Not recruiting

Study on Livmoniplimab and Budigalimab with Chemotherapy for Adults with Untreated Metastatic Non-Small Cell Lung Cancer

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 metastatic non-squamous non-small cell lung cancer (NSCLC), a type of lung cancer that has spread to other parts of the body. The study will compare two different treatment combinations. One group will receive a combination of livmoniplimab and budigalimab along with chemotherapy, while the other group will receive pembrolizumab with chemotherapy. Chemotherapy involves using drugs to kill cancer cells, and in this study, it includes medications like carboplatin, cisplatin, and pemetrexed.

The purpose of the study is to find the best dose and to evaluate the safety and effectiveness of these treatment combinations. Participants will be randomly assigned to one of the two groups. The study will be conducted in two stages. In the first stage, the focus will be on assessing the safety and activity of the treatments to determine the best dose for the second stage. The second stage will compare the effectiveness of the two treatment combinations in terms of overall survival, which means how long patients live after starting the treatment.

Participants will receive their assigned treatments through intravenous infusions, which means the medication will be given directly into a vein. The study will last for several months, and participants will be monitored regularly to check for any side effects and to see how well the treatment is working. The study aims to provide valuable information that could help improve treatment options for people with this type of lung cancer.

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
Initial treatment phase
The study begins with the administration of medications through an intravenous route. This involves the use of carboplatin, budigalimab, livmoniplimab, cisplatin, pembrolizumab, and pemetrexed. Each medication is provided as a solution for infusion.
The purpose of this phase is to assess the safety and activity of livmoniplimab and budigalimab in combination with chemotherapy. The goal is to determine the recommended dose for the next phase of the study.
Step 2
Evaluation of response
During this stage, the effectiveness of the treatment is evaluated. This involves measuring the best overall response, which includes complete or partial response to the treatment.
The primary focus is on progression-free survival, which refers to the length of time during and after the treatment that the patient lives with the disease without it getting worse.
Step 3
Dose determination
Based on the results from the initial treatment phase, the optimal dose of livmoniplimab is determined for the next stage of the study.
This involves selecting the recommended Phase 3 dose (RP3D) for livmoniplimab.
Step 4
Comparison phase
In this phase, the activity of the recommended dose of livmoniplimab and budigalimab in combination with chemotherapy is compared to pembrolizumab in combination with chemotherapy.
The main objective is to evaluate overall survival, which is the time from the start of the treatment until death from any cause.
Step 5
Ongoing assessment
Throughout the study, ongoing assessments are conducted to monitor the patient's response to the treatment.
These assessments include measuring changes in physical functioning and quality of life, as well as tracking any adverse events.

Who can join the trial?

7 criteria

The patient must have a confirmed diagnosis of **metastatic non-squamous non-small cell lung cancer (NSCLC)**. This means the cancer has spread to other parts of the body and is not of the squamous type.
The patient should not have specific genetic changes like **EGFR** or **ALK mutations** for which there is a targeted treatment available. These are specific changes in the cancer cells that can be treated with certain drugs.
The patient must have completed **palliative radiotherapy** more than 7 days before starting the study treatment. Palliative radiotherapy is a type of radiation treatment aimed at relieving symptoms rather than curing the disease.
The patient must have at least one **measurable lesion** as per specific criteria used to evaluate tumors. A lesion is an area of abnormal tissue, and measurable means it can be accurately measured to track changes.
The patient should have a **life expectancy** of at least 3 months and their organs should be functioning adequately.
The patient must have an **ECOG performance status** score of 0, 1, or 2. This score is used to assess how well a patient can perform daily activities, with 0 being fully active and 2 indicating some limitations.
Both **male and female** patients are eligible to participate.

Who cannot join the trial?

10 criteria

Patients who have already received treatment for their lung cancer cannot participate.
Patients with a different type of lung cancer than the one specified in the study are not eligible.
Patients with other serious health conditions that could interfere with the study treatment are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have had another type of cancer in the past, unless it was successfully treated and is not currently active, are not eligible.
Patients with known allergies to the study drugs or similar medications cannot participate.
Patients who are currently participating in another clinical trial are excluded.
Patients with a history of drug or alcohol abuse that could affect their ability to follow the study procedures are not eligible.
Patients with certain infections, such as HIV or hepatitis, are excluded from the study.
Patients who have had a major surgery or significant injury within a certain time frame before the study starts cannot participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
CHU Grenoble Alpes
La Tronche, France
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Livmoniplimab
is an experimental medication being tested for its safety and effectiveness in treating metastatic non-squamous non-small cell lung cancer. It is used in combination with other treatments to see if it can improve patient outcomes.
Budigalimab
is another investigational drug used alongside livmoniplimab and chemotherapy. The study aims to determine if this combination can enhance the treatment of lung cancer.
Pembrolizumab
is an established medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells. In this trial, it is combined with chemotherapy to compare its effectiveness against the new combination of livmoniplimab and budigalimab.
Platinum Doublet Chemotherapy
is a standard chemotherapy treatment for lung cancer. It involves using two chemotherapy drugs together to increase the effectiveness of the treatment. This therapy is used in combination with the other medications being tested in the trial.

What is already known about the treatment

Livmoniplimab
Livmoniplimab is administered intravenously and is currently being studied in clinical trials for its potential use in treating untreated metastatic non-squamous non-small cell lung cancer. It is in the experimental phase, with ongoing research to determine its optimal dose, safety, and efficacy. The medication works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells more effectively. It is classified as an immunotherapy agent, which is a type of treatment that uses the body's immune system to fight cancer.
Budigalimab
Budigalimab is given through intravenous infusion and is under investigation in clinical trials for its role in treating untreated metastatic non-squamous non-small cell lung cancer. It is still in the research phase, with studies focusing on its safety and effectiveness when used in combination with other treatments. Budigalimab functions by inhibiting certain immune checkpoints, thereby enhancing the immune system's ability to combat cancer cells. It falls under the category of monoclonal antibodies, which are laboratory-made molecules that can mimic the immune system's ability to fight off harmful pathogens.
Pembrolizumab
Pembrolizumab is administered via intravenous infusion and is an established treatment for various types of cancer, including untreated metastatic non-squamous non-small cell lung cancer. It is widely recognized in medical literature for its effectiveness in improving survival rates in cancer patients. Pembrolizumab works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system attack cancer cells more effectively. It is classified as a checkpoint inhibitor, a type of immunotherapy that helps the immune system recognize and destroy cancer cells.

Investigated diseases

Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the non-squamous cells of the lung and has spread to other parts of the body. It is characterized by the uncontrolled growth of abnormal cells in the lung tissue, which can form tumors. As the disease progresses, these cancerous cells can invade nearby tissues and organs, leading to metastasis. The spread of cancer cells to distant parts of the body can affect the function of vital organs. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower course.