RecruitingPHASE2INTERVENTIONAL

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study is for people with a common type of advanced lung cancer called non-small cell lung cancer (NSCLC) that has a specific genetic change, known as an EGFR mutation. Researchers want to find out how well new drug combinations work for these patients. One group will receive amivantamab with lazertinib, and another group will receive amivantamab with platinum-based chemotherapy. Both amivantamab and lazertinib are targeted therapies, meaning they aim to specifically attack cancer cells with these particular genetic changes. The main goal is to see if these treatments can shrink the cancer or stop it from growing, and how safe they are for patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

480

Start

16 Dec 2024

Estimated completion

26 Dec 2030

Carcinoma, Non-Small-Cell Lung

What is this study about?

This research study is looking for better ways to treat a specific type of advanced lung cancer. This cancer is called non-small cell lung cancer (NSCLC), and it has a particular genetic changes called an EGFR mutation (specifically Ex19del or L858R). These changes can make the cancer grow and spread.

Doctors are testing two different approaches in this study. One approach combines a new drug called amivantamab with another drug called lazertinib. Both of these drugs are considered targeted therapies, which means they are designed to attack cancer cells that have these specific EGFR changes, hopefully leaving healthy cells alone. The other approach combines amivantamab with standard chemotherapy, which is a common cancer treatment.

The main aim of this study is to see how well these new drug combinations work in shrinking the cancer or stopping it from growing. Researchers will also be carefully checking for any side effects. This research is important because it could lead to new and more effective treatments for people living with this type of lung cancer.

Key takeaways

This study is for advanced non-small cell lung cancer with a specific genetic change (EGFR mutation).
It tests new drug combinations: amivantamab plus lazertinib, or amivantamab plus chemotherapy.
The goal is to see how well these treatments shrink cancer and their side effects.
You'll have regular hospital visits, tests, and scans if you join.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

To join this study, you must have advanced non-small cell lung cancer that has spread or cannot be cured with surgery. Your cancer must also have a specific genetic change (an EGFR mutation, either Ex19del or L858R) that has been found by a special test.

You also need to be generally well enough to take part, meaning you can mostly look after yourself. Any side effects from previous cancer treatments should have mostly cleared up, with only minor issues remaining. The doctors will also need to be able to measure at least one of your cancer spots on scans.

There are some reasons why you might not be able to join. For example, if you have certain lung conditions like scarring or inflammation (interstitial lung disease or radiation pneumonitis), or if you've had major surgery recently or have one planned. The study doctors will carefully review your medical history to make sure it's safe for you to participate.

Quick self-check

Do you have advanced non-small cell lung cancer that cannot be cured by surgery?
Has your cancer been tested and found to have an EGFR mutation (specifically Ex19del or L858R)?
Are you generally well enough to manage your daily activities?
Do you have any visible cancer spots that doctors can measure on a scan?
Do you have any serious lung scarring or inflammation?
Have you had major surgery or a serious injury in the last 4 weeks?

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

What does participation involve?

Taking part in this study means you would receive one of the experimental treatments mentioned (either amivantamab plus lazertinib, or amivantamab plus chemotherapy). You would have regular appointments to see the study doctors and nurses. During these visits, you'll have physical exams, blood tests, and scans (like CT scans) to see how the treatment is working and check for any side effects. You'll also be asked about how you are feeling and any symptoms you might have. The exact number of visits and tests will depend on the phase of the study and how long you are on treatment. You will continue treatment and follow-up as long as the treatment is helping and you are tolerating it well. The total duration of your participation could vary greatly depending on your individual response to the treatment.

Potential risks and benefits

Participating in this study might offer a chance to try new treatments that are not yet widely available, and these treatments could potentially help control your cancer. However, like all medications, the study drugs can have side effects, which could range from mild to serious. The study team will monitor you closely for any side effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (200)

Southern Cancer Center, PC
Daphne, United States· Recruiting
Clearview Cancer Institute
Huntsville, United States· Recruiting
City of Hope Phoenix
Goodyear, United States· Recruiting
The Oncology Institute of Hope and Innovation
Cerritos, United States· Recruiting
City of Hope Corona
Corona, United States· Recruiting
City of Hope
Duarte, United States· Recruiting
Providence Medical Foundation
Fullerton, United States· Recruiting
Oncology Physicians Network Healthcare
Glendale, United States· Completed
Los Angeles Cancer Network
Glendale, United States· Recruiting
Glendale Adventist Medical Center
Glendale, United States· Recruiting
Marin Cancer Center
Greenbrae, United States· Recruiting
City of Hope Seacliff
Huntington Beach, United States· Recruiting

+188 more sites — see the official record for the full list.

Common questions

What type of lung cancer is this study for?

This study is for a common type of advanced lung cancer called non-small cell lung cancer (NSCLC) that has a specific genetic change (EGFR mutation).

What drugs are being tested?

The study is testing combinations: either amivantamab with lazertinib, or amivantamab with standard chemotherapy.

What is an EGFR mutation?

It's a specific genetic change in your cancer cells (either Ex19del or L858R) that doctors can look for with a test. It helps them understand how your cancer might respond to certain treatments.

Will I know which treatment I'm getting?

The study design will determine if you know or if it's assigned by chance, but the doctors will explain this clearly before you join.

How long will I be in the study?

Your time in the study could vary. You'll continue treatment and follow-up as long as the treatment is helping and you are tolerating it well.

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.