RecruitingOBSERVATIONAL

A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting

This study is gathering information about people in the UK who have a type of lung cancer called non-small cell lung cancer (NSCLC), which has spread to other parts of the body (metastatic). Specifically, it's focusing on those whose cancer has a particular genetic difference called an 'EGFR mutation'. The study aims to understand how well a treatment called amivantamab works in real-life situations for these patients and how it affects their health and daily lives. It's not a study where new treatments are tested, but rather it observes how existing amivantamab-containing treatments are used and what their outcomes are in everyday medical practice.

At a glance

Status

Recruiting

Sponsor

Janssen Research & Development, LLC

Enrolment target

380

Start

03 Dec 2025

Estimated completion

17 Dec 2030

Carcinoma, Non-Small-Cell Lung

What is this study about?

This study is looking at a type of lung cancer called non-small cell lung cancer, often shortened to NSCLC. It's the most common kind of lung cancer. Sometimes, this cancer can spread to other parts of the body, which doctors call 'metastatic'. A key feature for this study is that the cancer has a specific change, or 'mutation', in a gene called EGFR. This EGFR mutation helps doctors choose certain treatments because it means the cancer might respond to them.

The main goal of this study is to see how well a treatment called amivantamab works for people in the UK with this specific type of NSCLC. It's not a trial where people are given a new or experimental drug. Instead, it's observing people who are already going to be treated with amivantamab as part of their regular care. The study wants to understand their health and how they are doing over time.

By collecting information from many patients, researchers hope to get a clearer picture of how amivantamab-containing treatments work in the real world. This information can help doctors and patients make better decisions about treatment in the future. It's about learning from current experiences to improve care for others with advanced EGFR-mutated NSCLC.

Key takeaways

This study is for adults with a common type of lung cancer (NSCLC) that has spread.
It only includes people whose cancer has a specific genetic change called 'EGFR mutation'.
The study watches how an approved treatment called amivantamab works in real life.
It aims to understand patients' health and outcomes while on this treatment.
Participation means allowing your medical information to be used for research without affecting your care.

Who may be eligible?

To be part of this study, you would need to have been diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC) that has specific genetic changes (EGFR mutations, like exon 19 deletions or L858R substitution in exon 21). Your doctor must have already decided that treatment with amivantamab is suitable for you, following the approved guidelines for this medication. You also need to agree to participate and allow researchers to review your medical information.

You would not be able to join if you are already receiving other active cancer treatments for your advanced NSCLC that are not part of an approved combination with amivantamab. You also can't have received amivantamab before, either in a clinical trial or through compassionate use. If you have medical conditions that are listed as reasons not to take amivantamab in the official drug information, or if you are being treated with a similar but not original version of the drug, you would also not be eligible.

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 a confirmed diagnosis of non-small cell lung cancer (NSCLC)?
Does your cancer have specific EGFR mutations (like exon 19 deletions or L858R substitution)?
Has your doctor already decided that amivantamab treatment is right for you, matching approved guidelines?
Are you about to start amivantamab treatment for the first time within the next 4 weeks?
Have you not received amivantamab before, either in a trial or for compassionate use?

Answer every question to see your result.

What does participation involve?

This study is not giving you a new or experimental treatment; it's observing people who are already receiving amivantamab as part of their routine care. If you qualify, you would provide your consent to be part of the study. This mainly involves allowing the study team to collect information from your existing medical records regarding your health outcomes and treatment with amivantamab. There are no extra hospital visits or special tests specifically for the study. The information collected will include details about your cancer, the amivantamab treatment you receive, and how your health changes over time while you're on this treatment. The total duration of your participation would depend on how long you receive the treatment and follow-up care as determined by your doctor.

Potential risks and benefits

The main benefit of taking part is that your medical information will contribute to a better understanding of how amivantamab works for people with your type of lung cancer in real-world settings. This can help improve care for future patients. There are no direct medical benefits to you personally from participating in this observational study, as it doesn't change your treatment. As this is not an interventional trial, you won't be exposed to new or unknown risks from the study itself, beyond those associated with your standard amivantamab treatment. However, sharing your medical data always carries a small risk of loss of privacy, though strong measures are in place to protect your information. You are free to withdraw from the study at any time without affecting your medical care.

Locations (60)

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

University Hospital Graz
Verified postcode
Graz, Austria· Recruiting
Klinikum Klagenfurt am Worthersee
Verified postcode
Klagenfurt, Austria· Recruiting
UZ Brussel
Verified postcode
Brussels, Belgium· Recruiting
Az Groeninge
Verified postcode
Kortrijk, Belgium· Recruiting
Vitaz
Verified postcode
Sint-Niklaas, Belgium· Recruiting
Fakultni nemocnice Brno
Verified postcode
Brno, Czechia· Recruiting
Fakultni nemocnice Hradec Kralove
Verified postcode
Hradec Králové, Czechia· Recruiting
Fakultni nemocnice Olomouc
Verified postcode
Olomouc, Czechia· Recruiting
Fakultni Thomayerova nemocnice
Verified postcode
Prague, Czechia· Recruiting
MVZ am Klinikum Aschaffenburg Onkologie
Verified postcode
Aschaffenburg, Germany· Recruiting
Evangelisches Klinikum Bethel
Verified postcode
Bielefeld, Germany· Recruiting
Augusta Kliniken Bochum Hattingen
Verified postcode
Bochum, Germany· Recruiting

Common questions

What is EGFR-mutated NSCLC?

It's a common type of lung cancer with a specific genetic change (mutation) in the EGFR gene, which can help doctors choose certain treatments.

What is amivantamab?

Amivantamab is a medication used to treat this specific type of advanced lung cancer.

Will I get a new drug in this study?

No, you will be receiving amivantamab as part of your standard medical care; the study just observes how it works.

Do I have extra appointments if I join?

No, there are no extra appointments or tests specifically for this study. Information is collected from your existing medical records.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and your medical care will not be affected.

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.