RecruitingPHASE2INTERVENTIONAL

Immunochemotherapy, Surgery or Chemoradiation, and Durvalumab for Stage IIIA/B NSCLC

This clinical trial is looking at a new way to treat non-small cell lung cancer (NSCLC) that is at a stage called IIIA/B. Researchers want to see if combining several treatments, starting with a special type of chemotherapy (that also uses immunotherapy drugs), followed by either surgery or radiation therapy, and then more immunotherapy, works better than current treatments. The main goal is to find out if this new approach helps patients live longer without their cancer coming back. It's a Phase 2 study, meaning it's still in the earlier stages of testing to see if the treatment is safe and effective in a larger group of people.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital, Bonn

Enrolment target

176

Start

20 Apr 2025

Estimated completion

30 Sep 2030

Lung Cancer Non-Small Cell Cancer (NSCLC)

What is this study about?

This study is investigating a new way to treat a specific type of lung cancer called non-small cell lung cancer (NSCLC), which is at stages IIIA or IIIB. At these stages, the cancer is quite advanced but might still be treatable. The current standard treatments can be helpful, but doctors are always looking for ways to make them even better.

The researchers in this trial believe that combining different types of treatments might be more effective than what's currently available. They are testing a step-by-step approach: first, a combination of chemotherapy and immunotherapy (drugs that help your body's immune system fight cancer), then either surgery to remove the cancer or radiation therapy to kill cancer cells, and finally, more immunotherapy with a drug called Durvalumab. The main aim is to see if this new combination helps people live longer without their cancer coming back.

This is a Phase 2 study, which means it’s designed to learn more about how well this new treatment works and if it's safe. It's an important step in developing new and potentially improved treatments for lung cancer. The hope is that this new strategy could significantly improve the chances of a good outcome for patients with this type of lung cancer.

Key takeaways

This study is for people with specific advanced stages (IIIA/B) of non-small cell lung cancer.
It tests a new combination of chemotherapy, immunotherapy, and either surgery or radiation.
The main goal is to see if this new treatment helps patients live longer without their cancer coming back.
Participation involves strict eligibility checks and regular hospital visits.
This is a Phase 2 trial, meaning it's an important step in testing new treatments.
Patient safety and close monitoring are key parts of the study design.

Who may be eligible?

To join this study, you generally need to be an adult between 18 and 74 years old. You must have a confirmed diagnosis of non-small cell lung cancer (NSCLC) at stage IIIA or IIIB, and your cancer shouldn't have certain genetic changes (EGFRm- or ALK-). Your general health should be good enough to undergo the treatments in the study, and your doctor must believe that surgery could potentially remove all of your cancer.

There are also some important safety requirements. If you are a woman who could become pregnant, or a man whose partner could become pregnant, you would need to use highly effective birth control throughout the study and for a period afterwards. This is to prevent pregnancy because the study drugs could harm an unborn baby. Your medical team will check your overall health, including how well your organs are working, to make sure it's safe for you to participate.

Before you can join, you'll have to read and sign a consent form. This form explains all the details of the study, including what would be expected of you, any potential risks, and your rights as a participant. Taking the time to understand this form and asking any questions you have is very important.

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 between 18 and 74 years old?
Do you have confirmed non-small cell lung cancer at stage IIIA or IIIB (without specific genetic changes)?
Is your general health good enough for treatments like chemotherapy and surgery?
Are you able to use effective contraception if you or your partner could become pregnant?
Are you willing to follow all study instructions and attend regular appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you meet all the requirements. Once confirmed, you would receive a sequence of treatments. This involves an initial period of combined chemotherapy and immunotherapy. Following that, depending on your specific situation and the study's plan for you, you would either have surgery to remove the tumour or undergo radiation therapy.

After these initial treatments, you would then receive an immunotherapy drug called Durvalumab for a period of time. Throughout the study, you'd have regular visits to the hospital or clinic for blood tests, scans, and check-ups to monitor your health, how the treatment is working, and to manage any side effects. The exact number of visits and the total duration in the study would be explained in detail by the study team, but typically, clinical trials involve ongoing monitoring for several months or even a few years.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as receiving a new treatment that might be more effective than current options for your type of cancer. It also means you’d be closely monitored by a dedicated medical team. However, there are also potential risks; the new treatments might have side effects that are different from or more severe than standard treatments, and there's no guarantee the treatment will 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 (5)

University Hospital Freiburg
Verified postcode
Freiburg im Breisgau, Germany· Recruiting
Klinikum Stuttgart
Verified postcode
Stuttgart, Germany· Recruiting
University Hospital Gießen
Verified postcode
Giessen, Germany· Not yet recruiting
Johannes Wesling Klinikum Minden Mühlenkreiskliniken, Hämatologie und Onkologie
Verified postcode
Minden, Germany· Recruiting
University Hospital Bonn
Verified postcode
Bonn, Germany· Recruiting

Common questions

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

It's the most common type of lung cancer. This study focuses on specific advanced stages (IIIA/B).

What is immunotherapy?

Immunotherapy uses your body's own immune system to find and fight cancer cells.

What does 'Phase 2' mean for a trial?

Phase 2 means the study is testing if a new treatment is safe and effective in a larger group of people, after earlier safety tests.

Will I definitely receive the new treatment combination?

Yes, all participants in this study would receive the new combination of treatments being tested.

What if I change my mind about participating?

You can withdraw from the study at any time without having to give a reason, and it won't affect your future medical care.

How to find out more

Eleni Gkika, Prof. Dr. med.

eleni.gkika@ukbonn.de 0049 22825710353 Official trial record

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