RecruitingOBSERVATIONAL

Prospective Trial of Induction Immunotherapy in Locally Advanced or Oligometastatic NSCLC Without a Primary Curative Option

This study is for people with a type of lung cancer called non-small cell lung cancer (NSCLC). It focuses on cancers that are advanced or have spread a little, making them difficult to treat with surgery or strong radiation and chemotherapy straight away. The study aims to see if giving a special type of medicine called immunotherapy (sometimes with chemotherapy) first can make the cancer shrink. If it shrinks, doctors might then be able to use standard treatments like surgery or radiation with a better chance of success. The approach allows doctors to re-evaluate the cancer's response and decide on the best next steps, potentially offering new hope for those who can't have immediate curative options.

At a glance

Status

Recruiting

Sponsor

Klinikum Esslingen

Enrolment target

Start

15 Dec 2017

Estimated completion

31 Dec 2027

Carcinoma, Non-Small-Cell Lung

What is this study about?

This study is all about trying a new approach for people with a specific type of lung cancer called non-small cell lung cancer (NSCLC). This is the most common kind of lung cancer. Sometimes, when the cancer has grown quite large or has spread to a few nearby spots (which doctors call 'oligometastatic'), it can be too difficult for doctors to remove it all with surgery or treat it effectively with just radiation and chemotherapy right from the start. This might be because the tumour is very big, or perhaps a person's body might not be able to handle a very intense treatment purely due to other health reasons.

In this study, instead of going straight to surgery or high-dose radiation, doctors are giving a special kind of medicine called 'immunotherapy' first. Immunotherapy works by helping your body's own immune system fight the cancer cells. Sometimes, a combination of immunotherapy and chemotherapy is used. The main idea is to see if these medicines can shrink the cancer significantly enough so that, afterwards, the standard treatments like surgery or radiation and chemotherapy become possible and more effective.

After a period of this initial treatment, doctors will carefully check the cancer using scans. A team of specialists will then review everything to decide if the cancer has shrunk enough for the patient to go on to receive surgery or definitive radiation/chemotherapy with the aim of a cure. If not, they will discuss other appropriate care. This study is important because it's trying to find better ways to treat lung cancers that are currently very challenging to cure.

Key takeaways

This study explores a new first step for certain lung cancers.
It uses immunotherapy (sometimes with chemotherapy) to shrink tumours.
The goal is to make surgery or strong radiation/chemotherapy possible later.
It's for people whose cancer is hard to treat with standard methods initially.
Decisions about next steps are made by a team of cancer specialists.

Who may be eligible?

To join this study, people must have been recently diagnosed with non-small cell lung cancer that has been confirmed by lab tests. The cancer needs to be at a stage where it's advanced or has spread slightly to a few places, but not widely throughout the body. Importantly, participants must be those who cannot have the standard direct treatments like surgery or high-dose radiation right away, because of the size of their tumour or how healthy they are overall.

Patients should generally be able to look after themselves with little or no help, and doctors expect them to live for at least three months. You also need to be willing and able to understand and sign a consent form, which means you agree to take part.

You would not be able to join if your cancer could be easily removed by surgery at the start, or if you could safely have strong radiation and chemotherapy as your first treatment. The study is open to both men and women aged 18 or older.

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 recently diagnosed with non-small cell lung cancer?
Has your cancer been confirmed by a biopsy or cell test?
Is your cancer at a stage where it's advanced or has spread slightly (oligometastatic)?
Have doctors told you that surgery or high-dose radiation isn't suitable for you as a first treatment?
Are you generally able to look after yourself and are 18 years or older?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first receive a special type of medicine called immunotherapy, sometimes combined with chemotherapy. This treatment is given to try and shrink your cancer. During this initial treatment phase, you would have regular hospital visits for your medicine and check-ups. Doctors will assess how the treatment is working using scans, likely including a PET-CT scan if needed, to see if your cancer is shrinking.

After this initial treatment, a team of cancer specialists will review your scans and discuss the next steps. They will decide if your cancer has responded well enough for you to then have a standard treatment that aims to cure, such as surgery or strong radiation and chemotherapy. If not, they will discuss other treatment options to manage your cancer. The total duration of your participation would depend on how your cancer responds and what subsequent treatments are recommended.

Potential risks and benefits

Taking part in this study may offer the potential benefit of shrinking your cancer and making it more treatable, particularly if standard curative treatments aren't an option for you at first. Immunotherapy, like any medicine, can have side effects, which can range from mild to severe, including feeling tired, skin rashes, or more serious reactions involving different body organs; your doctors will discuss these with you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Klinikum Esslingen
Verified postcode
Esslingen am Neckar, Germany· Recruiting

Common questions

What is 'non-small cell lung cancer'?

It's the most common type of lung cancer, distinct from 'small cell lung cancer' under the microscope.

What does 'immunotherapy' mean?

It's a treatment that helps your own body's defence system (immune system) recognise and fight cancer cells.

What does 'oligometastatic' mean?

It means the cancer has spread to a few nearby spots, but not widely throughout the body.

Will I definitely get a cure if I join this study?

The study aims to make curative treatments possible, but it doesn't guarantee a cure. It's exploring if initial treatment can improve chances.

Can I choose not to have chemotherapy if immunotherapy is an option?

Your doctors will discuss whether immunotherapy alone or with chemotherapy is recommended based on your specific situation. This study uses either approach.

How to find out more

Martin Faehling, MD, MSc

m.faehling@klinikum-esslingen.de +49711310382411 Official trial record

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