Active not recruitingPHASE3INTERVENTIONAL

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

This research study is about a new medicine called AZD9291 for people diagnosed with a specific type of lung cancer known as non-small cell lung carcinoma. This trial specifically includes patients whose cancer is at an early stage (IB, II, or IIIA) and who have successfully had their tumour completely removed by surgery. Some patients in the study may have also received chemotherapy after their surgery. We are testing to see if AZD9291 is effective and safe in helping to stop the cancer from returning. This medicine targets a specific change in the cancer cells called an EGFR mutation. The study compares AZD9291 to a placebo (a dummy drug) to understand its benefits.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

682

Start

21 Oct 2015

Estimated completion

31 Jan 2029

Stage IB-IIIA Non-small Cell Lung Carcinoma

Results

Results from this study

Posted July 2021

Results have been published for this study.

Primary outcome

Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).

Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).

Full results on the registry

What is this study about?

This study is for people who have been diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC). Specifically, it's for those whose cancer is at an early stage, either IB, II, or IIIA. The most important thing is that your tumour must have been completely removed by surgery. Some people in the study might have also had chemotherapy treatment after their surgery.

The main goal of this study is to see if a new medicine, AZD9291, can help prevent the cancer from coming back after surgery. It's thought that this drug might work particularly well for people whose cancer has a specific genetic change called an EGFR mutation. By comparing AZD9291 to a placebo (a drug with no active ingredients), we can work out if AZD9291 is effective and safe.

This kind of study, where some people get the new drug and others get a placebo without knowing which one they are receiving, helps us get clear and reliable results. Finding new and better ways to treat lung cancer and prevent it from recurring after surgery is very important, and this study aims to contribute to that knowledge.

Key takeaways

This study is for early-stage lung cancer patients (Stages IB-IIIA) after surgery.
It tests a new drug, AZD9291, to see if it stops cancer from returning.
It's only for patients whose cancer has a specific EGFR genetic change.
You'll either receive the drug or a placebo, and neither you nor your doctor will know which.
Participation involves regular hospital visits for monitoring and long-term follow-up.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have been diagnosed with non-small cell lung cancer and have had your tumour completely removed by surgery. We'll need to check your cancer cells for a specific genetic change (an EGFR mutation) to see if you're suitable. You also need to be generally well and recovered from your surgery.

There are some reasons why you might not be able to join. For example, if you've already had radiation or chemotherapy for your lung cancer before or after surgery (apart from standard chemotherapy cycles mentioned above). You also can’t have had any other cancer treatments or major surgery recently. We'll also ask about any other medicines or supplements you're taking to make sure they don't interfere with the study drug.

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?
Have you had lung cancer surgery that completely removed the tumour?
Do you know if your lung cancer has an 'EGFR mutation'?
Are you generally feeling well and recovered from your surgery?
Have you had no prior anti-cancer treatments (except for certain chemotherapy after surgery)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either receive the study drug (AZD9291) or a placebo (a dummy drug). Neither you nor your study doctor will know which one you are getting. You'll take the study drug or placebo daily. You will have regular visits to the hospital for checks, which will include physical examinations, blood tests, and scans to see how you're doing and whether the treatment is working. The study will involve long-term follow-up to monitor your health. The total duration of your participation will depend on how you respond to the treatment and the study plan, potentially lasting for several years.

Potential risks and benefits

Taking part in a clinical trial might mean you get access to a new treatment before it's widely available, which could potentially help prevent your cancer from returning. However, there's no guarantee the treatment will work for you, and like all medicines, AZD9291 can cause side effects. These could be mild or more serious, and the study team will explain all known possibilities. You also might receive a placebo and not the active drug. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (238)

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Los Angeles, United States
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Santa Monica, United States
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Santa Rosa, United States
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Torrance, United States
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Grand Junction, United States
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New Haven, United States
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Norwalk, United States
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Fort Myers, United States
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Pembroke Pines, United States
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St. Petersburg, United States
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Athens, United States
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Honolulu, United States

Common questions

What is an EGFR mutation?

An EGFR mutation is a specific change in the genes of your cancer cells that can make them grow. Some drugs, like the one in this study, are designed to target these specific changes.

What does 'Stage IB-IIIA' mean?

This describes how much your cancer has grown and spread. Stages IB, II, or IIIA mean the cancer is at an early to intermediate stage and is often treatable with surgery.

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

No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're getting AZD9291 or the placebo. This helps make the study results fair and accurate.

What if my cancer comes back during the study?

The study team will monitor you closely. If your cancer comes back, your doctors will discuss the best next steps for your care, which may include leaving the study.

How long will I be in the study?

The study involves long-term follow-up. The exact length will depend on how you respond to treatment and your health, potentially lasting for several years.