Study of Cemiplimab, Carboplatin, and Paclitaxel for Adults with Operable 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), a type of lung cancer that can be surgically removed. The study will explore the effectiveness of a medication called cemiplimab, used in combination with chemotherapy and other cancer treatments. Chemotherapy involves using drugs to kill cancer cells, and in this study, the specific chemotherapy drugs include carboplatin, paclitaxel, cisplatin, and pemetrexed. Additionally, a new treatment called REGN7075 will be tested, which is a type of bispecific antibody, a protein designed to target cancer cells.

The purpose of the study is to evaluate how well these treatments work together in reducing the size of the tumor before surgery and improving the overall outcomes for patients. Participants will receive these treatments through an intravenous (IV) infusion, which means the medication is given directly into a vein. The study will compare the results of using cemiplimab with chemotherapy alone versus cemiplimab with chemotherapy plus other cancer treatments. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments being studied.

The study will take place over several months, with regular visits to monitor the participants’ health and the effectiveness of the treatment. The goal is to find the best combination of treatments to improve the chances of successful surgery and long-term recovery for patients with resectable NSCLC. Participants will be closely monitored for any side effects or changes in their condition throughout the study period.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as having a resectable form of non-small cell lung cancer (NSCLC) and meeting health and performance standards.

2 initial treatment phase

The initial treatment phase involves receiving cemiplimab combined with chemotherapy. This includes medications like carboplatin, paclitaxel, pemetrexed, and cisplatin, administered through an intravenous (IV) infusion.

The frequency and dosage of these medications are determined by the study protocol and are administered under medical supervision.

3 additional treatment phase

In this phase, additional cancer treatments may be introduced alongside cemiplimab and chemotherapy. This could include novel treatments like REGN7075, also administered via IV infusion.

The goal is to evaluate the effectiveness of these combined treatments in reducing tumor size before surgery.

4 surgical evaluation

Following the treatment phases, an evaluation is conducted to determine the response of the cancer to the treatments. This includes assessing the tumor’s size and viability.

The results of this evaluation help decide the timing and feasibility of surgery.

5 surgery

If the evaluation indicates that surgery is possible, the patient undergoes a surgical procedure to remove the tumor.

The surgery aims to achieve a complete removal of the cancerous tissue.

6 post-surgery follow-up

After surgery, follow-up appointments are scheduled to monitor recovery and assess any remaining cancer activity.

This phase includes regular health checks and may involve additional treatments if necessary.

7 long-term monitoring

Long-term monitoring is conducted to track the patient’s health and detect any recurrence of cancer.

This involves periodic medical evaluations and may include further treatments based on the patient’s condition.

Who Can Join the Study?

The patient must have a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC).
The cancer must be at a stage between II and IIIB (N2), which means it is advanced but can still be removed with surgery.
The cancer must be measurable according to specific guidelines called Response Evaluation Criteria In Solid Tumors (RECIST).
The patient must provide a sample of their tumor that has been preserved in a special way, known as formalin-fixed paraffin-embedded (FFPE).
The patient must have a Performance Status score of 0 to 1 on a scale used to assess how well they can perform daily activities. This scale is called the Eastern Cooperative Oncology Group Performance Status (ECOG PS).
The patient must have organs and bone marrow that are working well enough, as specified in the study details.
The study is open to both male and female participants.
The study includes participants from a vulnerable population, which means people who might need extra protection or care.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Non-Small Cell Lung Cancer cannot participate. Non-Small Cell Lung Cancer is a common type of lung cancer.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not able to undergo surgery to remove the cancer cannot participate. Surgery is a procedure to take out the cancer from the body.
Patients who have other serious health conditions that might interfere with the study cannot participate. These are health problems that could make it unsafe to be in the study.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who have participated in another clinical trial recently cannot participate. This is to avoid any interference with the results of the study.
Patients who have allergies to the study medications cannot participate. An allergy is when your body reacts badly to something.
Patients who are unable to follow the study procedures cannot participate. This means they cannot do what is needed for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Universitaetsmedizin Goettingen	Goettingen	Germany
Hospital Clinico San Carlos	Madrid	Spain
Universitaet Leipzig	Leipzig	Germany
Hospital Universitario De Navarra	Pamplona	Spain
CHU Grenoble Alpes	La Tronche	France
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Universitaetsklinikum Aachen AöR	Aachen	Germany
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
MD Anderson Cancer Center	Madrid	Spain
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer	Toulon	France
HIA Sainte Anne	Toulon	France
Virgen del Rocío University Hospital	Sevilla	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hospital General Universitario De Valencia	Valencia	Spain
Klinikum Kassel GmbH	Kassel	Germany
Centre Hospitalier De La Cote Basque	Bayonne	France
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH	Hemer	Germany
Centre Hospitalier Universitaire De Rennes	Rennes	France
Ramsay Generale De Sante	Bayonne	France
Hxcayvnq Uqvrowtpjxugs Mmcrgaf Dw Vxdtrkvgky	Santander	Spain
Ifthxdzg Mcvfqcsqtv Mshnziwsvs	Paris	France
Isbouuhz Czvcpo Dplenshisjlawpmor	L'hospitalet De Llobregat	Spain
Foclhlohl Prwa Lx Ieusqqhxhmsvy Bulnuijat Dmq Hvtufvzy Unelaynulhrtj Lv Pgr	Madrid	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	31.10.2024
Germany	Recruiting	31.10.2024
Spain	Recruiting	31.10.2024

Trial locations

Investigated drugs:

Cemiplimab is a medication used in this trial to help the body’s immune system fight cancer cells. It is a type of treatment known as immunotherapy, which works by blocking a specific protein on the surface of cancer cells, allowing the immune system to better recognize and attack them.

Chemotherapy involves the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is combined with cemiplimab to enhance the overall effectiveness of the treatment against non-small cell lung cancer.

Novel Cancer Treatments refer to new and experimental therapies being tested in this trial. These treatments are combined with cemiplimab and chemotherapy to see if they can improve outcomes for patients with resectable non-small cell lung cancer. The specific details of these novel treatments are not provided, but they are part of the study to explore additional ways to combat cancer.

Investigated diseases:

Non-small cell lung cancer

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the cells lining the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms. Early detection is crucial for managing the disease effectively.

Trial ID:

2023-509806-31-00

Protocol code:

R2810-ONC-2268

NCT ID:

NCT06465329

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Cemiplimab, Carboplatin, and Paclitaxel for Adults with Operable Non-Small Cell Lung Cancer

What is this study about?

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