Study on the Effectiveness of Cemiplimab and Drug Combination for Patients with Oligometastatic Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for non-small cell lung cancer (NSCLC), specifically a type called synchronous oligometastatic NSCLC. This condition involves having a limited number of cancerous lesions that have spread from the original lung tumor to other parts of the body. The study aims to explore the benefits of adding a treatment called radical local treatment (RLT) to the standard care, which is based on immunotherapy. Immunotherapy is a type of cancer treatment that helps the immune system fight cancer. The trial will include several medications, such as Carboplatin, Paclitaxel, Cisplatin, Pemetrexed, Ipilimumab (also known as BMS734016), Cemiplimab (also known as REGN2810), Atezolizumab (also known as RO5541267), Pembrolizumab (also known as Lambrolizumab), and Nivolumab (also known as BMS936558). These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to determine if adding RLT to the standard immunotherapy-based care can improve the survival of patients with this type of lung cancer. Participants in the study will receive either the standard care alone or the standard care combined with RLT. The study will monitor the overall survival of the participants, which means the length of time they live after starting the treatment. Other aspects, such as the progression of the cancer, the type of relapses, and the quality of life, will also be observed. The study will last for a certain period, during which participants will undergo regular check-ups and treatments as part of the trial.

This trial is designed to provide valuable information on the effectiveness of combining RLT with immunotherapy for treating oligometastatic NSCLC. By participating in this study, researchers hope to find better ways to manage and treat this type of lung cancer, potentially leading to improved outcomes for patients in the future. The study will be conducted in a structured manner, ensuring that all participants receive the necessary care and monitoring throughout the trial period.

1 enrollment

Upon joining the study, the patient will be required to sign an informed consent form. This document confirms understanding and agreement to participate in the trial.

Eligibility is confirmed based on specific criteria, including a diagnosis of advanced synchronous oligometastatic non-small cell lung cancer (NSCLC) and a maximum of five metastases in three organs.

2 initial assessment

The patient undergoes a series of assessments to establish baseline health status. This includes imaging tests like CT scans and MRIs to evaluate the extent of cancer spread.

Blood tests and other evaluations are conducted to ensure the patient has acceptable organ function for the treatments planned.

3 treatment initiation

The patient begins receiving first-line immunotherapy-based standard of care (SoC) treatments. This may include medications such as carboplatin, ipilimumab, paclitaxel, cemiplimab, atezolizumab, pemetrexed, cisplatin, pembrolizumab, and nivolumab.

These medications are administered through intravenous infusion, with dosages and frequency determined by the healthcare team based on individual patient needs.

4 local ablative treatment

If eligible, the patient may receive radical local treatment (RLT) targeting up to five secondary lesions. This treatment aims to improve survival by addressing specific cancer sites.

The decision for RLT is made by a local multidisciplinary board, considering factors like lesion size and location.

5 ongoing monitoring

Throughout the trial, the patient attends regular follow-up visits to monitor treatment effects and overall health. This includes repeated imaging and blood tests.

The healthcare team assesses the patient’s response to treatment and adjusts the plan as necessary.

6 completion and follow-up

Upon completing the treatment phase, the patient continues to be monitored for any long-term effects or recurrence of cancer.

Follow-up care includes regular health assessments and support to manage any side effects experienced during the trial.

Who Can Join the Study?

The patient must have a type of lung cancer called advanced synchronous oligometastatic stage IV non-small cell lung cancer (NSCLC), which means the cancer has spread to a few other places in the body.
The patient must be able to understand, sign, and date a consent form written in French before any study-related procedures are done.
If the patient is a woman who can have children or a man, they must agree to use effective birth control during the study and for 6 months after finishing treatment.
The patient must be part of the social security system.
The patient must be willing and able to follow the study rules, including attending treatment sessions, scheduled visits, and examinations, as well as follow-up appointments.
The patient must be older than 18 years.
The patient must be eligible for first-line immunotherapy-based standard care according to European guidelines, and their PDL1 status must be available. PDL1 is a protein that can affect how the immune system responds to cancer.
The cancer spread, or metastases, must be suitable for a treatment called radical local treatment (RLT), with each metastasis being 5 cm or smaller on a CT scan, not including the main tumor.
The patient can have a maximum of 5 metastases in up to 3 different organs, as determined by specific imaging tests like brain MRI and FDG-PET.
If the patient has painful or urgent symptoms that need immediate radiation treatment, this is allowed before being assigned to a treatment group. These treated areas will be counted in the total number of metastases at the start of the study.
If the patient needs treatment for brain metastases, such as surgery or a type of radiation called SBRT, this is allowed. The brain metastases will be included in the total count of 5 lesions. The patient will then be assigned to treatment for cancer outside the brain.
The patient must have acceptable organ function to receive RLT.
The patient must have an ECOG performance status of 0-1, which is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.

Who Cannot Join the Study?

Patients with more than 5 secondary lesions cannot participate. A lesion is an area of abnormal tissue.
Patients who are not receiving standard care-based immunotherapy are excluded. Immunotherapy is a treatment that helps the body’s immune system fight cancer.
Patients with a different type of lung cancer than non-small cell lung cancer (NSCLC) are not eligible. NSCLC is a common type of lung cancer.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which may include those with certain health conditions or social situations, are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Institut Sainte Catherine	Avignon	France
Centre Henri Becquerel	Rouen	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Ipgxbksq dz Cqobskfcaqbm dw Gkuc	Nimes	France
Gdaxty Hpbgplshfkm Pblzwy Dc Sxx Db L Osyl	Creil	France
Gnrbka Heikdoqcwzm Ullllewuirvzb Pzfmt Pgfqxxigqvz Eg Nevisdfydabz	Paris	France
Cwydjb Okjaj Lvnhfkv	Lille	France
Iejfsylg Cavqh	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.11.2024

Trial locations

Investigated drugs:

Immunotherapy: This treatment helps the body’s immune system to fight cancer. It uses substances made by the body or in a laboratory to improve or restore immune system function. In this trial, immunotherapy is part of the standard care for patients with non-small cell lung cancer.

Radical Local Treatment (RLT): This therapy involves targeting and treating up to five secondary cancer lesions directly. The goal is to eliminate these lesions to improve the patient’s overall survival. This treatment is used in combination with standard immunotherapy to enhance its effectiveness.

Investigated diseases:

Non-small cell lung cancer

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. NSCLC is known for its slower progression compared to small cell lung cancer. The disease can spread to other parts of the body, a process known as metastasis. In the case of synchronous oligometastatic NSCLC, the cancer has spread to a limited number of sites outside the lungs. The progression of NSCLC can vary, with some patients experiencing a gradual worsening of symptoms over time.

Trial ID:

2023-503326-39-00

Protocol code:

CSET N° 2023/3729

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Cemiplimab and Drug Combination for Patients with Oligometastatic Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?