Active not recruitingPHASE2INTERVENTIONAL

Multimodality Treatment in Stage III Non-small Cell Lung Cancer (NSCLC)

This study is for people with a type of lung cancer called non-small cell lung cancer (NSCLC) that can be removed with surgery but has also spread to nearby lymph nodes. Even after standard treatments, this cancer can sometimes come back. The study aims to find out if adding an immunotherapy drug called durvalumab, along with special radiation therapy, to standard chemotherapy before surgery can reduce this risk. Researchers believe radiation might help the immunotherapy drug work better by making cancer cells more visible to the body's immune system. They are testing three different ways of giving this radiation therapy to see which is most effective and easiest to tolerate, hoping to improve treatment outcomes for patients.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Swiss Cancer Institute

Enrolment target

Start

15 Jul 2020

Estimated completion

01 Dec 2031

Non-small Cell Lung Cancer NSCLC

What is this study about?

This study is looking at a type of lung cancer called non-small cell lung cancer, which is found to have spread to nearby lymph nodes in the chest. While surgery to remove the cancer is often an option, there's a risk that the cancer might return.

Currently, patients often receive chemotherapy before surgery. This study wants to see if adding two other treatments beforehand might improve the chances of keeping the cancer away. These include an immunotherapy drug called durvalumab and a special type of radiation therapy. Immunotherapy helps your body's own immune system fight cancer, and researchers think that radiation might make the cancer cells more visible to these immune cells, helping the treatment work even better. They are testing three different schedules for the radiation therapy to find the best approach.

The main goal is to find out if this combination of treatments (chemotherapy, immunotherapy, and radiation) is safe and more effective at preventing the cancer from coming back. By studying how these treatments work together, especially before surgery, doctors hope to develop better ways to treat this type of lung cancer in the future.

Key takeaways

This study combines chemotherapy, immunotherapy (durvalumab), and radiation before lung cancer surgery.
It's for a specific type of non-small cell lung cancer that has spread to nearby lymph nodes but is still removable.
Researchers are testing three different ways of giving radiation to see which is best.
The main goal is to find out if this new combination is safer and more effective at preventing cancer from returning.
Participation means receiving these treatments, followed by surgery, and regular check-ups.

Who may be eligible?

To join this study, you would need to have been diagnosed with non-small cell lung cancer that can be removed by surgery but has spread to lymph nodes in your chest. Your doctors would need to agree that surgery is a good option for you after the initial treatments in the study. You must be between 18 and 75 years old.

There are also some general health requirements. Your blood tests, including those for your blood count, kidney, and liver function, would need to be within a healthy range. You'd also need to be able to do your usual daily activities without too much difficulty, or only with a little help.

Before you can join, you'll have a meeting to discuss the study in detail and sign a consent form. This ensures you understand what's involved.

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.

Have you been diagnosed with non-small cell lung cancer that your doctor believes can be surgically removed?
Has your cancer spread to lymph nodes in your chest?
Are you between 18 and 75 years old?
Are you generally well and able to carry out most of your daily activities?
Do your latest blood test results show your organs (kidney, liver) and blood count are working well?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first receive a combination of treatments before your surgery. This involves:

* **Chemotherapy:** You'd have three cycles of chemotherapy, with each cycle lasting 21 days. * **Immunotherapy:** You'd receive one cycle of the immunotherapy drug, durvalumab. * **Radiation Therapy:** You would also have radiation therapy. This will happen at the same time as your immunotherapy. You'd be randomly assigned to one of three different radiation schedules: either daily for four weeks, daily for one week, or on alternate days for two weeks. This is to see which schedule works best.

After these treatments, you would have your surgery as planned. Throughout the study, you would have various medical appointments for assessments, blood tests, and scans to monitor your health and how the treatment is working. The specific number of visits and their timing would be explained to you in detail. The total duration of your participation, including follow-up after surgery, would be part of the full study information.

Potential risks and benefits

Participating in this study might offer the benefit of receiving new treatments that could be more effective for your cancer than standard care alone. However, like all medical treatments, there are potential risks and side effects associated with chemotherapy, immunotherapy, and radiation therapy. These will be fully explained to you before you decide to join. It is important to remember that you can choose to leave the study at any time, for any reason, without it affecting the standard medical care you would otherwise receive.

Locations (13)

Universitätsklinikum Tübingen
Verified postcode
Tübingen, Germany
Kantonsspital Aarau
Verified postcode
Aarau, Switzerland
Kantonsspital Baden
Verified postcode
Baden, Switzerland
St. Claraspital Basel
Verified postcode
Basel, Switzerland
Universitaetsspital Basel
Verified postcode
Basel, Switzerland
IOSI Ospedale Regionale di Bellinzona e Valli
Verified postcode
Bellinzona, Switzerland
Inselspital
Verified postcode
Bern, Switzerland
Kantonsspital Graubuenden
Verified postcode
Chur, Switzerland
Hôpitaux Universitaires de Genève
Verified postcode
Geneva, Switzerland
Kantonsspital - St. Gallen
Verified postcode
Sankt Gallen, Switzerland
Regionalspital Thun
Verified postcode
Thun, Switzerland
Stadtspital Triemli
Verified postcode
Zurich, Switzerland

Common questions

What is non-small cell lung cancer (NSCLC)?

It's the most common type of lung cancer. This study focuses on a stage where it has spread to nearby lymph nodes but can still be removed by surgery.

What is immunotherapy?

Immunotherapy is a treatment that helps your body's own immune system find and fight cancer cells more effectively.

What is 'neoadjuvant' treatment?

This means you receive treatment, like chemotherapy, immunotherapy, or radiation, before your main treatment, which in this case is surgery.

Why are they testing three different types of radiation therapy?

The researchers want to find the best way to give radiation alongside immunotherapy to make the combined treatment as effective as possible, without causing too many side effects.

Will I have to pay to be part of the study?

No, you will not have to pay for the study treatments or assessments. These are covered by the study.