I4T-MC-JVCY: A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination with Ramucirumab or Placebo in Previously Untreated Patients with EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer
This research is a phase 3 clinical trial for people with advanced non-small cell lung cancer that has a specific genetic change, known as an EGFR mutation. In this study, doctors are investigating two treatment approaches. One group of patients will receive a drug called erlotinib along with another drug called ramucirumab. The other group will receive erlotinib with a placebo (a dummy drug). Doctors want to find out if the combination of erlotinib and ramucirumab is more effective at stopping the cancer from growing or spreading for longer, and if it's safe. This trial aims to compare these two options to see which might be better for patients.
At a glance
What is this study about?
This study, called I4T-MC-JVCY, is a very important type of research known as a Phase 3 clinical trial. It's designed for people who have advanced non-small cell lung cancer that has a particular genetic difference, called an EGFR mutation, and who haven't started treatment for it yet. Researchers are trying to discover if a new combination of medicines could be more helpful than the standard approach.
The main goal is to compare two treatment plans. One plan involves taking a medication called erlotinib along with another drug called ramucirumab. The other plan involves taking erlotinib along with a placebo, which looks like ramucirumab but contains no active medicine. The study is "double-blind," meaning neither the patients nor their doctors will know which treatment plan they are on. This helps make sure the results are as fair and accurate as possible.
The researchers are particularly interested in seeing how long people can live without their cancer growing or spreading further, which is called "progression-free survival." They will also be carefully monitoring any side effects to understand how safe each treatment plan is. This study could help doctors understand better ways to treat this specific type of lung cancer in the future.
Key takeaways
- This study compares two treatments for advanced non-small cell lung cancer with an EGFR mutation.
- One group gets erlotinib plus ramucirumab; the other gets erlotinib plus a dummy drug (placebo).
- It's a 'double-blind' study, meaning you and your doctor won't know which treatment you're on.
- The main goal is to see which treatment keeps the cancer from growing for longer.
- The study also carefully checks for any side effects.
- Participation involves regular clinic visits for blood tests and scans.
Who may be eligible?
To be able to join this study, there are a few important things the researchers need to check. Firstly, you must be 18 years old or older – there's no upper age limit. Both men and women can take part.
Crucially, you would need to have non-small cell lung cancer that has spread to other parts of your body (doctors call this metastatic). Also, your cancer needs to have a specific genetic change known as an EGFR mutation. This is usually found through tests on your cancer tissue.
Finally, you must not have received any previous treatment specifically for your advanced lung cancer. The research team will review your medical history and conduct tests to confirm if you meet all of these criteria.
- Are you 18 years old or older?
- Have you been diagnosed with advanced non-small cell lung cancer?
- Does your cancer have an EGFR gene mutation?
- Have you NOT received any prior treatment for your advanced lung cancer?
- Are you able to attend regular clinic appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be assigned to one of two treatment groups by chance, like flipping a coin. You won't know which group you are in, nor will your doctor, which helps keep the study fair. One group will receive erlotinib plus ramucirumab, and the other will receive erlotinib plus a dummy drug (placebo).
Your involvement will include regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how your cancer is responding. These assessments will happen throughout your treatment. The treatment period could last up to 37 months, or until your cancer shows signs of growing, or if you need to stop treatment for any other reason. Afterwards, you will have follow-up visits or calls to keep track of your health for up to a total of three years from when you started the study. The exact frequency of visits and tests will be explained to you by the study team.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What does 'EGFR mutation-positive' mean?
This means your lung cancer cells have a specific genetic change (a mutation) in a gene called EGFR. This mutation can make the cancer respond to certain targeted treatments.
What is a 'placebo'?
A placebo is a substance that looks exactly like the study drug but doesn't contain any active medicine. It's used to compare the effects of the actual drug more accurately.
What is a 'double-blind' study?
In a double-blind study, neither you nor your doctor will know which treatment you are receiving (the active drug or the placebo). This helps to prevent any bias in the results.
What are the main things the researchers are looking for?
They mainly want to see if the combination treatment can keep your cancer from growing or spreading for longer (progression-free survival), and they will also monitor for any side effects and safety.
How long will I be in the study?
Your treatment period could last up to 37 months, and you'll be followed up for your health for up to three years in total after starting the study, or until your cancer grows.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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