AuthorisedTherapeutic exploratory (Phase II)Interventional

Phase II, open label, single arm, multicenter study to assess the activity and safety of ALectinib as NE O adjuvant therapy in patients with anaplastic lymphoma kinase positive (ALK+) locally advanced Stage III Non Small Cell Lung Cancer (NSCLC): ALNEO trial-GOIRC-01-2020

This study, called ALNEO, is for people in the UK who have a type of lung cancer known as ALK-positive Stage III Non-Small Cell Lung Cancer. Researchers are testing a new drug called ALECTINIB. The main goal is to find out how effective this medicine is at shrinking the tumour before surgery, and to understand if it's safe for patients. We'll be looking closely at the tumour after surgery to see how much of it has gone. This is a Phase II study, which means we're exploring if this treatment works well, and gathering more information about its safety and effects in patients before it can be more widely used. We also want to see if the drug can completely get rid of all cancer cells in the treated areas.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

Enrolment target

Start

02 Dec 2024

Patients with anaplastic lymphoma kinase positive (ALK+) locally advanced Stage III Non Small Cell Lung Cancer (NSCLC)

What is this study about?

This study is looking into a new approach for treating a specific kind of lung cancer called ALK-positive Stage III Non-Small Cell Lung Cancer. If you have this type of cancer, it means that your cancer cells have a particular change in their genes (called ALK-positive) and the cancer is considered to be 'locally advanced Stage III'. This means it hasn't spread far but is affecting areas close to the lung.

The main idea behind this study is to give patients a specific medicine, called ALECTINIB, before they have surgery. This type of treatment, given before a main treatment like surgery, is sometimes called 'neoadjuvant therapy'. The hope is that by taking ALECTINIB first, the tumour will shrink, making the surgery more successful in removing all the cancer cells. Researchers will then carefully check the removed tumour tissue after surgery to see how much of the cancer has gone away. They will also keep a close eye on any side effects to make sure the treatment is safe.

This is a 'Phase II' study. In clinical trials, new treatments go through different stages. Phase II studies are about exploring if a treatment works for a specific condition and gathering more information about its safety and best dose, after it has been shown to be safe in a smaller group of people. So, this study is a step in understanding if ALECTINIB could be a helpful new treatment option for people with this particular type of lung cancer.

Key takeaways

This study tests a new drug, ALECTINIB, for a specific type of lung cancer (ALK+ Stage III NSCLC).
It aims to see if giving ALECTINIB before surgery shrinks tumours effectively.
The study also looks at the safety of ALECTINIB.
It's open to adults aged 18 and over, both men and women.
Participation involves taking medication, regular hospital visits, and follow-up after surgery.

Who may be eligible?

To join this study, people need to be adults, aged 18 or older – there's no upper age limit. Both men and women are welcome to take part.

The study is specifically for people who have been diagnosed with a certain type of lung cancer. This is called 'ALK-positive Stage III Non-Small Cell Lung Cancer'. Your doctor will be able to confirm if your cancer fits this description based on your test results.

There might be other health requirements or previous treatments that could affect whether you can join, but the doctors running the study will check all these details with you carefully.

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?
Do you have ALK-positive Stage III Non-Small Cell Lung Cancer?
Are you able to undergo surgery for your lung cancer?
Are you willing to take a medication before your surgery?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given the medication ALECTINIB. This would happen before you have your surgery. You would have regular visits with the study team at a hospital to monitor your health, check for side effects, and see how the treatment is working. These visits would likely include blood tests, scans, and other medical examinations.

After your surgery, the doctors will carefully examine the removed tumour. You would then continue to be monitored for a period to see how you are recovering and if there are any long-term effects of the treatment. The total duration of your participation in the study, including the follow-up, would be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new treatment that might be more effective than existing options for your specific cancer. You would also be closely monitored by a team of medical experts. However, like all medicines, ALECTINIB may have side effects, and there's no guarantee that it will work for everyone, or that it will be better than standard treatments. You will be fully informed about all known risks before you decide to take part, and 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
Italy

Common questions

What does 'ALK-positive' mean for my lung cancer?

It means your cancer cells have a specific genetic change (a problem with the ALK gene) that helps the cancer grow. This study is looking at a medicine designed to target this specific change.

What does 'Stage III Non-Small Cell Lung Cancer' mean?

Non-Small Cell Lung Cancer is the most common type of lung cancer. Stage III means the cancer is locally advanced, meaning it's in the lung and nearby areas but hasn't spread widely to other parts of the body.

What is ALECTINIB?

ALECTINIB is a medicine that specifically targets cancer cells with the ALK gene change, aiming to stop them from growing and spreading.

Why would I take medicine before surgery?

Taking medicine before surgery is called 'neoadjuvant therapy'. The idea is to shrink the cancer first, which could make the surgery more successful and remove more cancer cells.

What will doctors be looking for after my surgery?

After your surgery, doctors will carefully examine the removed tumour tissue. They'll be looking to see how much of the cancer has been shrunk or completely removed by the ALECTINIB treatment.