RecruitingPHASE2INTERVENTIONAL

Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC

This study is looking for new ways to treat advanced lung cancer (non-small cell lung cancer that has spread and is not squamous type). It focuses on people whose cancer has already been treated with one type of immunotherapy, but that treatment didn't work well enough. The study is testing a new drug called Visugromab, at different doses, alongside an existing immunotherapy drug called Nivolumab. Some patients will also receive a chemotherapy drug called Docetaxel. The main goal is to see if these new combinations are safe and if they show promise in treating this type of cancer. It's a randomised study, meaning treatments are chosen by chance, and some people will receive a placebo (dummy treatment) to help compare the results fairly.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

CatalYm GmbH

Enrolment target

131

Start

07 Oct 2025

Estimated completion

01 Oct 2031

Metastatic Non-Squamous Non-Small Cell Lung Cancer Adult Solid Tumor

What is this study about?

This research study is for people in the UK who have a type of advanced lung cancer called non-small cell lung cancer, which has spread to other parts of the body. Specifically, it's for those whose cancer isn't the 'squamous' type and whose previous treatment for advanced cancer, which included an immunotherapy drug (a checkpoint inhibitor), didn't work as hoped.

The main aim of this study is to explore new treatment combinations. We're testing a new medication called Visugromab, alongside another immunotherapy drug called Nivolumab. Some groups in the study will also receive a chemotherapy drug called Docetaxel. The researchers want to find out how safe these new combinations are and if they can effectively fight the cancer. The study is particularly interested in finding early signs of how well these treatments work in different doses and combinations.

To make sure the results are as clear and reliable as possible, the study is designed to be 'randomised' and 'blinded'. This means that treatment options are chosen by chance, like flipping a coin, and neither you nor your study doctor will know which specific treatment you are receiving until after the study is over, or if there's a medical need to find out. This helps to prevent any bias in the results. There will be different groups, and some will receive the new drug combinations, while others might receive a standard treatment plus a placebo (a dummy treatment that looks like the active drug but has no medicine in it).

Key takeaways

This study is for advanced, non-squamous non-small cell lung cancer that has spread.
It’s for people whose previous immunotherapy treatment didn't work well enough.
The study tests new drug combinations, including Visugromab, Nivolumab, and sometimes Docetaxel.
Its main aim is to check the safety and potential effectiveness of these new treatments.
Treatment groups are chosen by chance, and some people may receive a placebo.
You'll have regular hospital visits for treatment, monitoring, and check-ups.

Who may be eligible?

To join this study, you would need to have a specific type of advanced lung cancer that has spread, and your doctors would have confirmed it under a microscope. You must have already tried one type of treatment for your advanced lung cancer that included an immunotherapy drug, and that treatment wasn't fully successful. Your doctors will also need to confirm that your cancer doesn't have certain genetic changes that would mean other specific treatments would be better for you.

Your general health and fitness for the study will be checked. This includes having a measure of your cancer that can be seen and tracked on scans, and your doctor thinking you have a reasonable life expectancy (at least 3 months). You also need to be able to carry out most of your daily activities without too much difficulty. For safety reasons, you can't have had more than one previous treatment for your advanced lung cancer, or have certain other medical conditions like active autoimmune diseases, specific brain involvement from your cancer, or certain lung conditions, as these could make the study treatments unsafe for you. You also cannot have had another cancer in the past that needed treatment.

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 advanced lung cancer that has spread, and is it a 'non-squamous' type?
Have you already received one treatment for your advanced lung cancer that included an immunotherapy drug, but it wasn't fully successful?
Does your doctor confirm that your cancer doesn't have specific genetic changes that would lead to other targeted treatments?
Are you generally well enough to participate in a study, and able to carry out most daily activities?
Do you have measurable cancer that can be tracked on scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of several treatment groups by chance. You will receive either the new study drugs (Visugromab and Nivolumab, sometimes with Docetaxel), or a combination that includes a placebo (a dummy treatment). The study drugs will be given as infusions (through a drip into your vein) over a period of time. You will have regular visits to the hospital for these treatments, as well as for check-ups, blood tests, and scans to monitor your health and how the treatment is working. The study is divided into different parts, with initial safety checks and then a larger main study. Your participation will involve ongoing treatment and follow-up until your doctors decide it's no longer benefiting you, or until the study concludes. The exact duration of your participation will depend on how you respond to the treatment and the study's overall timeline.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from receiving new treatments that are not yet widely available, and these treatments might help control your cancer. However, there's no guarantee that the study treatments will work for you. Like all medications, the study drugs can have side effects, which could range from mild to serious. Your study team will explain all known potential side effects to you. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care. Your safety and well-being will be closely monitored throughout the study.

Locations (25)

University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)
Verified postcode
Birmingham, United States· Recruiting
USC Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Recruiting
NYU Longone Health
Verified postcode
New York, United States· Recruiting
Duke University Medical Center
Verified postcode
Durham, United States· Recruiting
Hospital Esslingen GmbH
Verified postcode
Esslingen am Neckar, Germany· Recruiting
University Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical Immunology
Verified postcode
Würzburg, Germany· Recruiting
Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift
Verified postcode
Bielefeld, Germany· Recruiting
Clinics Essen-Mitte
Verified postcode
Essen, Germany· Recruiting
Foundation Bethanien Moers
Verified postcode
Moers, Germany· Recruiting
Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRST
Verified postcode
Forlì, Italy· Recruiting
Oncology Reference Center
Verified postcode
Aviano, Italy· Recruiting
National Cancer Institute Regina Elena, IRCCS
Verified postcode
Rome, Italy· Recruiting

Common questions

What is 'advanced lung cancer'?

This means your lung cancer has spread from where it started to other parts of your body. It's also called 'metastatic' cancer.

What does 'non-squamous' mean for lung cancer?

Lung cancer is divided into different types. 'Non-squamous' is a common type that doesn't look like 'squamous' cells under a microscope. This study is specifically for the non-squamous type.

What is a 'checkpoint inhibitor'?

It's a type of immunotherapy drug that helps your own immune system recognise and fight cancer cells. You would have had one of these before joining this study.

What is a 'placebo'?

A placebo is a substance that looks exactly like the real drug but contains no active medicine. It's used in some parts of the study to help compare the new treatments fairly.

Will I know which treatment I'm getting?

This is a 'blinded' study, so neither you nor your study doctor will know which specific treatment you are receiving until after the study is over, unless there's a medical reason to find out.

How to find out more

Lena Lemke, MD

regulatory-004@catalym.com +49 89 200066440 Official trial record

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