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Study to Compare Fianlimab and Cemiplimab Combination with Cemiplimab Alone for Adults with Advanced 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 treatments for Advanced Non-Small Cell Lung Cancer (NSCLC), a type of lung cancer that has spread beyond the lungs and is not suitable for surgery or certain types of radiation therapy. The study is investigating the effectiveness of a combination of two medications, Fianlimab and Cemiplimab, compared to Cemiplimab alone. Fianlimab is a new treatment being tested, while Cemiplimab is already used to treat certain cancers. The purpose of the study is to determine if the combination of these two medications is more effective than using Cemiplimab by itself.

Participants in the study will receive either the combination of Fianlimab and Cemiplimab or Cemiplimab alone. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving which treatment, to ensure unbiased results. Some participants may receive a placebo, which looks like the treatment but does not contain the active medication. The study will monitor how well the cancer responds to the treatments and how long participants live after starting the treatment.

The trial will also track any side effects or adverse events that occur during the study. Participants will be regularly assessed through medical check-ups and imaging tests like MRI or computed tomography (CT) scans to evaluate the progress of the treatment. The study aims to provide valuable information on the potential benefits and risks of using Fianlimab in combination with Cemiplimab for treating advanced NSCLC.

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, eligibility is confirmed based on specific criteria, including the type and stage of lung cancer and previous treatments.
A sample of tumor tissue is required for analysis to determine the presence of certain proteins.
Step 2
Initial assessment
An initial assessment is conducted to evaluate overall health and organ function.
Imaging tests such as CT or MRI scans are performed to identify measurable lesions.
Step 3
Treatment assignment
Participants are randomly assigned to receive either a combination of fianlimab and cemiplimab or cemiplimab alone.
The study is double-blind, meaning neither the participants nor the researchers know which treatment is being administered.
Step 4
Treatment administration
Cemiplimab is administered as a 350 mg solution for infusion through a vein.
Fianlimab is also administered intravenously as a solution for injection.
The frequency and duration of the treatment are determined by the study protocol.
Step 5
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and any side effects.
Participants undergo periodic imaging tests to evaluate changes in tumor size and progression.
Step 6
Completion of treatment
The treatment phase continues until the study's end date or until specific criteria for discontinuation are met.
Participants may continue to be monitored for overall survival and quality of life measures.

Who can join the trial?

10 criteria

Patients must have a type of lung cancer called Advanced Non-Small Cell Lung Cancer (NSCLC), which can be either non-squamous or squamous.
The cancer must be at stage IIIB, IIIC, or stage IV, meaning it is advanced and cannot be treated with surgery or certain types of radiation therapy.
Patients should not have received any previous treatment for their cancer if it has come back or spread to other parts of the body.
A sample of the tumor tissue must be available for testing, and no treatment should have been given between the time the sample was taken and the start of the study.
For phase 2 of the study, patients need to have a specific protein called PD-L1 present in at least 50% of their tumor cells. This will be checked by a certified laboratory.
For phase 3, the presence of the PD-L1 protein in at least 50% of tumor cells will be confirmed by a central laboratory.
Patients must have at least one tumor that can be measured using imaging tests like a CT scan or MRI.
The patient's overall health should be good enough to participate, as measured by a scale called the Eastern Cooperative Oncology Group (ECOG) performance status, which should be 0 or 1. This means the patient is fully active or has some symptoms but can still do light work.
Patients must have organs and bone marrow that are working well enough to handle the treatment.
There may be other specific requirements that are part of the study protocol.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer other than Advanced Non-Small Cell Lung Cancer.
Patients whose tumors do not express PD-L1 in at least 50% of tumor cells. PD-L1 is a protein that can be found on the surface of cells.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population that the study is not designed to include.

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Verified sites

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

Alexandra Hospital
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Athens, Greece
Athens Medical Center S.A.
Verified
Thessaloniki, Greece
Centre Hospitalier Regional D'Angers
Verified
Angers, France

Trial locations

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Investigated drugs

Fianlimab
Fianlimab is an experimental medication being studied for its potential to help the immune system fight cancer. It works by targeting a protein called LAG-3, which can slow down the immune response. By blocking this protein, fianlimab may help the immune system better recognize and attack cancer cells. In this trial, it is being tested in combination with another medication to see if it can improve treatment outcomes for patients with advanced non-small cell lung cancer.
Cemiplimab
Cemiplimab is a medication that helps the immune system fight cancer by targeting a protein called PD-1. This protein can prevent the immune system from attacking cancer cells. By blocking PD-1, cemiplimab may enhance the body's ability to detect and destroy cancer cells. In this trial, cemiplimab is being used both alone and in combination with fianlimab to treat patients with advanced non-small cell lung cancer.

What is already known about the treatment

Fianlimab
Fianlimab is administered intravenously and is currently being studied in clinical trials for its potential use in treating advanced non-small cell lung cancer. It is an experimental medication, not yet widely recognized in medical literature. The main therapeutic indication is for patients with tumors expressing PD-L1 in 50% or more of tumor cells. Fianlimab works by targeting the LAG-3 protein, which helps regulate immune responses, potentially enhancing the body's ability to fight cancer. It is classified as an anti-LAG-3 antibody.
Cemiplimab
Cemiplimab is given through intravenous infusion and is approved for use in certain types of cancer, including advanced non-small cell lung cancer. It is well-documented in medical literature and is used primarily for tumors with high PD-L1 expression. The medication functions by blocking the PD-1 protein on immune cells, thereby boosting the immune system's ability to attack cancer cells. Cemiplimab is classified as an anti-PD-1 antibody.

Investigated diseases

Advanced Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its relatively slow growth compared to small cell lung cancer. It is termed "advanced" when it has spread beyond the lungs to other parts of the body. The disease often progresses through stages, starting from localized tumors to more widespread metastasis. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the cancer advances, it can lead to more severe respiratory issues and general health decline. The progression can vary significantly among individuals, influenced by factors such as the specific subtype of the cancer and overall health.