Phase II trial of amivantamab plus monochemotherapy in platinum unfit NSCLC patients with EGFR exon20 insertion mutations
This research study is for people with a kind of lung cancer called non-small cell lung cancer (NSCLC) that has a specific change in its genes (called EGFR exon 20 insertion mutations). These patients often haven't been able to have platinum-based chemotherapy due to health reasons. The study is testing a combination of a new drug, amivantamab, with a standard chemotherapy drug, pemetrexed. It's a 'Phase II' study, which means researchers are checking how effective this new combination is at shrinking the cancer. They will also look at how long the treatment works and its safety. The goal is to find better treatment options for this particular group of patients.
At a glance
What is this study about?
This study is looking into a new treatment for a specific type of lung cancer called non-small cell lung cancer (NSCLC). This type of cancer has a particular genetic change, or 'mutation,' known as an EGFR exon 20 insertion. Sometimes, people with this type of lung cancer can't have certain strong chemotherapy treatments, like those that use platinum-based drugs, because of other health reasons. This trial is exploring a different approach for these individuals.
The main idea behind this study is to see how well a new drug called amivantamab works when given together with a common chemotherapy drug called pemetrexed. Amivantamab is designed to target specific proteins on cancer cells. Researchers want to find out how many people respond to this combined treatment, meaning their cancer either shrinks or stops growing. This is important because it could offer a new option for patients who currently have limited choices.
This is a Phase II study, which means the researchers are focusing on understanding how effective the treatment is and closely monitoring for any side effects. They will be looking at things like how long the treatment works, how long people live after starting the treatment, and the overall safety of the drug combination. The insights gained from studies like this are crucial for developing new medicines and improving care for people with cancer.
Key takeaways
- Tests a new combination treatment for specific lung cancer.
- For NSCLC patients with EGFR exon 20 insertion mutations.
- Designed for those who cannot receive standard platinum chemotherapy.
- Aims to measure how well the treatment shrinks cancer.
- Also looking at safety and how long the treatment works.
- Could offer a new option for this patient group.
Who may be eligible?
To join this study, adult patients must have a specific type of lung cancer called non-small cell lung cancer (NSCLC). They need to have a particular genetic change in their cancer, known as an EGFR exon 20 insertion mutation.
Another important requirement is that patients must not be able to have standard platinum-based chemotherapy treatments, often because of other health conditions. Both men and women can take part in the study, and you need to be at least 18 years old.
The research team will carry out several checks and tests to make sure that the study is right for you and that you meet all the necessary health and cancer requirements. It's important to discuss your full medical history with the study doctor.
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 I have non-small cell lung cancer (NSCLC)?
- Does my cancer have an EGFR exon 20 insertion mutation?
- Am I unable to receive standard platinum-based chemotherapy?
- Am I 18 years old or older?
- Am I prepared for regular hospital visits for treatment and checks?
What does participation involve?
If you decide to take part in this study, you would receive the new drug amivantamab along with the chemotherapy drug pemetrexed. Both of these are given as infusions, meaning they are delivered directly into your bloodstream, usually through a vein in your arm. The frequency and number of these infusions would be set by the study's treatment plan. You would have regular visits to the hospital or clinic to receive your treatment and for health checks.
During these visits, the study team would perform various assessments. These include blood tests, physical examinations, and scans (like CT or MRI scans) to see how the treatment is affecting your cancer and your overall health. They will also ask you questions about how you are feeling and any side effects you might be experiencing. The study will continue for a period, with follow-up appointments to monitor your health even after treatment has stopped. The total duration of your participation, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is non-small cell lung cancer (NSCLC)?
It's the most common type of lung cancer.
What does 'EGFR exon 20 insertion mutations' mean?
It's a specific change in the cancer cells that the treatment aims to target.
What is 'platinum unfit'?
It means a patient can't safely receive standard chemotherapy drugs that contain platinum.
What kind of treatment will I receive?
You'll receive two drugs: amivantamab and pemetrexed, given as infusions.
Will this treatment cure my cancer?
This study aims to see how well the treatment shrinks the cancer and its effects, but it's not guaranteed to be a cure.
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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