Not recruiting

Study of Pembrolizumab with Drug Combination for Patients with Advanced Non-Small Cell Lung Cancer

Verified siteRegistered drugNo placebo

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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 treatments for advanced non-small cell lung cancer (NSCLC), a type of lung cancer. The study involves several investigational medications, including pembrolizumab, rolistobart (also known as MK-0482), boserolimab (MK-5890), vibostolimab (MK-7684), and MK-4830. These medications are being tested in combination with chemotherapy drugs such as paclitaxel, carboplatin, and pemetrexed disodium. The purpose of the study is to evaluate the effectiveness of these treatments in patients who have not received prior systemic treatment for their metastatic NSCLC.

Participants in the study will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will follow a structured plan where patients will receive the treatment over a period of time, with regular monitoring to assess how well the treatment is working and to check for any side effects. The study aims to understand how these investigational agents, when used with pembrolizumab and chemotherapy, can help in treating advanced NSCLC.

The trial will also look at the overall response of the cancer to the treatment, using criteria known as the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This will help determine the objective response rate, which is a measure of how much the cancer shrinks or disappears after treatment. Additionally, the study will monitor the progression-free survival, which is the length of time during and after treatment that the patient lives with the disease without it getting worse, and any adverse events or side effects experienced by participants.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, the first step involves an initial visit to the clinical trial site. During this visit, a healthcare professional will explain the study procedures and answer any questions.
A physical examination will be conducted, and blood samples may be taken to assess overall health and organ function.
Step 2
Treatment initiation
The treatment phase begins with the administration of medications through an intravenous infusion. This means the medication is given directly into a vein using a needle.
The medications used in this study include pembrolizumab, paclitaxel, carboplatin, and pemetrexed. The specific combination and dosage will be determined by the study protocol.
Step 3
Treatment schedule
The treatment is administered on a regular schedule, which may involve visits every few weeks. The exact frequency and duration will be explained by the healthcare team.
Each treatment session involves receiving the medication through an intravenous infusion, which may take several hours.
Step 4
Monitoring and assessments
Throughout the study, regular monitoring and assessments will be conducted to evaluate the response to treatment and any side effects.
This may include imaging tests, such as CT scans, to measure the size of the tumor and blood tests to monitor health.
Step 5
Follow-up visits
After completing the treatment phase, follow-up visits will be scheduled to continue monitoring health and any long-term effects of the treatment.
These visits may occur at regular intervals and involve similar assessments as during the treatment phase.
Step 6
End of study
The study concludes after the final follow-up visit. At this point, the healthcare team will discuss the overall findings and any next steps.
Participants may be provided with information about their treatment and any recommendations for future care.

Who can join the trial?

8 criteria

Must have a confirmed diagnosis of Stage IV squamous or nonsquamous non-small cell lung cancer (NSCLC). This means the cancer is in an advanced stage and has spread to other parts of the body.
If you have nonsquamous NSCLC, you should not be eligible for an approved targeted therapy. Targeted therapy is a type of treatment that uses drugs to target specific cancer cells.
Must be able to provide a sample of tumor tissue. This can be an old sample taken within the last 5 years, a sample taken after your last treatment but before the study screening, or a new sample taken within 90 days before starting the study treatment. The sample should not be from a tumor that has been treated with radiation.
Must not have received any previous systemic treatment for metastatic NSCLC. Systemic treatment refers to medication that travels through the bloodstream to reach cancer cells all over the body.
Must be able to complete all screening procedures within a 35-day period before starting the study.
Must have adequate organ function within 10 days before starting the study treatment. This means your organs, like your liver and kidneys, are working well enough to handle the treatment.
Male participants must agree to use contraception and should not donate sperm during the treatment and for at least 120 days after the last dose of pembrolizumab, and for at least 180 days after the last dose of chemotherapy.
Female participants must not be pregnant or breastfeeding. They must either not be of childbearing potential or agree to use contraception during the treatment and for at least 120 days after the last dose of pembrolizumab, and for at least 180 days after the last dose of chemotherapy.

Who cannot join the trial?

3 criteria

Patients with any other type of cancer besides non-small cell lung cancer cannot participate.
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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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Verified
Rome, Italy
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Verified
Gyor, Hungary

Trial locations

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Investigated drugs

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, pembrolizumab is used in combination with chemotherapy to treat patients with advanced non-small cell lung cancer who have not received treatment before. The goal is to see if this combination can help shrink the tumors or slow their growth.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently being studied in combination with chemotherapy for its effectiveness in treating advanced non-small cell lung cancer, a type of lung cancer. The main therapeutic use of pembrolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a specific protein called PD-1 on immune cells, which helps the immune system to better detect and fight cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps boost the body's natural defenses against cancer.

Investigated diseases

Non-Small Cell Lung Cancer – Non-small cell lung cancer is a type of lung cancer that begins in the tissues of the lungs. It is the most common form of lung cancer, accounting for a majority of cases. The disease progresses as cancer cells grow and form tumors, which can spread to other parts of the body. As the cancer advances, it may invade nearby tissues and organs, leading to further complications. The progression of non-small cell lung cancer can vary, with some tumors growing slowly while others may spread more rapidly. The disease is often categorized into stages based on the size of the tumor and the extent of its spread.