Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to test Aumolertinib in European participants with genetically linked advanced Lung Cancer

This study is looking at a new medicine called Aumolertinib. It's for people in Europe who have a kind of advanced lung cancer known as Non-Small Cell Lung Cancer (NSCLC). This particular cancer has a specific genetic change, which doctors call an EGFR mutation. The main goal of this early-stage study is to understand if Aumolertinib is safe to use and how it acts in the body. If you have been diagnosed with this type of lung cancer and meet certain health criteria, you might be able to consider taking part. This is an important step in finding new ways to treat lung cancer, and studies like this help scientists learn more about new medicines before they can be widely used.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Jiangsu Hansoh Pharmaceutical Group Co. Ltd.

Enrolment target

Start

27 Mar 2025

Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations

What is this study about?

This research study is about a new medicine called Aumolertinib. It's being tested for people who have a type of advanced lung cancer. This particular lung cancer is called Non-Small Cell Lung Cancer, and it has a specific genetic change known as an EGFR mutation. These mutations are like tiny changes in the cancer cells' DNA that can make the cancer grow.

The main aim of this study is to find out more about how Aumolertinib works in the body and if it's safe for people to take. Because it's an early-stage study (Phase I), the focus is on safety and understanding the medicine's effects rather than directly comparing it to other treatments yet. Doctors and scientists hope that new medicines like Aumolertinib can offer new ways to fight lung cancer.

Taking part in a study like this helps researchers learn more about new treatments. This knowledge is vital for helping people with lung cancer in the future. It's a key step in developing new medicines that could eventually become available to many more patients.

Key takeaways

New medicine (Aumolertinib) for advanced lung cancer.
Specifically for Non-Small Cell Lung Cancer with EGFR mutations.
Early-stage study focused on safety and how the medicine works.
Open to adults aged 18 and over.
Participation involves regular clinic visits and health checks.

Who may be eligible?

To be considered for this study, you must be an adult, aged 18 or older. There is no upper age limit, so older adults can also take part if they meet other requirements.

Participants can be male or female. The main medical requirement is that you have Non-Small Cell Lung Cancer (NSCLC) that has specific genetic changes, known as EGFR mutations, and your cancer is considered advanced.

Other detailed medical checks will be done by the study team to make sure it's safe for you to take part and that the study is right for your specific health situation.

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 18 years old or older?
Have you been diagnosed with Non-Small Cell Lung Cancer?
Does your lung cancer have specific genetic changes (EGFR mutations)?
Is your cancer considered advanced by your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of health checks to see if you are a good fit. These checks might include blood tests, scans, and other examinations. If eligible, you would receive the study medicine, Aumolertinib, usually by mouth. You would have regular visits to the hospital or clinic so the study team can monitor your health, check for any side effects, and see how the medicine is working. These visits might involve more blood tests, scans, and discussions with the doctors. The total duration of your participation, including how long you take the medicine and how often you have follow-up visits, would be fully explained to you before you agree to join.

Potential risks and benefits

Participating in a study like this could potentially offer you access to a new medicine before it's widely available. Researchers will learn valuable information that could help others in the future. However, there are potential risks, as Aumolertinib is a new medicine, and its full effects and side effects are still being investigated. You might experience side effects that are not yet fully known. Also, the medicine may not work for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Bulgaria

Common questions

What kind of lung cancer is this study for?

It's for a type of advanced lung cancer called Non-Small Cell Lung Cancer (NSCLC) that has specific genetic changes (EGFR mutations).

What is Aumolertinib?

Aumolertinib is a new medicine being tested in this study. It's not yet widely available.

Who can take part?

Adults aged 18 and over, both men and women, with the specific type of lung cancer mentioned.

Will I have to travel a lot?

You will need to attend regular hospital or clinic visits for check-ups and to receive the study medicine. The research team will provide details on the frequency and location of these visits.

Is this medicine guaranteed to help me?

No, it's not guaranteed. This is an early-stage study to learn if the medicine is safe and how it works. It may or may not help your specific condition.