RecruitingPHASE2INTERVENTIONAL

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

This research study is investigating a new way to give a treatment called amivantamab to people with a type of lung cancer known as non-small cell lung cancer that has spread. Currently, amivantamab is usually given by a drip into a vein. This study is testing a new version that can be injected under the skin. Researchers want to find out if this new injection method is effective at shrinking tumors and whether it is safe. The study focuses on patients whose lung cancer has specific genetic changes in a protein called EGFR. Some parts of the study will test amivantamab on its own, while others will look at it when given with other treatments like lazertinib, carboplatin, or pemetrexed. It's hoped that an under-the-skin injection might be more convenient for patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

520

Start

11 Nov 2022

Estimated completion

18 Aug 2028

Carcinoma, Non-small-Cell Lung

What is this study about?

This study is designed to explore a new way of giving an important cancer medicine called amivantamab. Amivantamab is used to treat a specific type of lung cancer, known as non-small cell lung cancer, especially when it has spread in the body. Currently, patients receive this medication through a long drip into a vein, which can be time-consuming and often requires hospital visits. This study is testing if amivantamab can be given as a simple injection under the skin instead, using a special combination that helps the body absorb the medicine more easily.

The main goals of this research are to see how effective this new under-the-skin injection is at fighting the cancer, and to make sure it's safe for patients. Different groups of patients will be involved, some receiving amivantamab on its own, and others receiving it alongside other cancer treatments. The study is particularly interested in patients whose lung cancer has specific genetic changes, called EGFR mutations, which amivantamab is designed to target.

Finding a way to give amivantamab as an under-the-skin injection could make treatment much easier and more convenient for patients, potentially reducing the need for lengthy hospital stays for infusions. This could significantly improve their quality of life while undergoing cancer treatment. The researchers will be carefully monitoring all participants to understand the benefits and any side effects of this new treatment method.

Key takeaways

This study is for advanced non-small cell lung cancer with specific genetic changes.
It's testing a new, potentially more convenient, under-the-skin injection of a drug called Amivantamab.
The study aims to check how well the injection works and if it's safe.
Some patients will receive Amivantamab alone; others will get it with additional cancer drugs.
Participation involves regular check-ups, blood tests, and scans.
You can stop participating at any time.

Who may be eligible?

To join this study, you must have an advanced or spreading type of non-small cell lung cancer that doctors can't cure with surgery or radiation. Your cancer must have specific genetic changes called EGFR mutations. Different parts of the study look for slightly different types of these mutations, so your doctor will need to check your specific cancer test results.

Some parts of the study are for people who haven't had any other full-body treatment for their lung cancer yet. Other parts are for those whose cancer has gotten worse after specific previous treatments, such as osimertinib, or a combination of amivantamab and lazertinib. You must be at least 18 years old to take part, and the study is open to both men and women. If you have a type of lung cancer called squamous non-small cell lung cancer, you generally won't be able to join some specific parts of this study.

Crucially, your doctor will need to confirm your cancer's genetic changes using official lab tests. If you are already receiving amivantamab through a drip for at least 8 weeks without dose changes, you might also be eligible for a particular group within this study that is testing the new injection form.

Quick self-check

I have non-small cell lung cancer that has spread.
My cancer has specific EGFR genetic changes (my doctor can confirm this).
I am at least 18 years old.
I might not have had previous treatment, or my cancer progressed after specific treatments.
My doctors say my cancer can't be cured by surgery or chemoradiation.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will receive the study treatment, which is amivantamab given as an injection under the skin. Depending on which group you are in, you might also receive other medications like lazertinib, carboplatin, or pemetrexed, or blood clot prevention medicines.

You will have regular appointments for check-ups, blood tests, and scans to see how the treatment is working and to monitor your health. These visits will help the study doctors understand the effects of the treatment. The total duration of your participation will vary, but you will be monitored closely throughout the treatment period and for some time after your last dose. All procedures and study visits will be carefully explained to you by the study team.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new treatments before they are widely available. For this study, if the under-the-skin injection of amivantamab proves effective and safe, it could offer a more convenient way to receive your cancer treatment. However, as with any medical treatment, there are potential risks and side effects. Amivantamab and the other drugs used can cause various side effects, which will be fully explained 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 (110)

University of California at San Diego
La Jolla, United States· Recruiting
University of California Irvine
Orange, United States· Recruiting
Stanford Cancer Institute
Stanford, United States· Recruiting
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., United States· Recruiting
Baptist Lynn Cancer Institute
Boca Raton, United States· Completed
Mount Sinai Medical Center
Miami Beach, United States· Recruiting
AdventHealth
Orlando, United States· Recruiting
H. Lee Moffitt Cancer & Research Institute
Tampa, United States· Completed
University of Kansas Cancer Center
Westwood, United States· Recruiting
Sidney Kimmel Cancer Center - Bayview Campus
Baltimore, United States· Recruiting
Boston Medical Center
Boston, United States· Recruiting
Washington University School Of Medicine
St Louis, United States· Recruiting

+98 more sites — see the official record for the full list.

Common questions

What is Amivantamab?

Amivantamab is a medicine used to treat a specific type of lung cancer that has certain genetic changes. It helps to block signals that make cancer cells grow.

Why are they testing an injection under the skin?

Currently, Amivantamab is given through a vein. Researchers want to see if giving it as an injection under the skin is just as effective and safe, and potentially more convenient for patients.

What are EGFR mutations?

EGFR (Epidermal Growth Factor Receptor) mutations are specific changes in the genetic code of some cancer cells. These changes can make cancer grow and spread, and some medicines like Amivantamab are designed to target them.

Will I receive other treatments in this study?

Depending on which group you are in, you might receive Amivantamab on its own, or combined with other medications like Lazertinib, Carboplatin, or Pemetrexed. Your doctor will explain your specific treatment plan.

Can I stop participating in the study if I want to?

Yes, you are free to leave the study at any time, for any reason, without it affecting your future medical care.

How to find out more

Study Contact

Participate-In-This-Study1@its.jnj.com 844-434-4210 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.