RecruitingPHASE3INTERVENTIONAL

A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This research study is for people with advanced non-small cell lung cancer that has a specific genetic change (EGFR mutation). It's for patients whose cancer has progressed after being treated with osimertinib. The study aims to find out if new treatments, Dato-DXd given alone or together with osimertinib, are better than standard chemotherapy. 'Better' means keeping the cancer from growing or spreading for longer. Patients will be split into three groups by chance: one group will get Dato-DXd plus osimertinib, another will get Dato-DXd alone, and the third will receive chemotherapy. Doctors will closely monitor how well the treatments work and any side effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

744

Start

04 Oct 2024

Estimated completion

27 Sep 2028

Metastatic Non-small Cell Lung Cancer

What is this study about?

This study is about finding better ways to treat a specific kind of advanced lung cancer called non-small cell lung cancer. This cancer has a particular genetic change, or 'mutation,' known as an EGFR mutation. If you have this type of cancer and it has unfortunately started to grow again after you've been treated with a drug called osimertinib, this study might be relevant to you. We are looking for new treatments because, currently, options are limited once osimertinib stops working.

The main goal of this research is to compare new treatments against the chemotherapy often used in this situation. The new treatments involve a drug called Dato-DXd, which will be given either on its own or in combination with osimertinib. We want to see if these new approaches can help patients live longer without their cancer growing or spreading, which doctors call 'progression-free survival.' By comparing these different treatments, we hope to find out which one is most effective and has tolerable side effects.

Patients taking part in this study will be randomly assigned to one of three treatment groups. This means you won't choose which treatment you get; it's decided by chance, like flipping a coin. One group will receive Dato-DXd plus osimertinib, another will get Dato-DXd alone, and the third group will receive standard chemotherapy (either Pemetrexed combined with Carboplatin or with Cisplatin). This approach helps us fairly compare the effects of each treatment. The study is also looking at how safe these treatments are and how they affect patients' overall health and well-being.

Key takeaways

This study is for advanced lung cancer with a specific EGFR mutation, after previous treatment with osimertinib.
It compares new drug combinations (Dato-DXd with/without osimertinib) against standard chemotherapy.
The main aim is to see if new treatments can stop cancer from growing for longer.
Patients are assigned to treatment groups by chance (randomized).
Regular checks, scans, and blood tests are part of the process.
You can stop participating at any time.

Who may be eligible?

This study is for adults generally aged 18 and over who have non-small cell lung cancer. Specifically, your cancer must have a particular genetic change (an EGFR mutation) and must have unfortunately started to grow again after you've been treated with osimertinib. Your doctors would need to have seen pictures (like scans) showing that your cancer has progressed outside of your brain.

You should also be generally well enough to take part, meaning you can mostly go about your daily activities without too much difficulty. You should not have other serious health problems, such as uncontrolled heart issues, severe lung problems, or an active serious infection. If you've had certain other cancers recently or received chemotherapy for cancer that hasn't spread in the last year, you might not be able to join. Your doctors will check if you meet all the requirements.

Quick self-check

Do you have non-small cell lung cancer?
Has your lung cancer been confirmed to have an EGFR mutation?
Has your cancer started to grow again after you were treated with osimertinib?
Are you generally well enough to manage daily activities?
Are you free from other serious, uncontrolled medical conditions?
Have you not had certain other cancers recently or chemotherapy for non-metastatic cancer in the last year?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you will be assigned by chance to one of three treatment groups. You'll either receive Dato-DXd plus osimertinib, Dato-DXd alone, or standard chemotherapy. You will continue to receive the study treatment for as long as it helps control your cancer, or until any side effects become too difficult, or for other medical reasons decided by your doctor.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to see how well the treatment is working and to monitor for any side effects. These scans will help doctors measure if your cancer is shrinking, staying the same, or growing. After you stop taking the study treatment, you'll have a final visit within about five weeks to check your health. Following this, you'll have another safety check call around a month later to ensure you're recovering well. The total duration of your participation will vary depending on how long you receive treatment and the follow-up period.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is that you might receive a new treatment that could be more effective than standard care in controlling your lung cancer or offer a better quality of life. However, there's no guarantee the treatment will work for you, and it might not be better than existing options. All treatments, including those in this study, can have side effects, which your medical team will discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care, and your doctors will continue to support you.

Locations (303)

Research Site
Fayetteville, United States· Recruiting
Research Site
Duarte, United States· Withdrawn
Research Site
Fountain Valley, United States· Recruiting
Research Site
La Jolla, United States· Recruiting
Research Site
Los Angeles, United States· Withdrawn
Research Site
San Diego, United States· Recruiting
Research Site
Colorado Springs, United States· Recruiting
Research Site
Fort Collins, United States· Recruiting
Research Site
Washington D.C., United States· Not yet recruiting
Research Site
Gainesville, United States· Withdrawn
Research Site
Jacksonville, United States· Recruiting
Research Site
Athens, United States· Recruiting

+291 more sites — see the official record for the full list.

Common questions

What is an EGFR mutation?

EGFR stands for Epidermal Growth Factor Receptor. It's a protein on the surface of cells, and a 'mutation' means there's a change in the gene that makes this protein. In lung cancer, this mutation can make cancer cells grow more quickly.

What does 'progression-free survival' mean?

It's a way doctors measure how well a treatment is working. It refers to the length of time you live with the disease without it getting worse or spreading, based on scans and other tests.

What is 'randomized' treatment?

Being 'randomized' means you are assigned to a treatment group by chance, like rolling a dice. This helps make the study fair and scientific, so we can get reliable results about the treatments.

What if I experience side effects during the study?

Your medical team will closely monitor you for any side effects at every visit. It's very important to tell them about any new symptoms you experience. They will provide care and may adjust your treatment if needed.

Can I leave the study if I change my mind?

Yes, absolutely. Participating in a clinical trial is always voluntary. You can choose to leave the study at any time, for any reason, without it affecting your future medical care.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.