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Study of Pembrolizumab and Lenvatinib for Patients with Resectable Non-Small-Cell Lung Cancer

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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 a type of lung cancer known as Non-Small-Cell Lung Cancer (NSCLC). The study is exploring the effects of a combination of two treatments: Pembrolizumab and Lenvatinib. Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer cells. Lenvatinib, with the code name MK-7902, is a type of medication called a tyrosine-kinase inhibitor, which works by blocking certain proteins that cancer cells need to grow.

The purpose of this study is to investigate how well these treatments work when given before and after surgery in patients with NSCLC that can be surgically removed. The study will involve patients receiving a combination of Pembrolizumab and Lenvatinib before surgery, known as neoadjuvant therapy, and then Pembrolizumab alone after surgery, known as adjuvant therapy. The study will last for several years, with regular check-ups to monitor the patients' health and the effectiveness of the treatment.

Participants in the study will receive the treatments through an intravenous infusion for Pembrolizumab and oral capsules for Lenvatinib. The study aims to see if this combination can lead to a significant reduction in cancer cells before surgery and improve long-term outcomes such as survival rates and disease-free periods after treatment. The study will also assess the safety and feasibility of using these treatments in this way.

The research process

The trial runs in 5 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, the participant will provide written informed consent.
Eligibility is confirmed based on criteria such as age, diagnosis of resectable non-small-cell lung cancer (NSCLC), and adequate organ function.
Step 2
Neoadjuvant therapy
The participant will receive a combination of pembrolizumab and lenvatinib as neoadjuvant therapy.
Pembrolizumab is administered as an intravenous infusion, which means it is given directly into a vein.
Lenvatinib is taken orally in the form of capsules.
Step 3
Surgical resection
After completing the neoadjuvant therapy, the participant will undergo surgical resection of the lung cancer.
Step 4
Adjuvant therapy
Following surgery, the participant will receive pembrolizumab as adjuvant therapy to help prevent cancer recurrence.
This involves additional intravenous infusions of pembrolizumab.
Step 5
Follow-up and monitoring
The participant will be monitored for disease-free survival and overall survival at intervals of 1, 2, 3, and 5 years.
Regular assessments will be conducted to evaluate the response to treatment and ensure safety.

Who can join the trial?

8 criteria

Participants must be **18 years or older**.
Must have a confirmed diagnosis of **Non-Small-Cell Lung Cancer (NSCLC)** that can be surgically removed, specifically stages **IA2 to IIIA**. This means the cancer is in an early to moderate stage.
The disease must be **measurable** according to specific medical guidelines called **RECIST 1.1**.
**Male participants** must agree to use **contraception** during the study and for at least 120 days after the last treatment dose. They should also avoid donating sperm during this time.
**Female participants** must not be pregnant or breastfeeding. They must either be unable to have children or agree to use contraception during the study and for at least 120 days after the last treatment dose.
Participants must provide **written informed consent**, which means they agree to join the study after understanding all the details.
Participants should have an **ECOG performance status** of **0 to 1**, which indicates they are fully active or have some symptoms but can still carry out light work.
Participants must have **adequate organ function**, meaning their organs are working well enough to handle the study treatment. Tests to confirm this must be done within 14 days before starting the study treatment.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer other than Non-Small-Cell Lung Cancer cannot participate. This type of cancer affects the lungs and is not the same as other lung cancers.
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, which means they might need special protection or care, cannot participate.
Patients who do not meet the health requirements for the study cannot participate. This means their overall health condition must fit the study's needs.

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Verified sites

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Medizinische Universitaet Innsbruck
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Innsbruck, Austria

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Investigated drugs

Pembrolizumab
is a medication used in this trial to help the body's immune system fight cancer cells. It works by blocking a specific protein on the surface of immune cells, which allows these cells to better detect and attack cancer cells. In this trial, Pembrolizumab is used both before and after surgery to treat non-small-cell lung cancer.
Lenvatinib
is another medication used in this trial, which helps to stop the growth of cancer cells by blocking certain proteins that cancer cells need to grow. It is used in combination with Pembrolizumab before surgery to enhance the treatment's effectiveness against non-small-cell lung cancer.

What is already known about the treatment

Pembrolizumab
Pembrolizumab is administered intravenously, typically as an infusion over a set period. It is currently well-established in medical literature as an immunotherapy for various cancers, including non-small-cell lung cancer (NSCLC). The main therapeutic indication for Pembrolizumab is to enhance the body's immune response against cancer cells. At the molecular level, it works by blocking the PD-1 pathway, which cancer cells use to evade the immune system. Pembrolizumab is classified as a monoclonal antibody.
Lenvatinib
Lenvatinib is taken orally in the form of capsules. It is recognized in medical literature as a treatment for certain types of cancer, including NSCLC, when used in combination with other therapies. The primary therapeutic indication for Lenvatinib is to inhibit tumor growth and spread. Its mechanism of action involves blocking specific proteins called tyrosine kinases, which are involved in the growth of cancer cells. Lenvatinib is classified as a tyrosine kinase inhibitor.

Investigated diseases

Non-Small-Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. Early stages may not show significant symptoms, making it challenging to detect without medical screening.