Not recruiting

Study of Pembrolizumab, Favezelimab, and Lenvatinib 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 Stage IV non-small cell lung cancer, a type of advanced lung cancer. The study involves a combination of medications, including pembrolizumab (also known as MK-3475), favezelimab (MK-4280), lenvatinib (MK-7902), and quavonlimab (MK-1308). These medications are being tested to see how well they work together in treating this type of cancer. Some of these medications are given as a solution through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein, while others are taken orally in capsule form.

The purpose of the study is to evaluate the effectiveness of these medication combinations in treating advanced non-small cell lung cancer. Participants in the study will receive one or more of these medications, and some may receive a placebo. The study will monitor how the cancer responds to the treatment over time. The trial will last for a period of up to 24 months, during which participants will have regular check-ups and assessments to track their progress and any side effects they may experience.

This study aims to provide valuable information on how these medication combinations can help manage advanced non-small cell lung cancer. By participating, individuals contribute to research that may improve treatment options for this disease in the future. The study will also collect data on the safety of these treatments and how they affect the overall health and well-being of 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
Joining the study
Upon joining the study, a diagnosis of Stage IV non-small cell lung cancer is confirmed.
Eligibility is determined based on specific criteria, including the absence of certain genetic mutations and adequate organ function.
Step 2
Treatment initiation
Treatment begins with the administration of pembrolizumab through an intravenous infusion. This medication is part of a combination therapy aimed at treating advanced lung cancer.
Step 3
Combination therapy
The treatment includes additional medications such as favezelimab and quavonlimab, both administered via intravenous infusion.
Oral medication lenvatinib is also part of the regimen, taken in capsule form.
Step 4
Treatment monitoring
Throughout the study, the response to treatment is monitored using specific criteria to evaluate the effectiveness of the therapy.
Regular assessments are conducted to track progression-free survival and overall survival.
Step 5
Adverse event monitoring
Participants are monitored for any adverse events that may occur during the study.
The occurrence of adverse events and any resulting discontinuation of the study drug are documented.
Step 6
Study completion
The study is estimated to conclude by June 28, 2025.
Final evaluations are conducted to assess the overall outcomes of the treatment.

Who can join the trial?

9 criteria

The patient must have a confirmed diagnosis of **Stage IV non-small cell lung cancer**. This means the cancer is advanced and has spread to other parts of the body.
The patient must not have had any previous treatments for advanced cancer.
The patient must have confirmation that certain targeted therapies are not suitable as the main treatment. This includes therapies for specific genetic changes in the cancer, such as **EGFR**, **ALK**, **ROS1**, or **B-Raf** mutations.
The patient must have a tumor that can be measured by the doctor using specific guidelines called **RECIST 1.1**.
Male participants must agree to use birth control during the study and for at least 120 days after the last treatment dose. They must also agree not to donate sperm during this time. If their partner is pregnant, they must use a condom.
Female participants can join if they are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use birth control during the study and for at least 120 days after the last treatment dose.
The patient must provide a sample of their tumor tissue, either from a previous biopsy or a new one, as long as it hasn't been treated with radiation before.
The patient must have a good level of daily functioning, as measured by a scale called the **ECOG performance status**, with a score of 0 or 1. This means they are fully active or have some symptoms but can still do light work.
The patient must have organs that are working well enough to handle the treatment.

Who cannot join the trial?

3 criteria

Patients with a different type of cancer than Stage IV non-small cell lung cancer cannot participate. This is a specific type of lung cancer that has spread to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.

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Verified sites

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

Verified
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Wroclaw, Poland
Verified
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Verified
Hospital Universitario 12 De Octubre
Madrid, Spain

Trial locations

Where you can join this trial

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Investigated drugs

Pembrolizumab: This medication is used in the trial as a part of combination therapy for advanced non-small cell lung cancer. It is an immunotherapy drug that helps the immune system recognize and attack cancer cells. Pembrolizumab is often used to treat various types of cancer by blocking a specific protein that prevents the immune system from attacking cancer cells.

What is already known about the treatment

Pembrolizumab – This medication is administered intravenously, meaning it is given directly into a vein. It is currently well-established in medical literature and is used in the treatment of various cancers, including advanced non-small cell lung cancer. Pembrolizumab works by blocking a specific protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Stage IV Non-Small Cell Lung Cancer – This is an advanced form of lung cancer where the disease has spread beyond the lungs to other parts of the body. It typically originates in the tissues of the lungs and is characterized by uncontrolled cell growth. As the cancer progresses, it can invade nearby tissues and organs, leading to a range of symptoms such as persistent cough, chest pain, and difficulty breathing. The spread of cancer cells to distant organs, known as metastasis, is a hallmark of Stage IV. This stage is often associated with significant impact on the patient's quality of life due to the widespread nature of the disease.