Active not recruitingPHASE3INTERVENTIONAL

A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

This research study is for people with a specific type of lung cancer called non-small cell lung cancer, which can be removed by surgery. We are comparing different treatments given before the operation. One group will receive a drug called osimertinib on its own. Another group will get osimertinib combined with standard chemotherapy. A third group will receive only the standard chemotherapy. We want to find out which approach works best to shrink the cancer and improve surgical outcomes for patients whose cancer has a particular genetic change (EGFRm positive). The study is in its advanced stages (Phase 3), meaning these treatments have been tested before and shown some promise.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

358

Start

16 Dec 2020

Estimated completion

13 Jun 2029

Non-Small Cell Lung Cancer

What is this study about?

This study is about finding better ways to treat a kind of lung cancer known as non-small cell lung cancer. This specific type of cancer has a genetic change called an 'EGFR mutation,' which can make it more sensitive to certain treatments. We are focusing on patients whose cancer can be surgically removed. The main idea is to give treatment before surgery, which doctors call 'neoadjuvant therapy.' This is done to try and shrink the tumour, making the surgery easier and hopefully more successful.

We are comparing three different approaches. One group of patients will receive a newer drug called osimertinib by itself. Another group will get osimertinib along with the standard chemotherapy. The third group will receive only the standard chemotherapy that is typically used. By comparing these groups, we hope to learn if osimertinib, either alone or with chemotherapy, is more effective than chemotherapy alone in preparing patients for surgery and improving their long-term health.

This is a 'Phase 3' study, which means it's a large, important trial. The treatments being tested have already undergone earlier stages of research and shown potential. The results from this study could help doctors decide the best way to treat patients with this specific type of lung cancer in the future, ultimately aiming to improve patient outcomes.

Key takeaways

Tests new treatments (osimertinib and chemotherapy) for lung cancer before surgery.
For non-small cell lung cancer with a specific genetic change (EGFRm positive).
Aims to shrink tumours to help with surgery outcomes.
Compares three treatment approaches to find the most effective one.
Involves regular check-ups and monitoring over time.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be at least 18 years old and have a specific type of non-small cell lung cancer that your doctors believe can be fully removed by surgery. Your cancer must also have a particular genetic change, called an EGFR mutation, which doctors can find by testing your tumour. You'll need to be generally well enough to take part, meaning you can carry out most everyday activities without much trouble.

There are also some reasons why you might not be able to join. For example, if you have certain other serious lung conditions, like a history of lung scarring (interstitial lung disease) or a different type of cancer that is active. You also can't have had radiation therapy to your chest before surgery as part of your treatment plan, or have a less common mixed type of lung cancer.

Your doctors will carefully check all your medical information and test results to see if this study is suitable for you. They will ensure that your cancer is in a stage that qualifies and that you don't have any health issues that would make taking part unsafe.

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 non-small cell lung cancer that can be removed by surgery?
Has your cancer been tested and found to have an EGFR mutation?
Are you generally well and able to carry out most daily activities?
Do you have any serious lung conditions or other active cancers?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of three treatment groups by chance, like flipping a coin. You might receive the new drug osimertinib on its own, osimertinib with standard chemotherapy, or standard chemotherapy alone. You'll take your assigned treatment for a set period before your surgery. During this time, you will have regular visits to the hospital for check-ups, blood tests, and scans to see how you are responding to the treatment.

After your surgery, doctors will continue to monitor your health and recovery. You will have follow-up appointments over several years, even after your treatment before surgery and the operation are complete. This helps researchers understand the long-term effects of the treatments. The exact number of visits and the total length of your participation will be explained in detail by the study team, but it will involve regular clinical assessments over an extended period.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new treatment that could be more effective at shrinking your tumour before surgery. However, like all medical treatments, there are potential risks and side effects associated with osimertinib and chemotherapy, which the study team will explain fully. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (158)

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

Research Site
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Duarte, United States
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Irvine, United States
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San Francisco, United States
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Santa Monica, United States
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Santa Rosa, United States
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Boston, United States
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Lebanon, United States
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Commack, United States
Research Site
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New York, United States
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Houston, United States
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Fairfax, United States
Research Site
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Seattle, United States

Common questions

What is EGFRm positive lung cancer?

It's a type of non-small cell lung cancer where the cells have a specific genetic change (mutation) that can make them respond to targeted drugs like osimertinib.

What does 'neoadjuvant therapy' mean?

It means the treatment (like drugs or chemotherapy) is given before surgery to try and shrink the cancer and make the operation more successful.

Will I know which treatment group I'm in?

Yes, you and your doctors will know which treatment you are receiving (osimertinib alone, osimertinib plus chemotherapy, or chemotherapy alone).

What happens after the treatment before surgery?

After your pre-surgery treatment, you will have surgery to remove your lung cancer, and then continue with follow-up appointments to monitor your health.

Can I stop participating if I change my mind?

Yes, you can choose to leave the study at any point, and it will not affect your ongoing medical care.