Study on Visugromab with Pembrolizumab, Pemetrexed, and Carboplatin for First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as metastatic non-squamous non-small cell lung cancer (NSCLC). This is a form of lung cancer that has spread to other parts of the body and does not involve squamous cells, which are flat cells found in the lining of the airways. The study will test a new treatment called Visugromab (CTL-002), which is a special type of protein designed to help the immune system fight cancer. This treatment will be given in combination with other medications: Pembrolizumab, Pemetrexed, and Carboplatin. These medications are part of a group of treatments known as immunochemotherapy, which combines immune system-based treatments with chemotherapy to target cancer cells more effectively.

The purpose of the study is to investigate how well Visugromab works when used with these other treatments compared to a placebo, which is a substance with no active medication. Participants in the study will receive either Visugromab or a placebo, along with Pembrolizumab, Pemetrexed, and Carboplatin. The study will be conducted over a period of time, with regular check-ups and assessments to monitor the effects of the treatment on the cancer and any side effects that may occur. The goal is to see if the combination of these treatments can improve the response to cancer and help manage the disease more effectively.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how the treatment affects their cancer. The study aims to provide valuable insights into the potential benefits of using Visugromab in combination with other treatments for people with metastatic non-squamous non-small cell lung cancer. This research could lead to new and improved treatment options for patients with this type of lung cancer in the future.

1 joining the trial

Upon joining the trial, you will be randomly assigned to receive either the experimental drug visugromab or a placebo. This process is blinded, meaning neither you nor the medical staff will know which one you are receiving to ensure unbiased results.

2 treatment initiation

You will begin treatment with a combination of medications administered through an intravenous (IV) line. This includes pembrolizumab, pemetrexed, and carboplatin, along with either visugromab or a placebo.

The medications are given as a solution for infusion, which means they are delivered directly into your bloodstream through a vein.

3 medication schedule

The treatment is administered in cycles. Each cycle lasts for a specific period, after which the process is repeated. The exact duration and frequency of each cycle will be explained to you by the medical team.

The dosage of each medication is carefully calculated based on your specific medical condition and overall health.

4 monitoring and assessments

Throughout the trial, regular monitoring and assessments will be conducted to evaluate your response to the treatment. This includes physical examinations, blood tests, and imaging studies such as CT scans.

You will also be asked to complete questionnaires about your symptoms and quality of life to help assess the impact of the treatment.

5 follow-up visits

You will have scheduled follow-up visits with the medical team to discuss your progress and any side effects you may experience. These visits are crucial for ensuring your safety and the effectiveness of the treatment.

The medical team will provide guidance on managing any side effects and adjusting the treatment plan if necessary.

6 end of treatment

At the end of the treatment period, a final assessment will be conducted to evaluate the overall response to the therapy.

You will receive information on any further steps or additional follow-up that may be required based on your individual health needs.

Who Can Join the Study?

Must have a confirmed diagnosis of stage IV non-squamous non-small cell lung cancer (NSCLC).
Must not have certain genetic mutations that require specific treatments.
Must have measurable disease, meaning the cancer can be measured by doctors using specific criteria.
Must not have received previous treatment for advanced or metastatic NSCLC, except if certain conditions are met.
Must have a test result showing the level of a protein called PD-L1, which helps determine treatment options.
Must provide a tissue sample from a recent biopsy for research purposes.
Must be at least 18 years old.
Must have a life expectancy of at least 3 months, as assessed by the doctor.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures daily living abilities.
Must have adequate organ function, which includes specific blood, kidney, liver, and thyroid function levels.
Females who can have children must have a negative pregnancy test before starting the trial and agree to use effective birth control during the trial and for a specified time after.
Males with partners who can have children must agree to use effective birth control during the trial and for a specified time after.
Must be able to understand the trial’s purpose and agree to participate by signing a consent form.

Who Cannot Join the Study?

