Study on the Effects and Safety of Cemiplimab and BNT116 in Adults with Advanced Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Advanced Non-Small Cell Lung Cancer (NSCLC). The study is investigating the effects of a new treatment combination involving two medications: Cemiplimab and BNT116. Cemiplimab is an anti-PD-1 antibody, which is a type of protein that helps the immune system fight cancer cells. BNT116 is a cancer vaccine designed to help the body recognize and attack cancer cells more effectively.

The purpose of this study is to understand how well the combination of Cemiplimab and BNT116 works compared to Cemiplimab alone in treating patients with advanced NSCLC. Participants in the study will receive either the combination treatment or Cemiplimab by itself. The study will monitor the response of the cancer to these treatments over a period of time. The treatments are given through an intravenous method, which means they are administered directly into the bloodstream.

Throughout the study, researchers will observe how the cancer responds to the treatments and will also keep track of any side effects that may occur. The study aims to provide valuable information on the safety and effectiveness of using these treatments together for patients with advanced NSCLC. The trial is expected to continue for several years to gather comprehensive data on the outcomes of the treatments.

1 enrollment and initial assessment

Upon joining the study, participants will undergo an initial assessment to confirm eligibility. This includes providing a tumor tissue sample and undergoing imaging tests such as a CT or MRI scan to measure any lesions.

Participants must have a performance status that allows them to carry out daily activities with minimal assistance.

2 treatment initiation

Participants will begin treatment with either a combination of cemiplimab and BNT116 or cemiplimab alone. The specific treatment will be determined by the study protocol.

Cemiplimab is administered as an intravenous infusion. The dosage and frequency will be specified by the study team.

3 ongoing treatment and monitoring

Participants will continue to receive their assigned treatment over a specified period. Regular monitoring will occur to assess the response to treatment and any side effects.

Participants will undergo periodic imaging tests to evaluate the size and progression of the cancer.

4 response evaluation

The response to treatment will be evaluated using criteria that measure changes in tumor size and progression.

This evaluation will be conducted by an independent review committee to ensure objectivity.

5 completion of treatment

Upon completion of the treatment phase, participants will undergo a final assessment to determine the overall response to the therapy.

Participants will be monitored for any long-term effects or changes in their condition.

Who Can Join the Study?

Participants must have a type of lung cancer called Advanced Non-Small Cell Lung Cancer (NSCLC).
The cancer must be either non-squamous or squamous and at stage IIIB, IIIC, or IV. This means the cancer is advanced and cannot be removed by surgery or treated with a combination of chemotherapy and radiation.
Participants should not have received any previous treatment for their advanced or spreading NSCLC.
A sample of the tumor tissue must be available, either from a previous test or collected during the study.
The tumor must show an expression of a protein called Programmed cell death ligand-1 (PD-L1) in at least 50% of the tumor cells.
Participants must have at least one tumor that can be measured using a scan like a CT (Computerized Tomography) or MRI (Magnetic Resonance Imaging).
Participants must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which means they are fully active or have some symptoms but do not need bed rest during the day.
Other specific criteria defined in the study protocol may apply.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients who do not have Advanced Non-Small Cell Lung Cancer cannot participate.
Patients whose tumors do not express PD-L1 in at least 50% of tumor cells cannot participate. PD-L1 is a protein that can affect the immune system’s ability to fight cancer.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population may not be eligible. This includes groups who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk	Lublin	Poland

Other Sites

Site Name	City	Country
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
LungenClinic Grosshansdorf GmbH	Grosshansdorf	Germany
Muenchen Klinik gGmbH	Munich	Germany
Klinikverbund Allgaeu gGmbH	Kempten (Allgau)	Germany
Med Polonia Sp. z o.o.	Poznan	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Martha-Maria Krankenhaus Halle-Doelau gGmbH	Halle (Saale)	Germany
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu	Torun	Poland
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Gmvinh Uarrkdbwng Fkwwyzeay	Frankfurt	Germany
Hzevmyjv Uobqatmhxzucu Hvwsuqqi Tdiiy y Poijtm Idualbsa Ccrang dmrhptjwqfqyjvien (vfre	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	14.11.2023
Poland	Not yet recruiting	14.11.2023
Spain	Not recruiting	14.11.2023

Trial locations

Investigated drugs:

Cemiplimab is a type of medication known as an anti-PD-1 antibody. It works by helping your immune system recognize and attack cancer cells. In this trial, cemiplimab is being used to treat patients with advanced non-small cell lung cancer (NSCLC) whose tumors have a high level of a protein called PD-L1. This medication can be used alone or in combination with another treatment to see which approach is more effective.

BNT116 is a new type of treatment being tested in this trial. It is designed to work with cemiplimab to help your immune system fight cancer more effectively. BNT116 is part of a group of treatments called FIXVAC, which are being developed to target specific types of cancer, like lung cancer. The goal of using BNT116 in combination with cemiplimab is to see if it can improve the treatment outcomes for patients with advanced non-small cell lung cancer.

Investigated diseases:

Non-small cell lung cancer

Advanced Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the epithelial cells lining the lungs and is characterized by larger cell size compared to small cell lung cancer. It is the most common form of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and spread to nearby tissues and organs, often forming tumors. As it advances, it can metastasize to other parts of the body, such as the brain, bones, and liver. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing rapid growth and others having a slower course.

Trial ID:

2023-503221-19-00

Protocol code:

R2810-ONC-2045

NCT ID:

NCT05557591

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects and Safety of Cemiplimab and BNT116 in Adults with Advanced Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

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