Recruiting

Study on Treating Advanced Non-Small Cell Lung Cancer with Cemiplimab and Chemotherapy Based on Blood Tumor DNA Levels

Verified siteRegistered drug

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 the treatment of patients with non-small cell lung cancer (NSCLC), a type of lung cancer that is common and can spread to other parts of the body. The study will use a medication called Cemiplimab, which is a type of therapy that helps the immune system fight cancer. In some cases, Cemiplimab will be combined with chemotherapy, which is a treatment that uses drugs to kill cancer cells.

The purpose of the study is to see if using Cemiplimab alone or with chemotherapy, based on the levels of tumor DNA circulating in the blood, can improve the survival of patients with advanced NSCLC. The study will start with patients receiving Cemiplimab alone. After two cycles, the treatment plan may change depending on the levels of tumor DNA in the blood. Some patients may continue with Cemiplimab alone, while others may receive additional chemotherapy.

Participants in the study will receive their treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of time, and the progress of the patients will be monitored to see how well the treatment works and to check for any side effects. The goal is to find out if this approach can help patients live longer and improve their quality of life.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Upon joining the study, you will begin with the **cemiplimab** treatment. This medication is administered through an intravenous infusion, which means it is given directly into your vein. The dosage and frequency will be determined by the medical team based on your specific needs.
This phase involves receiving **cemiplimab** alone for two cycles. Each cycle typically lasts for a few weeks, during which you will have regular appointments to receive the medication and monitor your health.
Step 2
Evaluation of treatment response
After completing two cycles of **cemiplimab**, your response to the treatment will be evaluated. This involves checking the levels of circulating tumor DNA (ctDNA) in your blood. ctDNA is a marker that helps assess how well the treatment is working.
Based on the ctDNA levels, the medical team will decide the next steps in your treatment plan. This evaluation is crucial to determine whether additional treatments are needed.
Step 3
Subsequent treatment phase
Depending on the results of the ctDNA evaluation, you may continue with **cemiplimab** alone or receive a combination of **cemiplimab** and chemotherapy. The chemotherapy may include medications such as **pemetrexed**, **carboplatin**, and **paclitaxel**. These are also administered through intravenous infusion.
The specific combination and schedule of these medications will be tailored to your condition and response to the initial treatment phase. Regular monitoring and follow-up appointments will be scheduled to ensure the effectiveness and safety of the treatment.
Step 4
Ongoing monitoring and follow-up
Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to track the progress of the treatment.
The medical team will provide guidance and support, addressing any side effects or concerns that may arise during the trial. It is important to attend all scheduled appointments and communicate any changes in your health to the medical staff.

Who can join the trial?

14 criteria

You must have been diagnosed with non-small cell lung cancer (NSCLC) at stage IV or stage IIIB/C, and you are not a candidate for surgery or combined chemotherapy and radiotherapy.
Your cancer must not have been treated with any systemic anti-cancer therapy before.
Your PD-L1 level must be 50% or higher. PD-L1 is a protein that can affect how your immune system responds to cancer.
Your ECOG performance status must be 0-1. This is a scale that measures your daily living abilities, where 0 means fully active and 1 means some symptoms but nearly fully active.
You must be 18 years of age or older.
If you had chemotherapy or radiotherapy for locally advanced disease, it must have been completed at least 6 months before joining the study.
If you had chemotherapy before or after surgery for early-stage cancer, it must have been completed at least 6 months before joining the study.
You must have at least one measurable tumor that can be seen on a CT scan, which is a detailed imaging test.
You must be expected to live for more than 12 weeks.
Your blood, liver, and kidney functions must be within normal ranges.
You must agree to participate in the study and provide your consent as required by local regulations.
You must be available for treatment and follow-up visits.
If you are a woman who can become pregnant, you must have a negative pregnancy test within 3 days before joining the study.
If you are sexually active and can have children, you must use a highly effective birth control method during the study and for at least 5 months after the last dose of the study drug if you are female, and 7 months if you are male.

Who cannot join the trial?

3 criteria

Patients with any other type of cancer besides Non-small cell lung cancer (NSCLC) cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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
El Hospital Universitario De Gran Canaria Dr. Negrin
Las Palmas De Gran Canaria, Spain
Verified
Hospital Clinico San Carlos
Madrid, Spain
Verified
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain

Trial locations

Where you can join this trial

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

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

Cemiplimab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, patients with advanced non-small cell lung cancer (NSCLC) receive cemiplimab to see if it can help control the cancer. The study is also looking at whether adding chemotherapy to cemiplimab treatment, based on certain test results, can improve how long patients live.

What is already known about the treatment

Cemiplimab – Cemiplimab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced non-small cell lung cancer (NSCLC). The main therapeutic use of cemiplimab is to help the immune system fight cancer cells. At the molecular level, cemiplimab works by blocking a protein called PD-1 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 drug that helps the body's immune system target and destroy cancer cells.

Investigated diseases

Non-small cell lung cancer (NSCLC) – Non-small cell lung cancer is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can form tumors and may spread to other parts of the body, a process known as metastasis. The progression of NSCLC can vary, with some tumors growing slowly and others more rapidly. Symptoms often include persistent cough, chest pain, and difficulty breathing, which may worsen as the disease advances. The disease is more common in smokers, but it can also occur in non-smokers.