Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI
This study, called AMAZE-lung, is for people with a type of advanced lung cancer called non-small cell lung cancer. Specifically, it's for those whose cancer has a certain genetic change (EGFR mutation) and has continued to grow despite treatment with a specific kind of drug (a third-generation EGFR-TKI like osimertinib or lazertinib). The researchers are testing a new combination of three medications: Amivantamab, Lazertinib, and Bevacizumab (also known as Zirabev®). They want to find out how effective this combination is at treating the cancer and how safe it is for patients. The results from this study will help them plan a larger future study to confirm these findings.
At a glance
What is this study about?
You might be reading this because you or someone you know has been diagnosed with non-small cell lung cancer (NSCLC) and your doctors are considering new treatment options. This study focuses on a specific type of NSCLC where the cancer cells have a particular genetic fault called an EGFR mutation. This fault can make the cancer grow and spread. People in this study have already tried a common medication for this type of cancer, an EGFR-TKI (like osimertinib or lazertinib), but unfortunately, their cancer has started to grow again.
The main goal of this study is to explore a new treatment approach. Researchers are combining three different drugs – Amivantamab, Lazertinib, and Bevacizumab (Zirabev®) – to see if they can work together more effectively. Amivantamab and Lazertinib are designed to target cancer cells with the EGFR mutation in different ways, while Bevacizumab aims to stop the cancer from forming new blood vessels it needs to grow. By combining these, doctors hope to achieve better results for patients.
This is a 'Phase II' study, which means it’s still in the earlier stages of drug development. We know these drugs individually have shown promise, but this study specifically looks at how well they work when given together in a new combination and if the combination is safe. The information gathered from this study will be crucial in helping doctors decide if this combination should be tested in a larger 'Phase III' study, which would then compare it directly to existing standard treatments.
Key takeaways
- This study tests a new three-drug combination for advanced lung cancer with a specific genetic change.
- It's for patients whose cancer has grown even after previous targeted treatment.
- The goal is to see if the new combination is effective and safe.
- It's a Phase II study, gathering information for potential future, larger studies.
- Participation involves regular hospital visits for treatment and monitoring.
Who may be eligible?
To join this study, you need to have a specific type of advanced non-small cell lung cancer that has a certain genetic change called an EGFR mutation (specifically exon 19 deletion or L858R). Crucially, your cancer must have started growing again after you've already received treatment with a third-generation EGFR-TKI drug like osimertinib or lazertinib, and this previous treatment must have worked for at least 6 months.
You also need to be at least 18 years old and generally well enough to take part, meaning you can mostly look after yourself. Your body's organs, like your blood, kidneys, and liver, need to be working well enough. Doctors will also need to be able to measure your cancer to see if the treatment is working.
There are also some reasons why you might not be able to join. For example, if you have a different type of lung cancer called small cell lung cancer, or if you have certain other medical conditions or are taking particular medications. The study team will review all your medical information carefully to see if this study is suitable for you.
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?
- Has your cancer been tested and confirmed to have an EGFR mutation (exon 19 deletion or L858R)?
- Has your cancer started to grow again after treatment with osimertinib or lazertinib, and did that treatment work for at least 6 months initially?
- Are you at least 18 years old?
- Are you generally well enough to go about your daily life, with good organ function (blood, kidney, liver)?
- Can your cancer be measured on scans?
What does participation involve?
If you decide to take part in this study, you would receive the three study drugs – Amivantamab, Lazertinib, and Bevacizumab (Zirabev®) – as a combination treatment. This treatment would be given in cycles that repeat every three weeks. The doctors and nurses will closely monitor your health throughout the study.
You will have regular hospital visits for assessments, which will include blood tests, physical examinations, and scans (like X-rays or CT scans) to see how the cancer is responding and to check for any side effects. The exact number of visits and the total duration of your participation will depend on how you respond to the treatment and your overall health, but the study team will explain all the details to you.
During your time on the trial, you'll need to follow specific instructions about taking your medication and report any new symptoms or issues immediately. After your treatment period, there will be follow-up appointments to track your long-term health. You are always free to withdraw from the study at any time, for any reason, without it affecting your future medical care.
Potential risks and benefits
Locations (18)
- Chu AngersVerified postcodeAngers, France
- Centre Hospitalier d'AvignonVerified postcodeAvignon, France
- Centre Léon BérardVerified postcodeLyon, France
- AO SM Misericorida PerugiaVerified postcodePerugia, Italy
- Netherlands Cancer Institute (NKI)Verified postcodeAmsterdam, Netherlands
- Hospital Universitario de A CoruñaVerified postcodeA Coruña, Spain
- Hospital Universitario Alicante Dr Balmis ISABIALVerified postcodeAlicante, Spain
- ICO BadalonaVerified postcodeBadalona, Spain
- Vall d´Hebron University Hospital VHIOVerified postcodeBarcelona, Spain
- Hospital Universitario BasurtoVerified postcodeBilbao, Spain
- Catalan Institute of OncologyVerified postcodeL'Hospitalet de Llobregat, Spain
- Hospital Universitario Fundación Jiménez DíazVerified postcodeMadrid, Spain
Common questions
What is an EGFR mutation?
An EGFR mutation is a specific change in the genes of lung cancer cells that can make them grow. This study is for people whose cancer has a particular type of EGFR mutation.
What is a 'third-generation EGFR-TKI'?
This is a type of targeted drug treatment, like osimertinib or lazertinib, that is designed to block the signals from the mutated EGFR gene, helping to control the cancer.
What do 'advanced' and 'progression' mean for my cancer?
Advanced means the cancer has spread beyond its original location. Progression means that the cancer has started to grow or spread further despite previous treatment.
What are Amivantamab, Lazertinib, and Bevacizumab?
These are the three different medicines being tested together in this study. They each work in different ways to fight cancer, and the study is seeing if combining them is more effective.
Will my regular doctors still be involved?
Yes, your regular doctors will be kept informed about your participation in the study and will continue to be involved in your overall care.
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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