Study on Cemiplimab and OSE2101 for Maintenance Therapy in Patients with ctDNA Positive Non-Small Cell Lung Cancer (NSCLC)

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC). The study will explore the effects of a combination of treatments, including Cemiplimab (also known by its code name REGN2810), OSE2101 (TEDOPI®), and possibly Pemetrexed. Cemiplimab is a medication given through an infusion, which means it is delivered directly into the bloodstream. TEDOPI® is administered as an injection, and Pemetrexed is also given by infusion.

The purpose of this study is to see how well these treatments work together in patients with NSCLC who have a specific genetic marker called HLA-A2 and have not shown disease progression after initial treatment. The study will compare the effectiveness of the combination of TEDOPI® and Cemiplimab against Cemiplimab alone, with or without Pemetrexed, which is considered the standard maintenance treatment. The main focus is on how these treatments affect the presence of cancer-related DNA in the blood, known as ctDNA.

Participants in the study will receive their assigned treatments over a period of time, and their health will be monitored to assess the impact of the treatments. The study aims to gather information on overall survival, how long patients live without the cancer getting worse, and the overall response to the treatment. Additionally, the study will look at any side effects experienced by participants and how other biological markers, such as PD-L1 and TMB, relate to treatment outcomes.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will need to provide a signed informed consent before any trial-specific procedures begin.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying a diagnosis of non-small cell lung cancer (NSCLC) and checking if you are HLA-A2 positive.

3 treatment allocation

You will be randomly assigned to one of the treatment groups. One group will receive cemiplimab plus TEDOPI, and the other group will receive cemiplimab with or without pemetrexed.

4 treatment administration

If you are in the cemiplimab plus TEDOPI group, you will receive LIBTAYO 350 mg as a concentrate for solution for infusion and TEDOPI as an emulsion for injection.

If you are in the cemiplimab with or without pemetrexed group, you will receive LIBTAYO 350 mg as a concentrate for solution for infusion and Armisarte 25 mg/ml as a concentrate for solution for infusion if pemetrexed is included.

5 treatment schedule

The treatment will be administered according to the schedule provided by the study team. The frequency and duration of administration will be explained to you in detail.

6 monitoring and follow-up

Throughout the trial, your health and response to the treatment will be closely monitored. Regular follow-up visits will be scheduled to assess your condition and any side effects.

7 end of trial

The trial is expected to end by April 6, 2029. At the end of the trial, you will have a final assessment to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Confirmed diagnosis of advanced or metastatic non-small-cell lung cancer (NSCLC) that is not driven by specific genetic changes. This means the cancer is either locally advanced and cannot be treated with a combination of chemotherapy and radiation, or it has spread to other parts of the body.
Eligible for first-line treatment with a combination of chemotherapy and immunotherapy, regardless of PD-L1 levels. PD-L1 is a protein that can affect how the immune system responds to cancer.
Positive for HLA-A2, which is a specific type of protein found on the surface of cells that is important for the immune system.
Have an ECOG Performance Status of 0-1. This 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 nearly fully active.
Must provide signed informed consent before participating in any trial-specific procedures. This means you understand the trial and agree to participate.
Open to both male and female participants.
Participants must be within the specified age range for the trial.

Who Cannot Join the Study?

Patients who do not have HLA-A2 positive status. HLA-A2 is a specific type of protein found on the surface of cells that is important for the immune system.
Patients whose non-small cell lung cancer (NSCLC) is still progressing after 4 cycles of chemoimmunotherapy. Chemoimmunotherapy is a treatment that combines chemotherapy and immunotherapy to fight cancer.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Ospedaliera Di Perugia	Perugia	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Iarexf Iozzskxm Fanxuqquarjoj Odpdsmoolxm	Rome	Italy
Iniuynhv Rxddrtmck Paz Lc Soqzdt Djo Tckety Dntx Awjmugx Iqva Sqqcyc	Meldola	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	07.04.2025

Trial locations

Investigated drugs:

Cemiplimab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is used to help maintain the progress made after initial treatment in patients with a specific type of lung cancer.

OSE2101 (TEDOPI®) is a therapeutic cancer vaccine. It is designed to stimulate your immune system to target and destroy cancer cells. In this study, it is used alongside cemiplimab to see if it can help clear cancer-related DNA from the blood, which may indicate a reduction in cancer activity.

Pemetrexed is a chemotherapy drug that works by interfering with the growth of cancer cells, slowing or stopping their spread. In this trial, it is used as part of the standard maintenance treatment to help keep the cancer from growing after initial therapy.

Investigated diseases:

Non-small cell lung cancer

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer (NSCLC) 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 epithelial cells lining the lungs and is characterized by the formation of malignant tumors. The disease progresses as these cancerous cells grow uncontrollably, potentially spreading to other parts of the body. NSCLC is often associated with symptoms like persistent cough, chest pain, and shortness of breath. As the cancer advances, it may invade nearby tissues and organs, leading to further complications. The progression of NSCLC can vary significantly depending on the subtype and individual patient factors.

Trial ID:

2024-519262-42-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Cemiplimab and OSE2101 for Maintenance Therapy in Patients with ctDNA Positive Non-Small Cell Lung Cancer (NSCLC)

What is this study about?

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