Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)

This study is for people with a type of lung cancer called non-small cell lung cancer (NSCLC) that started to grow again after they had an initial treatment called osimertinib. Doctors want to see if adding osimertinib to chemotherapy works better than adding a dummy pill (placebo) to chemotherapy. Patients will receive either chemotherapy plus osimertinib, or chemotherapy plus the dummy pill. The main goal is to find out if this combination can help control the cancer for longer and if it's safe. It's a Phase 3 study, meaning it's one of the final steps before a new treatment might become widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

Start

12 Sep 2021

Estimated completion

02 Jun 2027

Non-small Cell Lung Cancer

Results

Results from this study

Posted January 2026

Results have been published for this study.

Primary outcome

Progression Free Survival (PFS)

Progression free survival is defined as time from randomization until progression (intracranial or extracranial, whichever occurs first) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (for extracranial progression) and Central nervous system (CNS) RECIST 1.1 (for intracranial progression) as assessed by the Investigator at local site or death due to any cause.

Full results on the registry

What is this study about?

This research study is looking at a new treatment approach for a specific type of lung cancer called non-small cell lung cancer (NSCLC). This type of cancer has certain genetic changes (called EGFR mutations) that make it respond to particular medications. If you've previously been treated with a drug called osimertinib and your cancer has started to grow outside of the brain again, this study might be relevant to you.

The main aim of the study is to compare two treatment plans: one combines standard chemotherapy with osimertinib, and the other combines the same chemotherapy with a 'dummy pill' (placebo). By comparing these two groups, doctors hope to understand if adding osimertinib to chemotherapy is more effective at slowing down or stopping the cancer's growth, and if it's a safe option for patients.

Taking part in a study like this means you would be helping doctors learn more about the best ways to treat lung cancer. This knowledge could help many other patients in the future. The study is carefully designed to get reliable answers while focusing on the safety and well-being of everyone involved.

Key takeaways

This study evaluates chemo plus osimertinib for a type of lung cancer that has progressed.
It's for people whose cancer showed specific genetic changes and grew after initial osimertinib treatment.
Participants will be randomly assigned to receive either active drug or a dummy pill with chemotherapy.
The aim is to see if combining these treatments is more effective and safe.
Regular checks and tests will monitor your health throughout the study.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you would typically need to have non-small cell lung cancer that has a specific genetic change (EGFR mutation). Your cancer should have been treated before with a drug called osimertinib, and it must have recently started to grow again outside of your brain, but you haven't received any other treatments since then. You also need to be reasonably well and able to carry out most daily activities.

There are also some reasons why you might not be able to join. For example, if your cancer has started to grow in your brain after your first osimertinib treatment, or if you have certain other serious medical conditions, especially related to your heart or lungs, you might not be eligible. The study team will check your full medical history to make sure it's safe for you to take part.

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.

Do you have non-small cell lung cancer with an EGFR genetic change?
Has your cancer been treated with osimertinib before, and has it recently started to grow again outside your brain?
Are you generally well and able to manage most daily activities?
Do you have good heart and lung health, without certain serious conditions?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be randomly assigned to one of two groups: one group gets chemotherapy plus osimertinib, and the other gets chemotherapy plus a dummy pill. You wouldn't know which group you are in, and neither would your doctors, to ensure fair results. The chemotherapy involves medicines called pemetrexed and either cisplatin or carboplatin, given through a drip on the first day of a 21-day cycle, for four cycles. During this time, you would also take either osimertinib or the dummy pill daily.

After these first four cycles, if your cancer is stable or has improved, you would continue taking the daily pill (osimertinib or placebo) along with pemetrexed chemotherapy every 21 days as a 'maintenance' treatment. You would have regular hospital visits for blood tests, scans, and check-ups to monitor your health and how the treatment is working. The total time you spend in the study depends on how well the treatment works for you and will be discussed in detail.

Potential risks and benefits

Participating in this study might offer a potential benefit if the combination of chemotherapy and osimertinib works better than chemotherapy alone, possibly helping to control your cancer for longer. However, like all medications, both chemotherapy and osimertinib can cause side effects. These can range from mild, such as tiredness or feeling sick, to more serious issues, which your study doctor will explain fully. There's also the chance you might receive the dummy pill alongside chemotherapy, meaning you wouldn't get the active new treatment. You can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (40)

Research Site
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Silver Spring, United States
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Boston, United States
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Beijing, China
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Beijing, China
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Ganzhou, China
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Guangzhou, China
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Jinan, China
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Shenyang, China
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Tianjin, China
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Zhengzhou, China
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Berlin, Germany
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Cologne, Germany

Common questions

What is non-small cell lung cancer (NSCLC)?

It's the most common type of lung cancer. This study focuses on NSCLC with specific genetic changes called EGFR mutations.

What is osimertinib?

Osimertinib is a targeted cancer drug that works by blocking certain signals that help cancer cells grow, especially in lung cancers with EGFR mutations.

What does 'extracranial disease progression' mean?

This means your cancer has started to grow outside of your brain after your previous treatment.

Will I know if I'm getting the dummy pill?

No, neither you nor your study doctor will know whether you are receiving osimertinib or the dummy pill. This is standard in studies to ensure fair results.

What is 'Phase 3' of a clinical trial?

Phase 3 is an advanced stage of a trial, where new treatments are compared to current standard treatments, often involving a larger number of patients to confirm effectiveness and safety.