Active not recruitingPHASE2INTERVENTIONAL

A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)

This study, called INSIGHT 2, investigated a new treatment approach for people with advanced non-small cell lung cancer where their initial treatment with osimertinib had stopped working. Researchers combined two medicines, tepotinib and osimertinib, to see if they could effectively target a specific change in the cancer cells called 'MET amplification'. The main goals were to understand how well this new combination could shrink tumours, what side effects people experienced, and how the body processed these drugs. This trial is in an early stage (Phase 2), meaning it's still gathering information on how effective and safe this treatment might be for people with this particular type of lung cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

EMD Serono Research & Development Institute, Inc.

Enrolment target

140

Start

19 Sep 2019

Estimated completion

01 May 2026

Non-small Cell Lung Cancer

Results

Results from this study

Posted June 2024

Results have been published for this study.

Primary outcome

Combined Therapy (Tepotinib+Osimertinib): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version (NCI-CTCAE v 5.0)

DLTs are defined as any of the following toxicities and judged by the Investigator and/or the Sponsor to be not attributable to the disease or disease-related processes under investigation: Grade 4 neutropenia for more than 7 days; Grade greater than or equal to (\>=) 3 febrile neutropenia; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with non-traumatic bleeding; Grade \>= 3 nausea/vomiting and/or diarrhea that has not improved within 72 hours despite adequate and optimal treatment; Any other Grade \>= 3 non-hematological AE, except alopecia or Grade 3 nauseas/vomiting and/or diarrhea that has improved within 72 hours with optimal treatment.

Full results on the registry

What is this study about?

This study, known as INSIGHT 2, is looking at a new way to treat a specific type of lung cancer called non-small cell lung cancer (NSCLC). This is the most common type of lung cancer. Sometimes, after people have been treated with a medicine called osimertinib, their cancer starts to grow again. This study is for people in that situation, particularly if their cancer cells show a specific change known as 'MET amplification'.

The researchers are combining osimertinib with another medicine called tepotinib. Both drugs work by targeting certain pathways that help cancer cells grow. The idea is that by using them together, they might be more effective at stopping the cancer from growing, especially when it has developed this 'MET amplification' change. This is a Phase 2 study, which means it builds on earlier research and aims to learn more about how well the treatment works, if it's safe, and how the body handles the drugs.

The main goal is to see if this combination can shrink the tumours or stop them from growing further, and to understand any side effects people might experience. If successful, studies like this can lead to new treatment options for people living with this type of lung cancer.

Key takeaways

This study tests a new combination treatment for advanced lung cancer.
It's for people whose initial osimertinib treatment stopped working.
Your cancer must have a specific change called 'MET amplification'.
The combination involves two drugs: tepotinib and osimertinib.
It's a Phase 2 study, looking at effectiveness, safety, and how the body uses the drugs.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to be an adult (18 or older) with advanced non-small cell lung cancer that has spread.

Your cancer must have a specific 'EGFR mutation' and you must have already been treated with osimertinib as your first treatment, but your cancer has since started to grow again. Importantly, your cancer cells must also show a change called 'MET amplification'. You would need to be feeling well enough to take part, with a good quality of life and no severe existing health issues that could interfere with the study.

There are also some reasons why you might not be able to join, such as having certain unmanaged brain tumours or spinal cord problems, or if you still have severe side effects from previous cancer treatments. The study doctors will talk through all these details with you to see if it's the right fit.

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 non-small cell lung cancer?
Did your cancer worsen after first being treated with osimertinib?
Do your cancer cells show a 'MET amplification' change?
Are you generally feeling well enough to participate?
Have you not received any other treatments for advanced lung cancer besides osimertinib?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be taking a combination of tepotinib and osimertinib. The study team would closely monitor your health with regular check-ups, blood tests, and scans to see how well the treatment is working and to identify any side effects. You would need to provide samples, including tumour tissue and blood, for specific tests to ensure your cancer has the 'MET amplification' required for the study.

The overall length of your participation would depend on how your cancer responds to the treatment and your general health, but you would be regularly assessed by the study team. You would also have follow-up appointments even after stopping the study treatment.

Potential risks and benefits

Taking part in a clinical trial offers the chance to try a new treatment combination that might help control your cancer where previous treatments haven't. However, as with all medicines, there's no guarantee the treatment will work for everyone, and you might experience side effects, some of which could be serious. The study team will carefully explain all known potential side effects. Remember, joining is entirely voluntary, and you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (179)

Yuma Regional Medical Center
Verified postcode
Yuma, United States
Compassionate Care Research Group Inc - Edinger Medical Group, Inc.
Verified postcode
Fountain Valley, United States
Memorial Care
Verified postcode
Long Beach, United States
Ventura County Hematology Oncology Specialists
Verified postcode
Oxnard, United States
Innovative Clinical Research Institute
Verified postcode
Whittier, United States
Eastern Connecticut Hematology & Oncology Associates
Verified postcode
Norwich, United States
Holy Cross
Verified postcode
Fort Lauderdale, United States
Memorial Healthcare System
Verified postcode
Hollywood, United States
Cancer Specialists of North Florida
Verified postcode
Jacksonville, United States
Ocala Oncology
Verified postcode
Ocala, United States
University Cancer and Blood Center
Verified postcode
Athens, United States
Hawaii Cancer Care
Verified postcode
Honolulu, United States

Common questions

What is 'MET amplification'?

It's a specific change in your cancer cells that can make them grow more. This study focuses on treatments that target this change.

What is a Phase 2 study?

It means this study is an early stage of research. It aims to see if a new treatment works and is safe, building on findings from earlier, smaller studies.

Why combine two drugs?

Sometimes, combining drugs that target cancer in different ways can be more effective than using just one. This study is testing if this is true for tepotinib and osimertinib.

Will I get a placebo (dummy drug)?

No, this study does not mention a placebo group. Everyone participating would receive the study drugs.

How long will I be on the treatment?

You would continue treatment as long as it is working for you and you are not having serious side effects. Your doctor will discuss this with you regularly.