Active not recruitingPHASE3INTERVENTIONAL

A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

This global study is for people who have been diagnosed with a specific kind of early-stage lung cancer, called non-small cell lung cancer, which has a particular genetic change (EGFR mutation). All participants will have had surgery to remove their tumour. The study aims to find out if a medicine called osimertinib can help stop the cancer from returning after surgery. Some people will receive osimertinib, while others will get a placebo (a dummy pill with no active drug) to allow for a fair comparison. This is a common way to test new treatments, and it helps doctors understand how well new medicines work and if they are safe.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

390

Start

21 Feb 2022

Estimated completion

01 Nov 2032

Non-Small Cell Lung Cancer

What is this study about?

This research study is about a type of lung cancer called non-small cell lung cancer (NSCLC). Specifically, it's for people whose cancer has a particular genetic fault, known as an EGFR mutation (Ex19del or L858R). These mutations can make cancer cells grow differently. The study focuses on people who have early-stage cancer (Stage IA2 or IA3) and have already had surgery to completely remove their tumour.

The main goal of this study is to see if a drug called osimertinib can help prevent the cancer from coming back after surgery. Sometimes, even after a tumour is removed, some cancer cells can remain and lead to the cancer returning. Osimertinib is a targeted therapy designed to block signals that help cancer cells grow, especially those with the EGFR mutation. By comparing it to a placebo (a dummy pill), researchers can learn if osimertinib makes a real difference in preventing recurrence.

This study is important because it could offer a new way to help people with this specific type of lung cancer stay cancer-free for longer after their initial treatment. Finding more effective ways to prevent cancer recurrence is a key part of improving long-term outcomes for patients.

Key takeaways

This study is for early-stage non-small cell lung cancer with specific genetic changes.
It aims to see if a drug called osimertinib can prevent cancer from returning after surgery.
Participants will receive either the active drug or a dummy pill (placebo) for up to three years.
Regular checks and tests are needed to monitor your health.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you would generally need to be at least 18 years old and have a specific type of non-small cell lung cancer that's not squamous cell cancer. Your cancer must have been diagnosed as stage IA2 or IA3, and you must have had surgery to completely remove the tumour. Importantly, your cancer cells must show a particular genetic change called an EGFR mutation (specifically, Ex19del or L858R).

You also need to be well enough to take part, meaning you've fully recovered from your surgery and can carry out most normal daily activities without much trouble. There are some time limits too: your study treatment can't start within four weeks of surgery, but also no more than 12 weeks should have passed between your surgery and joining the study. You would also need to have a life expectancy of more than six months.

There are reasons why you might not be able to join. For example, if your surgery didn't completely remove the tumour, or if you had a different type of surgery like a pneumonectomy. Certain other serious or uncontrolled health problems, a history of some other cancers, or heart issues could also mean you're not suitable for this study.

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 at least 18 years old?
Do you have early-stage non-small cell lung cancer that's not squamous?
Has your entire tumour been removed by surgery (not just a small part)?
Does your cancer have one of the two specific EGFR genetic changes (Ex19del or L858R)?
Have you generally recovered well from your surgery?
Are you able to do most of your normal daily activities without much difficulty?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups: one receiving the study drug, osimertinib, and the other receiving a placebo (a dummy pill). You will take either the study drug or the placebo once a day for up to three years, unless you need to stop for medical reasons. Neither you nor your doctor will know which treatment you are receiving until the end of the study, which helps make the results fair and unbiased.

Throughout the study, you will have regular hospital visits for doctor check-ups, blood tests, and scans to monitor your health and see how you are responding to the treatment. You will also need to provide a sample of your tumour for testing before you can join. These visits and tests are important to make sure the treatment is safe and effective for you. The total duration of your active participation, including the treatment period and follow-up, will be several years.

Potential risks and benefits

Taking part in a clinical trial means you might benefit from a new treatment that isn't widely available yet, which could potentially help prevent your cancer from returning. However, there's also a chance you might receive the placebo and not the active drug. As with any medication, osimertinib may have side effects, which the study team will carefully monitor. You will be given detailed information about these possible risks. It's important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (139)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Anchorage, United States
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Los Angeles, United States
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Orange, United States
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Grand Junction, United States
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Newark, United States
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Atlanta, United States
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Chicago, United States
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Frederick, United States
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Morristown, United States
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Flushing, United States
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New York, United States
Research Site
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New York, United States

Common questions

What is an EGFR mutation?

An EGFR mutation is a specific change in the genes of your cancer cells. It's like a faulty switch that can make the cancer grow. Some drugs, like osimertinib, are designed to target these specific faulty switches.

Why is there a placebo group?

A placebo group helps researchers fairly compare the new drug's effects. It allows them to see if any improvements are genuinely due to the study drug or if they might have happened anyway or are due to other factors.

How long will I take the study drug?

You would take the study drug or placebo once a day for up to three years, unless you need to stop sooner for medical reasons or if you and your doctor decide it's best.

Will I know if I'm getting the drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you are receiving osimertinib or the placebo. This helps ensure the study results are as accurate as possible.

Can I leave the study if I change my mind?

Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, without having to explain why. Your decision will not affect your ongoing medical care.