Not yet recruitingOBSERVATIONAL

Immune-Marker Platform for Patients With Advanced Lung Cancer

This study aims to understand how your immune system and specific markers in your tumour affect how you respond to treatment for advanced non-small cell lung cancer (NSCLC). Doctors want to see if they can identify special signals within your tumour that predict whether a treatment will be effective. This isn't a new drug trial; instead, it's about learning more from existing treatments to help future patients. By studying small samples of your tumour before, during, and after treatment, researchers hope to find better ways to personalise treatment plans and improve care for people with this type of lung cancer.

At a glance

Status

Not yet recruiting

Sponsor

Technische Universität Dresden

Enrolment target

500

Start

01 Sep 2025

Estimated completion

01 Jun 2027

NSCLC (Advanced Non-small Cell Lung Cancer)NSCLC Stage IIIB~IV NSCLC Non-small Cell Lung Cancer

What is this study about?

This research study is about understanding advanced non-small cell lung cancer (NSCLC) better. NSCLC is a common type of lung cancer, and 'advanced' means it has spread or is difficult to treat with surgery alone. The study focuses on a specific type of treatment called immunochemotherapy, which combines chemotherapy (drugs that kill cancer cells) with immunotherapy (drugs that help your own immune system fight cancer).

The main goal is to figure out if there are certain 'markers' in your tumour or in your immune system that can tell us how well a patient might respond to this treatment. Think of these markers like clues; by finding these clues, doctors hope to predict who will benefit most from immunochemotherapy and understand why some treatments work better for some people than others. This isn't about testing a brand-new medicine, but rather about learning more from treatments already in use to improve future care.

Researchers will look at tiny bits of your tumour tissue to see what's happening inside – for example, what genes are active or how your immune cells are behaving. They will then compare these findings with how patients respond to their treatment. This will help them to understand the disease and its treatments in a more detailed way, potentially leading to more personalised and effective care for people with advanced lung cancer in the future.

Key takeaways

This study helps doctors understand advanced lung cancer better.
It's about studying existing immunochemotherapy treatments, not new ones.
Researchers look for 'markers' in your tumour to predict treatment response.
You would provide small tumour samples (biopsies) at key times.
This research aims to improve future care for lung cancer patients.

Who may be eligible?

This study is for adults aged 18 or over who have advanced non-small cell lung cancer (NSCLC) that can't be cured. You must not have certain common genetic changes in your cancer that can be targeted with other specific drugs. Also, your cancer's PD-L1 expression (a marker related to how immunotherapy works) must be less than 50%.

There are two groups in the study. If you're in Cohort A, you haven't started treatment for your advanced lung cancer yet. If you're in Cohort B, you've already had first-line immunochemotherapy and your cancer has progressed.

You cannot take part if a doctor thinks getting an extra tumour sample would be too risky for you, or if you can't understand what the study involves. Certain issues like drug or alcohol misuse, or other medical/mental health conditions that might stop you from taking part safely, would also prevent you from joining.

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 advanced non-small cell lung cancer that cannot be cured?
Does your cancer not have certain common genetic changes that can be treated with targeted drugs?
Do you have a PD-L1 expression on your tumour cells of less than 50%?
Are you able and willing to have tumour biopsies as required by the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be asked to provide small samples of your tumour tissue. This will usually involve a procedure called a biopsy. You would have a biopsy before you start your immunochemotherapy, another one about six weeks after starting treatment, and potentially another if your cancer progresses or your treatment changes. These samples will be analysed by researchers in a laboratory to look for immune and genetic markers. You'll also be asked to share information about your treatment response and how your illness is progressing, which the researchers will link to the findings from your tumour samples. This study does not involve taking any new medications or treatments; it's about studying the treatments you are already receiving.

Potential risks and benefits

Taking part in this study won't offer a direct medical benefit to you, as it's not testing a new treatment. However, the information gathered could greatly help doctors understand advanced lung cancer better and improve care for future patients. The main risk involves the biopsy procedures, which carry a small chance of pain, bleeding, or infection, as with any medical procedure that takes a small tissue sample. Your doctor will discuss these risks with you before you agree to any biopsy. Please remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (2)

Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) Köln
Verified postcode
Cologne, Germany
Universitätsklinikum Carl Gustav Carus
Verified postcode
Dresden, Germany

Common questions

What kind of lung cancer is this study about?

It's about advanced non-small cell lung cancer (NSCLC), which is a common type of lung cancer that has spread or is difficult to cure with surgery.

Will I get a new treatment in this study?

No, this study isn't testing new treatments. It's about learning more from the treatments you're already receiving, specifically immunochemotherapy.

What does 'immune-marker' mean?

It refers to special signals or characteristics in your tumour or immune system that doctors hope can predict how you'll respond to treatment.

What will I have to do if I join?

You'll provide small tumour samples (biopsies) at different times during your treatment, and share information about how your cancer is responding.

Will this study directly help me?

Not directly at the time of the study, as it's for research. But the information gained could lead to better treatments and care for others with lung cancer in the future.

How to find out more

Martin Wermke, Prof. Dr.

impalux-studie@ukdd.de +49 351 458 16226 Official trial record

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