' mean?

Phase II means the study is looking more closely at how well the treatment works and checking for side effects in a larger group of patients, following earlier safety tests.

Will I get to choose which drug I receive?

In this specific study, participants receive the combination of tepotinib and osimertinib. It's not designed to compare different treatments, but to see how well this particular combination works.