A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19)
This study, called ROSIE, is for patients with a type of lung cancer (non-small cell lung cancer) who have a specific genetic change (EGFR mutation, L858R or Del19) and have had their cancer completely removed by surgery. The main goal is to understand why some of these cancers might come back even after patients receive a targeted drug called osimertinib as part of their treatment. By studying samples from patients, researchers hope to identify clues that predict who might benefit most from treatment and, if the cancer returns, to develop better ways to treat it by understanding how the cancer changes over time. This could lead to more personalised and effective care in the future.
At a glance
What is this study about?
This study, called IFCT-2202 ROSIE, focuses on a type of lung cancer called non-small cell lung cancer (NSCLC). Specifically, it's for patients whose cancer has a particular genetic fault, known as an EGFR mutation (either L858R or Del19). These mutations make cancer cells grow in a specific way, and they can often be treated effectively with targeted medicines. The study is for patients who have had surgery to completely remove their lung tumour and are then given a drug called osimertinib to try and stop the cancer from coming back.
The main idea behind this research is to get a really good understanding of what's happening at a genetic level in these patients. Researchers will use special tests on tumour samples taken during surgery and follow patients closely over time. They want to find out if there are any specific genetic clues that can predict whether the cancer is likely to return even after taking osimertinib. They also want to understand how the cancer might change if it does come back, to help doctors choose the best next steps for treatment.
In simple terms, this study aims to learn more about how targeted treatments work in people who have had lung cancer surgery and have specific genetic changes. By gathering detailed information right from the start and continuing to monitor patients, the researchers hope to improve our ability to predict treatment success, understand why treatments sometimes stop working, and ultimately develop better, more personalised care for patients in the future.
Key takeaways
- Study for lung cancer patients with specific genetic changes (EGFR mutation).
- Focuses on patients who have had surgery and are taking osimertinib.
- Aims to understand why cancer might return after targeted treatment.
- Involves genetic testing of blood and tumour samples.
- Could help improve future treatments for similar patients.
- You will receive regular follow-up appointments.
Who may be eligible?
This study is for adults aged 18 or older who have non-small cell lung cancer that has a specific genetic change (EGFR mutation, L858R or Del19). You would need to have had surgery to completely remove your lung tumour, and your doctor would need to plan for you to receive a targeted medicine called osimertinib after surgery.
Before you start, doctors will need to review your scans and surgical information carefully. You also need to have some of your tumour tissue from the surgery available for genetic tests. You must also be able to attend regular appointments for monitoring. If you're a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective contraception during and for two months after treatment. Men who could father a child must also use effective contraception during and for four months after treatment.
You would not be able to join if you've had certain cancer treatments before your surgery, or if your cancer wasn't completely removed during surgery. You also can't join if you have another serious medical condition that the study doctors believe would make participating unsafe 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.
- Are you 18 years old or older?
- Do you have non-small cell lung cancer with an EGFR mutation (L858R or Del19)?
- Have you had surgery that completely removed your lung tumour?
- Is your doctor planning for you to take osimertinib after your surgery?
- Are you able to attend regular follow-up appointments?
- If applicable, are you willing to use effective contraception during and after treatment?
What does participation involve?
If you decide to take part in this study, you would first have a thorough check-up, including scans, before your surgery. After your lung cancer has been completely removed by surgery, and if you meet all the study requirements, you would then start taking the medicine osimertinib. You might also receive standard chemotherapy beforehand if your doctor thinks it's needed.
Throughout the study, your doctors will follow you very closely, typically with appointments every 3 to 6 months, as is standard practice. They will collect blood samples (called 'plasma ctDNA') and tissue from your surgery (called 'FFPE blocks') to perform special genetic tests. These tests will help them understand your cancer better and track any changes over time. The study will last for approximately 3 years while you are receiving osimertinib treatment, but you will continue to be followed according to standard recommendations afterwards.
Potential risks and benefits
Locations (36)
- Angers - CHUVerified postcodeAngers, France· Recruiting
- Bayonne - CHVerified postcodeBayonne, France· Recruiting
- Boulogne - Ambroise ParéVerified postcodeBoulogne, France· Recruiting
- Lyon - URCOTVerified postcodeBron, France· Recruiting
- Caen - CHUVerified postcodeCaen, France· Recruiting
- Clermont-Ferrand - CHUVerified postcodeClermont-Ferrand, France· Recruiting
- Colmar - CHVerified postcodeColmar, France· Recruiting
- Créteil - CHIVerified postcodeCréteil, France· Recruiting
- Dijon - CHU BocageVerified postcodeDijon, France· Recruiting
- Grenoble - CHUVerified postcodeGrenoble, France· Recruiting
- La Roche-Sur-Yon - CHVerified postcodeLa Roche-sur-Yon, France· Recruiting
- Le Mans - CHGVerified postcodeLe Mans, France· Recruiting
Common questions
What is an EGFR mutation?
It's a specific change in the genes within your cancer cells that can make them grow quicker. Certain medicines, like osimertinib, are designed to target these specific changes.
What is osimertinib?
Osimertinib is a targeted drug used to treat certain types of lung cancer with EGFR mutations. In this study, it's given after surgery to try and stop the cancer from coming back.
What are 'plasma ctDNA' and 'FFPE blocks'?
Plasma ctDNA refers to small bits of cancer DNA found in your blood. FFPE blocks are preserved tissue samples from your surgery. Researchers use both for genetic testing.
Will this study change my standard treatment?
No, this study is observing how patients do with standard care (osimertinib after surgery) and collecting extra information through genetic tests to learn more about the disease.
Will I get my genetic test results?
The information gathered from the extensive genetic testing is primarily for research purposes to understand the disease better in groups of patients. You should discuss with your doctor whether any individual results would become part of your routine care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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