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

2 1 1

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

No sites found in this category

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 Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland
Show more
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Hxghmgmi Vxvc dclethni Barcelona Spain
Vljqsm dqq Rvbql Uebnytlvrg Hkrxrdco Sevilla Spain
Iykbgjje Rqplmfrsp Prp Lq Syadgt Dms Tyqjqd Djkt Ablscdf Iwpy Ssybkd Meldola Italy
Hheavdnf Cevgws De Btvomraft Barcelona Spain
Ukscpohxvmtp Db Swbahmib Dr Cwohbihczf Santiago De Compostela Spain
Ugyaccyauaozomztxijqd Wrnmtlugu Acg Wuerzburg Germany
Tdzmqocbaadx Hltbcmygvs gkhnx Heidelberg Germany
Idkrtj Ipsnqfly Fkrtxefyodemr Orvcdxgwpak Rome Italy
Avvejxdiq Kmglcd Gbbjqys Gsbh Gauting Germany
Hmqajvab Ulomrxtwwcznx 1h Dn Oujduhl Madrid Spain
Ffagjtmdcf Ibyhgoetcs Iopaziwd Nrafjkpnyml Bjuue Milan Italy
Cqsfcvv Dr Oxfpghqab Sa Ndpuuhge Shbiyr Craiova Romania
Mbc Poywerd Sox z oppr Poznan Poland
Smtvpqrv Kvbqgaxtkoi Beagzxhcd Flfn Dka Grcycoetlz Miyqe Moers Germany
Cwuqmqq Pqbdrwnj Sakxnc Sibiu Romania
Iwoculhk Do Cyvygfyz Fenyhsjrsl Dyt Plbyggjw Pxw Lsmlqmrluy Ibxgr Candiolo Italy
Ehephqklvsdko Kzyswxzl Berdtw gbhcr Bielefeld Germany
Hdflzjhh Unzbmsvlhbmqq Lghft Apeeugh Lugo Spain
Svndksq Szkkgivlmfitymb W Ptehehnqj Seg z onsl Prabuty Poland
Apkilag Uhixj Sqikkmzwp Lutxoc Dvjxk Raaurht Faenza Italy
Hmkzwzwv Ukejrbkbxxuyl Dg Jedu Jaen Spain
Me Agkmzrnj Cywhhg Czvjyg Madrid Spain
Komsctxc Ebpnkfbhnucybvamaaxdozwo Hoexiaydoocwsdeio Essen Germany
Aalvxxljg Ofvkgodu Timisoara Romania

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.09.2025
Italy Italy
Recruiting
01.09.2025
Poland Poland
Recruiting
01.09.2025
Romania Romania
Recruiting
01.09.2025
Spain Spain
Recruiting
01.09.2025

Trial locations

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)

Other Trials to Consider

  • Study of MK-1084 and Pembrolizumab for First-Line Treatment in Patients with Metastatic Non-Small Cell Lung Cancer with KRAS G12C Mutation and High PD-L1 Levels

    Recruiting

    3 1 1
    Investigated Drugs:
    Austria Bulgaria France Germany Greece Italy +4
  • Study of MK-1084 plus durvalumab versus placebo plus durvalumab in patients with locally advanced KRAS G12C‑mutant non‑small cell lung cancer after chemoradiotherapy

    Recruiting

    3 1 1
    Investigated Drugs:
    France Germany Greece Italy The Netherlands Poland +1