Active not recruitingPHASE2INTERVENTIONAL

NeoTRACK - Dissection of IO Efficacy in NSCLC by Longitudinal tracKing

This study, called NeoTRACK, is for people with specific types of non-small cell lung cancer (NSCLC) that can be removed with surgery. It's looking at a new combination treatment involving standard chemotherapy along with two immune system-boosting drugs, tiragolumab and atezolizumab. Patients will receive these drugs before surgery, and then some patients will continue with the drugs (and sometimes chemotherapy) after surgery. The main goals are to check if this treatment combination is safe, how well it works, and to understand more about how these drugs affect the cancer. We hope to find better ways to treat lung cancer and improve patient outcomes.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrolment target

Start

26 May 2023

Estimated completion

01 Jun 2027

Non-small Cell Lung Cancer

What is this study about?

This clinical trial is designed for people who have a type of lung cancer called non-small cell lung cancer (NSCLC) that doctors believe can be fully removed by surgery. The study wants to find out if giving a combination of treatments before and after surgery is a good and effective way to treat this cancer. The new approach combines standard chemotherapy with two newer drugs, tiragolumab and atezolizumab, which work by boosting your body's immune system to fight cancer.

Here's how it generally works: if you join the study, you'll first receive two cycles (rounds) of the chemotherapy drugs along with tiragolumab and atezolizumab. After this, you'll have surgery to remove the cancer. Depending on whether all cancer cells are gone after surgery, you might receive more cycles of chemotherapy with the two new drugs, followed by just tiragolumab and atezolizumab for up to a year. The study is also collecting samples to help scientists understand why some treatments work better for some people than others, and to look for signs in the body that can predict how well a treatment might work.

The main reasons for doing this study are to see if this combined treatment is safe and can be tolerated well by patients, and how effective it is in treating this type of lung cancer. By studying the cancer at a very detailed level, researchers hope to uncover important information that could lead to more personalised and effective treatments for non-small cell lung cancer in the future.

Key takeaways

This study combines chemotherapy with two immune-boosting drugs for certain lung cancers.
Treatment is given before and potentially after surgery.
The main goals are to check safety, effectiveness, and understand how the drugs work.
Patients will undergo regular check-ups and provide samples.
It's for specific stages of non-small cell lung cancer that can be removed by surgery.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have been diagnosed with a specific type of non-small cell lung cancer (NSCLC) that doctors think can be removed by surgery. Your overall health needs to be good enough to undergo both chemotherapy and surgery, and your important organs like your heart, lungs, liver, and kidneys must be working well enough. You also need to be able to provide certain samples, like blood or tissue, for the study.

There are also specific requirements about how your cancer has been staged and measured, and you shouldn't have any medical conditions that would make the treatment unsafe for you. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective birth control during the study and for a period afterwards. Men in the study who are sexually active with women who could become pregnant also need to use effective birth control.

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 non-small cell lung cancer that your doctor says can be removed with surgery?
Is your general health good enough for surgery and chemotherapy?
Are your heart, lungs, liver, and kidneys working well?
Are you able to agree to use effective birth control if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have some tests to make sure you're suitable. Then, you'll receive two cycles of chemotherapy combined with the study drugs, tiragolumab and atezolizumab. After these treatments, you will have surgery to remove the lung cancer. Following surgery, depending on the results, you may have two more cycles of chemotherapy plus the study drugs, and then continue with just tiragolumab and atezolizumab for up to one year. If all cancer cells are removed by surgery, you might only receive the study drugs without further chemotherapy.

Throughout the study, you'll have regular hospital visits for your treatments, follow-up checks, and examinations. You'll also be asked to provide blood and tissue samples. The total length of your participation will vary, but for some, it could involve treatment for up to a year, followed by ongoing check-ups. You can withdraw from the study at any time.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new and innovative treatments before they are widely available. You'll also receive close medical attention and monitoring. However, there are potential risks, as these treatments may have side effects that are not yet fully known or could be severe. There's no guarantee that the treatment will be effective for your specific cancer. It's important to discuss all potential benefits and risks with your doctor. Remember, you can choose to leave the study at any point if you wish.

Locations (2)

Universitätsklinikum Essen (AöR)-Westdeutsches Tumorzentrum Essen
Verified postcode
Essen, Germany
Thoraxklinik Heidelberg
Verified postcode
Heidelberg, Germany

Common questions

What is Non-Small Cell Lung Cancer (NSCLC)?

NSCLC is the most common type of lung cancer. This study focuses on certain stages of NSCLC that doctors think can be treated with surgery.

What are tiragolumab and atezolizumab?

These are drugs that work with your immune system to help it fight cancer cells more effectively. They are designed to boost your body's natural defences.

What does 'neoadjuvant' and 'adjuvant' mean?

'Neoadjuvant' means receiving treatment before surgery to help shrink the tumour, and 'adjuvant' means receiving treatment after surgery to help prevent the cancer from coming back.

Will I still have standard chemotherapy?

Yes, this study involves combining standard platinum-based chemotherapy with the new drugs, both before and potentially after surgery.

Can I stop participating in the study if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.