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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

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Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

9 criteria

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.
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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 trial?

4 criteria

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.

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Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland
Not recruiting
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
Vilnius, Lithuania

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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.

What is already known about the treatment

CT-P51
CT-P51 is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials to assess its effectiveness and safety compared to Keytruda, particularly in combination with chemotherapy for treating patients with a specific type of lung cancer that has spread and has not been treated before. The main therapeutic use of CT-P51 is for previously untreated metastatic non-squamous non-small cell lung cancer. At the molecular level, CT-P51 works by targeting and blocking certain proteins that help cancer cells evade the immune system, allowing the body's natural defenses to better attack the cancer. It is classified as an immunotherapy drug, which is a type of treatment that uses the body's immune system to fight cancer.
Keytruda
Keytruda is also administered as an intravenous infusion, similar to CT-P51, and is a well-established medication in the treatment of various cancers, including lung cancer. It is used for patients with previously untreated metastatic non-squamous non-small cell lung cancer, often in combination with chemotherapy. Keytruda works by inhibiting a protein called PD-1, which is found on the surface of immune cells and can be used by cancer cells to hide from the immune system. By blocking this protein, Keytruda helps the immune system recognize and attack cancer cells more effectively. It is classified as an immunotherapy drug, focusing on enhancing the body's immune response against cancer.

Investigated diseases

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.