Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

This study is investigating a new treatment approach for a type of lung cancer known as non-small cell lung cancer, which has spread and cannot be removed by surgery. The treatment involves a combination of two medicines, amivantamab and capmatinib. The first part of the study aims to find the safest and most effective dose when these two drugs are given together. The second part will then look at how well this combination therapy shrinks tumours in patients whose cancer has specific changes in their genes, called MET exon 14 skipping mutation and MET amplified NSCLC. This trial hopes to find a better treatment option for these patients.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

Start

13 Dec 2022

Estimated completion

28 Apr 2027

Carcinoma, Non-Small-Cell Lung

What is this study about?

This research study is about finding a new and potentially better way to treat a type of lung cancer called non-small cell lung cancer. This particular type of cancer has spread to other parts of the body (metastatic) and cannot be removed through surgery (unresectable). The study focuses on using two different medicines, amivantamab and capmatinib, at the same time.

The study has two main parts. In the first part, the doctors are carefully testing different amounts of the two medicines given together. Their goal is to find the best and safest combination dose that can then be used in the second part of the study. This is important to make sure patients receive treatment that is both effective and has manageable side effects.

In the second part of the study, after the best dose is found, researchers will look at how well this combined treatment actually works. They are particularly interested in patients whose lung cancer has specific genetic changes, sometimes called 'MET mutations'. By combining these two medications, the researchers hope to find a new and more effective way to treat these specific types of non-small cell lung cancer.

Key takeaways

This study is for advanced non-small cell lung cancer that cannot be surgically removed.
It tests a new combination of two medicines: amivantamab and capmatinib.
The first stage aims to find the safest and most effective dose.
The second stage checks how well the treatment shrinks tumours, especially for specific gene changes.
Participation involves regular hospital visits for treatment and health checks.

Who may be eligible?

To be part of this study, you would generally need to have been diagnosed with non-small cell lung cancer that has spread and can't be surgically removed. It's important that your overall health is good enough to participate, as measured by a doctor, and you might have had other health conditions as long as they wouldn't interfere with the study treatments or results.

There are also certain reasons why you might not be able to join. For example, if you have a lung condition called interstitial lung disease, or if you have severe issues with your stomach or gut that would stop you from taking one of the study medicines. Also, if you have unstable brain tumours or severe pain that hasn't been managed, you might not be able to take part.

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.

Do you have non-small cell lung cancer that has spread and can't be operated on?
Is your overall health generally good enough for a clinical study?
Do you have a negative pregnancy test if you could become pregnant?
Do you *not* have a severe ongoing lung condition like interstitial lung disease?
Are you able to swallow tablets or have normal gut function?
Are any brain tumours stable and not requiring high doses of steroids?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital. During these visits, doctors and nurses will check your health, give you the study medication (amivantamab and capmatinib), and perform tests like blood samples and scans to see how you are responding to the treatment. These tests help the doctors understand if the medication is working and if there are any side effects. You will continue to take the medication and have these check-ups for as long as the treatment is beneficial and safe for you. The total duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Through this study, you might benefit from receiving new treatments that aren't widely available yet, which could help manage your cancer. However, like all medicines, these treatments can have side effects, and they might not work for everyone. These side effects will be carefully monitored by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (78)

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

University of Alabama at Birmingham, Comprehensive Cancer Center
Verified postcode
Birmingham, United States
The Oncology Institute of Hope and Innovation
Verified postcode
Cerritos, United States
UCLA
Verified postcode
Los Angeles, United States
Montefiore Einstein Center for Cancer Care
Verified postcode
The Bronx, United States
Virginia Cancer Specialists
Verified postcode
Fairfax, United States
PERSONAL Oncologia de Precisao e Personalizada
Verified postcode
Belo Horizonte, Brazil
CIONC Centro Integrado de Oncologia de Curitiba
Verified postcode
Curitiba, Brazil
UPCO Unidade de Pesquisa Clinica em Oncologia
Verified postcode
Pelotas, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Verified postcode
Porto Alegre, Brazil
Oncoclinicas Rio de Janeiro S A
Verified postcode
Rio de Janeiro, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
Verified postcode
Rio de Janeiro, Brazil
Nucleo de Oncologia da Bahia
Verified postcode
Salvador, Brazil

Common questions

What type of cancer is this study for?

This study is for people with a type of lung cancer called non-small cell lung cancer that has spread and can't be removed by surgery.

What medicines are being tested?

The study is testing two medicines together: amivantamab and capmatinib.

Why are they combining two medicines?

Doctors hope that combining these two medicines will be more effective at treating certain types of lung cancer than using them alone.

What are the main goals of the study?

The study aims to find the best dose of these two medicines together and see how well they shrink tumours in patients with specific genetic changes in their cancer.

How long does participation in the study last?

Your participation will continue as long as the treatment is helping you and is safe, with regular hospital visits and check-ups.