Study Comparing Effects and Safety of CT-P51 and Pembrolizumab with Drug Combination in Patients with Untreated Metastatic Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying the effects and safety of two medications, CT-P51 and Keytruda, in combination with chemotherapy for patients with a type of lung cancer known as metastatic non-squamous non-small cell lung cancer. This type of cancer is characterized by its spread beyond the lungs and is not of the squamous cell type. The chemotherapy used in this study includes drugs like pemetrexed, carboplatin, and cisplatin, which are administered as solutions through an intravenous infusion, meaning they are given directly into the bloodstream.

The purpose of the study is to compare the effectiveness of CT-P51 and Keytruda when used alongside the chemotherapy regimen. Participants in the study will receive either CT-P51 or Keytruda along with the chemotherapy drugs. The study will be conducted over several cycles, with each cycle lasting a few weeks. During these cycles, the response to the treatment will be monitored to determine how well the cancer responds to the therapy.

Throughout the study, participants will be closely monitored for any side effects or changes in their condition. The study aims to provide valuable information on the safety and effectiveness of these treatments in managing this specific type of lung cancer. By the end of the study, researchers hope to determine if CT-P51 and Keytruda are equally effective in treating patients with this condition.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the details.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes a review of your medical history, a physical examination, and various tests to ensure you meet the study criteria.

3 treatment cycle 1

You will begin the first treatment cycle. This involves receiving medications through an intravenous infusion. The medications include pemetrexed, pembrolizumab, and either carboplatin or cisplatin. The specific dosage and frequency will be determined by the study protocol.

4 subsequent treatment cycles

You will continue to receive treatment in cycles. Each cycle typically lasts a few weeks, during which you will receive the same medications as in the first cycle. The total number of cycles will be determined by the study protocol.

5 regular monitoring

Throughout the trial, regular monitoring will be conducted. This includes physical exams, blood tests, and imaging studies to assess your response to the treatment and monitor for any side effects.

6 end of treatment

At the end of the treatment period, a final assessment will be conducted. This includes a comprehensive evaluation of your health and the effectiveness of the treatment.

7 follow-up

After completing the treatment, follow-up visits will be scheduled to monitor your long-term health and any lasting effects of the treatment.

Who Can Join the Study?

Must be a male or female who is 18 years or older.
Must have Stage IV non-squamous non-small cell lung cancer (NSCLC).
Must have a negative result for both EGFR mutation and ALK rearrangement. If you have certain other genetic changes like ROS1 rearrangement, MET exon 14 skipping, RET rearrangement, or BRAF V600E mutation, you may be excluded if specific treatments are recommended by local guidelines.
Must have a tumor sample that has not been treated with radiation before the biopsy. This sample should be suitable for a test called PD-L1 assessment and should be taken within 6 months before joining the study.
Must not have received any previous systemic anticancer therapy for metastatic non-squamous NSCLC. However, if you had treatment before and it was completed at least 12 months before the cancer spread, you may still be eligible.
Must have at least one measurable lesion according to specific criteria (RECIST version 1.1). This means:
- Tumor lesions should be at least 10 mm in size as seen on a CT scan.
- Malignant lymph nodes should be at least 15 mm in size as seen on a CT scan.
Must have an ECOG Performance score of 1 or less. This score measures your ability to perform daily activities. You should also have a life expectancy of at least 3 months.
Must have adequate organ function. This means your organs are working well enough to participate in the study.

Who Cannot Join the Study?

Patients who have already received treatment for their lung cancer cannot participate.
Patients with a type of lung cancer that is not non-squamous non-small cell lung cancer cannot participate. Non-squamous means the cancer cells do not have a flat shape, and non-small cell refers to a group of lung cancers that behave similarly.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, 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
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Klinički bolnički centar Zagreb (University Hospital Center Zagreb)	Zagreb	Croatia
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu	Wroclaw	Poland
Hospital Clinico San Carlos	Madrid	Spain
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk	Lublin	Poland

Other Sites

Site Name	City	Country
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Oncolab S.R.L.	Craiova	Romania
Hospital La Milagrosa S.A.	Madrid	Spain
Hospital Quironsalud Malaga	Malaga	Spain
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego	Walbrzych	Poland
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A	Cholargos	Greece
Virgen del Rocío University Hospital	Sevilla	Spain
Oncomed S.R.L.	Timisoara	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Szpital Specjalistyczny W Prabutach Sp. z o.o.	Prabuty	Poland
Vilnius University Hospital	Vilnius	Lithuania
Pula General Hospital Ospedale Generale di Pola	Pula	Croatia
Tkmhtivfrh Cnvren Hpjgzmwl	Thessaloniki	Greece
Lahnr Gdxjnut Humxcvic Of Avjeyu	Athens	Greece
Nfcmudgw Ipqfxcxw Osgqcvbxc Ipz Mdgwl Ssatfwqobkylnlltdlnlvevttdfk Ihiyulua Bnwftghq	Cracow	Poland
Hstyouhh Dn Lt Sybrn Csxv I Seaj Pea	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Croatia	Not yet recruiting	27.11.2024
Greece	Not yet recruiting	27.11.2024
Lithuania	Not yet recruiting	27.11.2024
Poland	Not yet recruiting	27.11.2024
Romania	Not yet recruiting	27.11.2024
Spain	Recruiting	27.11.2024

Trial locations

Investigated drugs:

CT-P51 is a medication being tested in this clinical trial. It is designed to work with other cancer treatments to help the body’s immune system fight cancer cells more effectively. The goal of using CT-P51 is to see if it can help improve the response to treatment in patients with a specific type of lung cancer.

Keytruda is a well-known cancer medication that helps the immune system detect and fight cancer cells. It is often used in combination with other treatments to enhance its effectiveness. In this trial, Keytruda is being compared to CT-P51 to see if they work equally well when used with other chemotherapy drugs.

Platinum-Pemetrexed Chemotherapy is a combination of two chemotherapy drugs used to treat certain types of lung cancer. These drugs work by stopping cancer cells from growing and dividing. In this trial, they are used alongside either CT-P51 or Keytruda to see how well the combination works in treating lung cancer.

Investigated diseases:

Non-small cell lung cancer

Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer – This type of lung cancer originates in the epithelial cells of the lung and is characterized by the absence of squamous cells. It is classified as non-small cell, which means the cancer cells are larger than those found in small cell lung cancer. The term “metastatic” indicates that the cancer has spread from the lungs to other parts of the body. As the disease progresses, it can invade nearby tissues and organs, leading to a variety of symptoms depending on the areas affected. The progression is often marked by the growth of tumors and the potential for further spread to distant organs. This type of cancer is typically diagnosed at an advanced stage due to its metastatic nature.

Trial ID:

2024-514048-98-00

Protocol code:

CT-P51 3.1

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Effects and Safety of CT-P51 and Pembrolizumab with Drug Combination in Patients with Untreated Metastatic Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?