A phase 2b, open-label, two-cohort study of subcutaneous amivantamab in combination with lazertinib as first-line treatment, or subcutaneous amivantamab in combination with platinum-based chemotherapy as second-line treatment, for common EGFR-mutated locally advanced or metastatic non-small cell lung cancer
This study is for people with a common type of lung cancer called non-small cell lung cancer (NSCLC) that has spread or is advanced. It specifically focuses on cancer with a particular genetic change in the EGFR gene. Researchers want to see if new combinations of drugs, amivantamab and lazertinib, or amivantamab with standard chemotherapy, can be effective. Amivantamab and lazertinib are designed to target cancer cells with this specific EGFR gene change. This is a Phase 2 study, meaning it's exploring how well these treatments work and their safety. Participants will receive treatment and be carefully monitored. The UK will be involved in testing one of these combinations.
At a glance
What is this study about?
This research study is looking for better ways to treat a common type of lung cancer known as non-small cell lung cancer (NSCLC). Sometimes, this cancer has specific changes in a gene called EGFR. These gene changes can make the cancer grow and spread. While there are treatments available, sometimes they don't work for long, or the cancer can come back.
This study is testing two different combinations of medicines. Both combinations include a drug called amivantamab. One combination uses amivantamab with another drug called lazertinib, given as a first treatment option for people who haven't had other cancer treatments yet. The other combination uses amivantamab with standard chemotherapy drugs for people whose cancer has grown after previous treatments. The hope is that these new combinations will be more effective at fighting the cancer cells that have the specific EGFR gene change.
The main goal of this study is to see how well these drug combinations work and to understand their safety. By taking part, you could help doctors learn more about treating this type of lung cancer, which could benefit many other people in the future.
Key takeaways
- Tests new drug combinations for a specific type of advanced lung cancer.
- Focuses on non-small cell lung cancer (NSCLC) with an EGFR gene change.
- Investigates amivantamab with lazertinib as a first-line treatment in the UK.
- This is a Phase 2 study, looking at effectiveness and safety.
- Participation involves regular check-ups and monitoring.
- You won't pay for study drugs or tests, and travel costs may be reimbursed.
Who may be eligible?
To join this study, you must be 18 years or older and have a diagnosis of advanced or widespread non-small cell lung cancer that cannot be cured by surgery. Your cancer must also have a specific genetic change in the EGFR gene (either Exon 19 deletion or Exon 21 L858R substitution).
You must be in reasonably good general health, and your cancer needs to have at least one area that can be measured by scans. If you have brain tumours that are not causing symptoms or have been treated and are stable, you might still be able to join. For people in the UK, this study is only for those who have not had any previous treatment for their advanced or widespread lung cancer.
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.
- Are you 18 years or older?
- Do you have advanced or widespread non-small cell lung cancer that can't be cured by surgery?
- Does your cancer have an EGFR gene change (Ex19del or Ex21 L858R)?
- Have you NOT had any previous treatment for your advanced or widespread lung cancer (for UK participants)?
- Are you generally in good health with a good ability to perform daily activities?
What does participation involve?
If you join this study, your journey will have three main parts. First, there's a "Screening Phase" that can last up to 28 days. During this time, doctors will do checks to make sure the study is right for you. If you qualify and agree, you'll move to the "Treatment Phase".
During the treatment phase, if you live in the UK, you will receive a combination of amivantamab as an injection under your skin and lazertinib as a pill you take by mouth. This treatment continues until your cancer gets worse, or you're no longer able to take the medicine, or decide to stop. Throughout this period, you'll have regular hospital visits for treatments, health checks, and to see how well the drugs are working. After treatment ends, there's a "Follow-up Phase" where doctors will keep in touch to monitor your health either until the study finishes, your condition changes, or you choose to withdraw. The study is expected to run from August 2025 to November 2030, so regular monitoring will be over several years.
Potential risks and benefits
Locations (6)
- The Royal Marsden NHS Foundation TrustCity onlyLondon, United Kingdom
- The Royal Marsden Hospital (sutton)City onlySutton, United Kingdom
- Guys and St Thomas' NHS Foundation TrustCity onlyLondon, United Kingdom
- The ChristieApproximateManchester, United Kingdom
- The Clatterbridge Cancer Centre NHS Foundation TrustCity onlyWirral, United Kingdom
- Torbay HospitalUnverifiedTorquay, United Kingdom
Common questions
What kind of cancer is this study for?
This study is for a common type of lung cancer called non-small cell lung cancer (NSCLC) that has specific genetic changes in the EGFR gene and has either spread or is locally advanced.
What drugs are being tested?
The study tests combinations of drugs. In the UK, it will be amivantamab (given as an injection under the skin) and lazertinib (taken as a pill).
What does 'Phase 2' mean?
Phase 2 means the study is looking to see how well these new treatments work and if they are safe for patients. It follows earlier studies that checked for basic safety.
Will I have to pay to be in the study?
No, you will not have to pay for the study drugs or tests. The company sponsoring the study will cover these costs and may also help with travel expenses.
How long will the study run?
The study is expected to run from August 2025 to November 2030.
How to find out more
Kanita Theivendran
Always speak to your GP or specialist before deciding to take part in a study.
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