A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
This study is looking at people with a type of advanced lung cancer called non-small cell lung cancer, which has specific genetic changes (EGFR mutations). We are comparing two ways to give a medicine called amivantamab. One way is the standard intravenous (into a vein) drip. The other is a new version of amivantamab given as an injection under the skin. The main goal is to see if this new injection is simpler and quicker to give, making it a better experience for patients and medical staff. We want to understand if it works just as well and is safe.
At a glance
What is this study about?
This research study is about a type of advanced lung cancer called non-small cell lung cancer. Specifically, it's for people whose cancer has certain genetic changes, known as EGFR mutations. We're interested in improving how a vital medicine called amivantamab is given.
Currently, amivantamab is usually given to patients through a drip into a vein. This can take a while and sometimes isn't the most convenient for patients or doctors. The aim of this study is to test a new version of the medicine that can be given as an injection just under the skin. This new injection is designed to be much simpler and quicker to administer.
By comparing the injection with the current drip method, we want to find out if the new injection works just as well, is safe, and makes the treatment experience better for patients. We hope it can offer a more comfortable and efficient way for people to receive their treatment.
Key takeaways
- This study compares two ways to give advanced lung cancer medicine: drip vs. injection.
- It's for people with a specific type of EGFR-mutated non-small cell lung cancer.
- The goal is to find a simpler, quicker, and patient-friendly way to give treatment.
- Participation includes regular clinic visits, blood tests, and scans.
- You will receive either the drip or the experimental injection plus lazertinib.
Who may be eligible?
To join this study, you need to have a specific type of advanced non-small cell lung cancer that has certain genetic changes (called EGFR Exon 19 deletion or Exon 21 L858R mutation). Your cancer must have gotten worse after you've already had certain treatments, including osimertinib (or a similar medicine) and platinum-based chemotherapy.
You also need to be generally well enough to take part, meaning you can mostly look after yourself. The medical team will check if there's at least one part of your cancer that can be measured to see how well the treatment is working. Any side effects from previous treatments must have mostly cleared up.
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 advanced non-small cell lung cancer with specific EGFR mutations?
- Has your cancer progressed after treatments like osimertinib and chemotherapy?
- Are you generally well and able to mostly look after yourself (ECOG 0-1)?
- Have your previous treatment side effects mostly cleared up?
- Is there at least one area of your cancer that can be measured by scans?
What does participation involve?
If you join this study, you will either receive the standard amivantamab medicine through a drip into your vein OR the new amivantamab injection under your skin, along with another medicine called lazertinib. You won't get to choose which group you are in; it will be decided randomly.
Throughout the study, you'll have regular hospital visits for your treatment, blood tests, scans (like CT scans) to check your progress, and health checks by doctors and nurses. These appointments will help the research team see how the treatment is working and if you have any side effects. The total length of your participation will depend on how you respond to the treatment and what the study doctors advise.
Potential risks and benefits
Locations (187)
- City of Hope DuarteVerified postcodeDuarte, United States
- City of Hope Orange County Lennar Foundation Cancer CenterVerified postcodeIrvine, United States
- City of Hope Long Beach ElmVerified postcodeLong Beach, United States
- National Jewish HealthVerified postcodeDenver, United States
- Baptist Lynn Cancer InstituteVerified postcodeBoca Raton, United States
- Orlando HealthVerified postcodeOrlando, United States
- University of KansasVerified postcodeKansas City, United States
- University of MichiganVerified postcodeAnn Arbor, United States
- Astera Cancer CareVerified postcodeEast Brunswick, United States
- Rutgers Cancer Institute of New JerseyVerified postcodeNew Brunswick, United States
- NYU Langone Health Laura and Isaac Perlmutter Cancer CenterVerified postcodeNew York, United States
- Montefiore Medical CenterVerified postcodeThe Bronx, United States
Common questions
What is EGFR-mutated lung cancer?
It's a type of lung cancer where the cancer cells have specific changes in a gene called EGFR, which can sometimes make the cancer grow.
What is amivantamab?
It's a medicine used to treat this type of lung cancer, designed to block the signals that make cancer cells grow.
What does 'subcutaneous' mean?
It means the medicine is given as an injection just under your skin, rather than directly into a vein.
What is 'lazertinib'?
Lazertinib is another medicine that researchers are studying alongside amivantamab for this type of lung cancer.
How long will the study last?
The length of your participation will depend on your individual response to the treatment and your doctor's advice.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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