A Phase III, double-blind, randomized, placebo-controlled multi-centre, study to assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy (ADAURA)
This study tests a targeted cancer medicine called Tagrisso (osimertinib) in adults who have had surgery to completely remove non-small cell lung cancer. It focuses specifically on people whose tumours have a change in a gene called EGFR. Even after successful surgery, there is a risk that cancer cells might return. In this trial, researchers want to find out whether taking Tagrisso daily for up to three years can keep people cancer-free for longer compared to a dummy pill (placebo). Some people in the trial may have also received chemotherapy after their operation. Participants are randomly chosen by computer to receive either Tagrisso or a placebo tablet. Neither the patient nor their doctor will know which treatment is being given. The study also tracks overall quality of life, general health, and any side effects throughout treatment.
At a glance
What is this study about?
When non-small cell lung cancer is found in its earlier stages, surgery is often the main treatment used to remove the tumour completely. While surgery can be very successful, tiny cancer cells that cannot be seen on scans may sometimes remain in the body. Over time, these cells can cause the cancer to return. For certain people, their cancer cells carry a specific genetic change known as an EGFR mutation, which acts like an 'on switch' telling the cells to grow.
This clinical trial, named ADAURA, is testing a targeted medicine called Tagrisso (osimertinib). Tagrisso is designed to attach to the faulty EGFR switch and turn it off, which may stop any leftover cancer cells from growing. The main purpose of the study is to see if taking Tagrisso every day after surgery helps people stay free of cancer for longer than taking a dummy pill, known as a placebo.
The trial is 'double-blind' and 'placebo-controlled'. This means half of the participants receive Tagrisso and half receive an identical-looking placebo pill, and neither the patients nor their doctors will know who is taking which. Comparing Tagrisso to a placebo helps researchers know for sure whether any improvements or side effects are truly caused by the medicine.
Taking part in research like this helps doctors learn whether giving targeted treatment straight after surgery improves long-term survival and protects quality of life, which could help shape standard NHS cancer care in the future.
Key takeaways
- Tests a daily tablet called Tagrisso against a dummy tablet (placebo) after lung cancer surgery.
- Aimed at adults with stage IB to IIIA non-small cell lung cancer that has an EGFR gene mutation.
- Designed to see if the medicine keeps patients cancer-free for longer.
- Treatment lasts for up to three years with regular hospital check-ups and scans.
- Participation is voluntary and you can leave the study at any time without losing standard care.
Who may be eligible?
This trial is for adults aged 18 and over who have been diagnosed with stage IB, II, or IIIA non-small cell lung cancer. To be considered, you must have already had an operation that completely removed the tumour, and you must have recovered well from your surgery.
Your tumour must also have been tested in a laboratory and confirmed to have an EGFR gene mutation. If your doctor recommended chemotherapy after your surgery, you may still be able to join once that chemotherapy treatment has finished.
You might not be able to join if your cancer has spread to distant parts of the body, if you have certain other heart or lung problems, or if you are unable to swallow tablets. Your study doctor will carry out a range of routine health checks to ensure taking part is safe 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.
- I am aged 18 or older.
- I have had surgery to completely remove non-small cell lung cancer (stage IB to IIIA).
- My cancer tissue has tested positive for an EGFR mutation.
- I have recovered from surgery (and from any chemotherapy given after surgery).
- I am able to attend regular hospital appointments and take daily tablets.
What does participation involve?
Taking part in this study involves taking one tablet once a day with water for up to three years, or until your doctor advises you to stop. You will be randomly assigned to take either Tagrisso (at an 80 mg or 40 mg dose) or a matching placebo tablet.
You will have regular hospital visits, especially in the first few months. At these appointments, the study team will carry out physical examinations, check your blood pressure and weight, and take blood and urine samples. You will also have periodic heart checks (such as an ECG trace and heart scans), eye examinations, and regular chest scans to check that you remain cancer-free.
You will also be asked to complete brief questionnaires about how you are feeling day-to-day. Once you finish taking the study tablets, the team will continue to check on your health over several years to monitor your long-term wellbeing.
Potential risks and benefits
Locations (7)
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedSweden
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedFrance
Common questions
What is an EGFR mutation?
An EGFR mutation is a change in a specific protein on the surface of cells that can cause them to grow and divide too quickly. It is found in some people with lung cancer and means the cancer may respond well to targeted medicines.
What is a placebo and why is it used?
A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. It is used so doctors can clearly see if the new medicine works better than standard care alone without being biased by expectations.
Can I choose whether I receive Tagrisso or the placebo?
No. A computer randomly decides which treatment you receive, like flipping a coin. Neither you nor your doctor can choose or know which tablet you are taking while the trial is running.
What happens if my cancer comes back while on the study?
Your health is monitored closely with regular scans. If your cancer does show signs of returning, the study treatment will stop, and your doctor will discuss standard NHS treatment options with you immediately.
Do I have to pay to take part in this trial?
No. Clinical trial treatments and the extra tests involved are provided free of charge, and you may be able to get help with travel costs to hospital visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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