Study of visugromab and nivolumab with or without docetaxel as second-line treatment for patients with metastatic non-squamous non-small cell lung cancer

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What is this study about?

This clinical trial focuses on treating metastatic non-squamous non-small cell lung cancer, a type of lung cancer that has spread to other parts of the body. The study tests a combination of medications: visugromab (also known as CTL-002), nivolumab, and docetaxel. These medications are given through intravenous infusion, which means they are administered directly into a vein.

The purpose of this study is to evaluate how well the combination of visugromab and nivolumab works with or without docetaxel compared to using docetaxel alone in patients who have already received one previous treatment for their cancer. Some patients will receive an inactive substance (placebo) instead of one of the study medications.

The treatment period may last up to 36 months. During the study, patients will receive regular medical examinations and various tests to monitor their health and how well the treatment is working. The medications being tested work in different ways to fight cancer: visugromab is an antibody that targets a specific protein, nivolumab helps the immune system fight cancer cells, and docetaxel is a chemotherapy drug that stops cancer cells from growing.

1 Initial medical assessment

Your doctor will confirm the diagnosis of stage IV non-squamous non-small cell lung cancer

Medical tests will check your organ function, including blood tests for bone marrow function, kidney, liver, and thyroid function

Your medical history will be reviewed to confirm you have received previous treatment that included immunotherapy

2 Treatment group assignment

You will be randomly assigned to one of the treatment groups

The study uses a placebo-controlled design, which means you may receive either active medications or placebo

3 Treatment administration

You will receive medications through intravenous infusion

The treatment may include combinations of: visugromab, nivolumab, and docetaxel

Treatment will continue until specific end points are reached or your doctor determines it should be stopped

4 Regular monitoring

Your tumor response will be assessed using imaging scans

Regular blood tests will monitor your health status

Your doctor will track any side effects you may experience

You will complete questionnaires about your symptoms and well-being

5 Follow-up period

After completing treatment, you will continue to be monitored for safety

Follow-up visits will track your long-term health status

The study is expected to continue until October 2029

Who Can Join the Study?

You must have confirmed stage IV non-squamous non-small cell lung cancer through tissue or cell examination
You must be at least 18 years old when signing the consent form
You must have previously received treatment for metastatic cancer that included immunotherapy (anti-PD(L)1 therapy) for at least 12 weeks
Your previous cancer treatment must have stopped working while you were still receiving immunotherapy
You must have measurable tumors that can be assessed by imaging scans
You must have a life expectancy of at least 3 months as determined by your doctor
Your physical ability status must be good enough to care for yourself (ECOG score of 0 or 1)
You must have adequate organ function, including:
- Healthy blood cell counts
- Good kidney function
- Proper liver function
- Normal thyroid function
- Normal blood clotting ability
Any side effects from previous cancer treatments must have resolved to mild level or returned to normal, except for hair loss and tiredness
If you are a woman who can become pregnant, you must:
- Have a negative pregnancy test within 7 days before starting treatment
- Use effective birth control during the study and for 150-180 days after the last dose
If you are a man with female partners who can become pregnant, you must use effective birth control during the study and for 150-180 days after the last dose
You must be able to understand the study purpose and agree to participate by signing an informed consent form

Who Cannot Join the Study?

Known history of hypersensitivity (severe allergic reactions) to any of the study drugs or their components
Active or untreated brain metastases (cancer that has spread to the brain)
History of other cancers within the last 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
Severe heart conditions, including:
- Heart attack within the last 6 months
- Unstable heart disease
- Uncontrolled high blood pressure
Active or chronic infections, including:
- Hepatitis B
- Hepatitis C
- HIV
Significant liver disease or abnormal liver function tests
Severe kidney problems requiring dialysis
Current participation in other clinical trials or treatment with other investigational drugs within 4 weeks before starting this study
Pregnant or breastfeeding women
Unable to understand or comply with study procedures and requirements

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Hospital Universitario De Jaen	Jaen	Spain
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
MD Anderson Cancer Center	Madrid	Spain
LungenClinic Grosshansdorf GmbH	Grosshansdorf	Germany
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Med Polonia Sp. z o.o.	Poznan	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Evangelisches Klinikum Bethel gGmbH	Bielefeld	Germany
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Oncomed S.R.L.	Timisoara	Romania
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Szpital Specjalistyczny W Prabutach Sp. z o.o.	Prabuty	Poland
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Asklepios Klinik Gauting GmbH	Gauting	Germany
Smrghidh Kcgkdzvieol Bxtzierke Fhdd Dgq Gxgxaiivnf Mmxxb	Moers	Germany
Cjhbbbd Pxaonzsv Swxofn	Sibiu	Romania
Icgkao Iomfsqgm Fxlbzahswssxo Oqasjsvnwnu	Rome	Italy
Irslsshh Rvqkmpzwv Pfg Ly Sxjnyw Djw Tugvhe Dbuh Aeoebkr Ihic Szmojp	Meldola	Italy
Uwjxfeqgtzqlnaszeqoqp Wrhdsfwem Aug	Wuerzburg	Germany
Kwahmpaz Ejaqhgbhjbnkiykcpykjmcue Hmetwxwlozvasgvsk	Essen	Germany
Hgiajghz Vcna dgpjjrhv	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.09.2025
Italy	Recruiting	01.09.2025
Poland	Not yet recruiting	01.09.2025
Romania	Recruiting	01.09.2025
Spain	Recruiting	01.09.2025

Trial locations

Investigated drugs:

Visugromab is an experimental medication being studied for treating non-small cell lung cancer. It works by targeting specific proteins that may help fight cancer cells.

Nivolumab is a type of immunotherapy medication that helps the body’s immune system recognize and fight cancer cells. It works by blocking certain proteins that prevent the immune system from attacking cancer cells.

Docetaxel is a chemotherapy medication used to treat various types of cancer, including lung cancer. It works by interfering with the growth and spread of cancer cells in the body.

Non-small cell lung cancer (NSCLC) – A type of lung cancer that begins in the larger lung cells and grows more slowly than small cell lung cancer. When the cancer spreads beyond the lungs to other parts of the body, it is called metastatic non-squamous NSCLC. The disease typically develops in the cells that line the air passages in the lungs, with non-squamous types including adenocarcinoma and large cell carcinoma. As the disease progresses, cancer cells can break away from the primary tumor and spread through the bloodstream or lymphatic system to other organs. The condition affects the lungs’ ability to function normally and can impact breathing and oxygen exchange.

Trial ID:

2024-516794-70-00

Protocol code:

CTL-002-004

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of visugromab and nivolumab with or without docetaxel as second-line treatment for patients with metastatic non-squamous non-small cell lung cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?