Recruiting

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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

8 criteria

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 trial?

8 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
CHU Grenoble Alpes
La Tronche, France
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

Trial locations

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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.

What is already known about the treatment

Cemiplimab – Cemiplimab is administered intravenously, typically as an infusion. It is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC). The main therapeutic indication for cemiplimab is as a treatment for certain types of cancer, including NSCLC. At the molecular level, cemiplimab works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

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.