Study of Tusamitamab Ravtansine with Pembrolizumab and Chemotherapy for Advanced Non-Small Cell Lung Cancer Patients

2 1 1 1

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), specifically the nonsquamous type. The study involves testing a combination of medications to see how well they work together in treating this cancer. The medications being studied include tusamitamab ravtansine (also known by its code name SAR408701), pembrolizumab (commonly known as Keytruda), and platinum-based chemotherapy drugs such as carboplatin and cisplatin, with or without the addition of pemetrexed.

The purpose of the study is to assess the safety and effectiveness of these drug combinations in patients with advanced or metastatic NSCLC that shows positive expression of a protein called CEACAM5. The study is divided into two parts: an initial phase to determine the best doses of the medications, followed by an expansion phase to evaluate how well the treatment works in a larger group of patients. Participants will receive the medications through an intravenous infusion, which means the drugs are given directly into a vein.

Throughout the study, researchers will monitor participants for any side effects and measure how the cancer responds to the treatment. The study aims to find the most effective dose levels and combinations of these medications to improve treatment outcomes for patients with this type of lung cancer. The trial is expected to continue until 2026, allowing researchers to gather comprehensive data on the safety and potential benefits of the treatment combinations.

1 joining the trial

Upon joining the clinical trial, you will be informed about the study’s purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the information provided.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history, performing physical examinations, and conducting necessary tests to ensure you meet the study criteria.

3 treatment phase

During the treatment phase, you will receive a combination of medications through intravenous use. The medications include tusamitamab ravtansine, pembrolizumab, and possibly platinum-based chemotherapy with or without pemetrexed. The specific dosage and frequency will be determined by the study protocol and your healthcare team.

The treatment is administered in cycles, with each cycle lasting 21 days. You will be monitored closely for any side effects or reactions to the medications.

4 monitoring and follow-up

Throughout the trial, regular monitoring will be conducted to assess your response to the treatment and to check for any adverse effects. This includes blood tests, imaging studies, and other necessary evaluations.

You will have scheduled visits with the study team to discuss your progress and any concerns you may have.

5 end of treatment

At the end of the treatment phase, a final assessment will be conducted to evaluate the overall effects of the treatment on your condition. This will include a comprehensive review of your health status and any changes observed during the trial.

6 post-trial follow-up

After completing the trial, you may be asked to participate in follow-up visits to monitor your long-term health and any lasting effects of the treatment. This helps in understanding the long-term impact of the medications used in the study.

Who Can Join the Study?

Diagnosis of advanced or metastatic NSQ NSCLC (a type of lung cancer) confirmed by a lab test, with no specific genetic changes like EGFR, BRAF, or ALK/ROS.
No previous chemotherapy for advanced or metastatic disease. Previous chemotherapy or radiation is allowed if it was completed at least 6 months before the advanced disease diagnosis.
Presence of CEACAM5 protein in the tumor, shown by a lab test, with at least 1% of tumor cells showing this protein.
Measurable disease according to RECIST 1.1, a standard way to measure tumor size and response to treatment.
ECOG performance status of 0-1, which means the patient is fully active or has some symptoms but can carry out light work.
Use of contraception by men or women should follow local rules for clinical studies.
Life expectancy of at least 3 months.
Open to both male and female participants.

Who Cannot Join the Study?

Patients who do not have a diagnosis of cancer.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included.
Patients who are not considered part of a vulnerable population.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Not recruiting	25.03.2021

Trial locations

Investigated drugs:

Tusamitamab ravtansine is a type of medication known as an antibody-drug conjugate. It is designed to target and attach to specific proteins found on the surface of cancer cells, particularly in certain types of lung cancer. Once attached, it delivers a powerful drug directly into the cancer cell, which can help to kill the cancer cells and stop them from growing. This medication is being studied to see how well it works when used alone or in combination with other treatments for advanced lung cancer.

Pembrolizumab is a type of immunotherapy. It works by helping your immune system recognize and attack cancer cells. Normally, cancer cells can hide from the immune system, but pembrolizumab blocks this hiding mechanism, allowing your body’s natural defenses to find and destroy the cancer cells. It is used in the treatment of various types of cancer, including lung cancer, and is being tested in combination with other treatments to see if it can improve outcomes for patients.

Platinum-based chemotherapy refers to a group of chemotherapy drugs that contain the metal platinum. These drugs work by damaging the DNA of cancer cells, which prevents them from dividing and growing. They are commonly used in the treatment of lung cancer and are being studied in combination with other therapies to see if they can enhance the effectiveness of treatment.

Pemetrexed is a chemotherapy drug that works by interfering with the ability of cancer cells to use folate, a type of vitamin B, which is necessary for them to grow and divide. By blocking this process, pemetrexed can help to slow down or stop the growth of cancer cells. It is often used in the treatment of non-small cell lung cancer and is being tested in combination with other treatments to determine if it can improve patient outcomes.

Investigated diseases:

Non-small cell lung cancer

Non-Small Cell Lung Cancer (NSCLC) – Non-Small Cell Lung Cancer is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It generally starts in the tissues of the lungs and can spread to other parts of the body. The disease progresses through stages, beginning with localized tumors and potentially advancing to involve lymph nodes and distant organs. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the disease advances, it can lead to more severe respiratory issues and systemic symptoms. The progression rate can vary based on the subtype and individual patient factors.

Trial ID:

2023-509115-84-00

Protocol code:

ACT16146

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Tusamitamab Ravtansine with Pembrolizumab and Chemotherapy for Advanced Non-Small Cell Lung Cancer Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?