Patients with any other type of cancer besides metastatic non-squamous non-small cell lung cancer cannot participate.
Patients who have received any other experimental treatment for cancer in the last 4 weeks are not eligible.
Patients with severe heart problems, such as heart failure or recent heart attack, are excluded.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with active infections, including HIV, hepatitis B, or hepatitis C, are not allowed to participate.
Patients who are pregnant or breastfeeding are excluded from the study.
Patients with known allergies to the study medication or its ingredients cannot participate.
Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body, are not eligible.
Patients who have had a major surgery within the last 4 weeks are excluded.
Patients with a history of drug or alcohol abuse in the past 6 months cannot participate.

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 Del Mar	Barcelona	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
University Hospital St Marina Varna	Varna	Bulgaria
Hospital Universitario De Jaen	Jaen	Spain
MD Anderson Cancer Center	Madrid	Spain
LungenClinic Grosshansdorf GmbH	Grosshansdorf	Germany
Mbal Za Zhensko Zdrave Nadezhda OOD	Sofia	Bulgaria
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Med Polonia Sp. z o.o.	Poznan	Poland
Hospital Universitario Virgen Macarena	Sevilla	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Evangelisches Klinikum Bethel gGmbH	Bielefeld	Germany
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Oncomed S.R.L.	Timisoara	Romania
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
Srughtib Knncckpagab Bmazjuspc Fnue Doz Gyceolctvt Mxlyh	Moers	Germany
Cszawfv Poewndoi Sjbwlg	Sibiu	Romania
Ivlxgg Ikxndwcm Fkvdqgzipvrit Ornbazrrjxe	Rome	Italy
Hwinndfu Uxthjcxirfnye Mewxxku Db Vqnyfjfzwt	Santander	Spain
Hlgtalig Uxorehetfaomi Rzflxvsk De Maqqqh	Malaga	Spain
Hhyettwd Slc Pgyql	Logrono	Spain
Isktxvcv Rxbknglbv Paf Lk Sybsfs Dce Tvcdyr Diox Armuiup Iqvr Srzspw	Meldola	Italy
Upoqmjxlyqqohbbkxgbbv Wwmqcuxie Atm	Wuerzburg	Germany
Gkyg Mhuhgoq Svrzrz	Bucharest	Romania
Cefuwtx Ohcypelz Cthkin Bsmzwl Etty	Burgas	Bulgaria
Kipzndcc Eadcfpkkuncwhqpzuonsbcog Hnzzuahsbilfddxyf	Essen	Germany

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.07.2025
Germany	Recruiting	01.07.2025
Italy	Recruiting	01.07.2025
Poland	Recruiting	01.07.2025
Romania	Recruiting	01.07.2025
Spain	Recruiting	01.07.2025

Trial locations

Investigated drugs:

Visugromab is an experimental medication being tested in this clinical trial. It is designed to help the body’s immune system fight cancer cells more effectively. By targeting specific proteins on the surface of cancer cells, Visugromab aims to enhance the immune response against these cells, potentially slowing down or stopping the growth of the cancer.

Pembrolizumab is a type of immunotherapy that helps the immune system recognize and attack cancer cells. It works by blocking a specific protein that prevents the immune system from attacking the cancer, thereby allowing the immune system to better target and destroy cancer cells.

Pemetrexed is a chemotherapy drug used to treat certain types of lung cancer. It works by interfering with the cancer cells’ ability to grow and divide, which can help slow down or stop the progression of the cancer.

Carboplatin is another chemotherapy medication used in the treatment of lung cancer. It works by damaging the DNA of cancer cells, which prevents them from multiplying and can lead to their death. This helps to reduce the size of the tumor and slow the spread of the cancer.

Metastatic non-squamous non-small cell lung cancer – This is a type of lung cancer that begins in the tissues of the lung and is characterized by the absence of squamous cells. It is known for spreading beyond the lungs to other parts of the body, which is referred to as metastasis. The disease progresses as cancer cells grow and multiply, forming tumors that can invade nearby tissues and organs. Over time, these cancerous cells can enter the bloodstream or lymphatic system, facilitating further spread. The progression of the disease can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. As the cancer advances, it may affect the function of other organs, depending on where it has spread.

Trial ID:

2024-516792-32-01

Protocol code:

CTL-002-003

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Visugromab with Pembrolizumab, Pemetrexed, and Carboplatin for First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?