Study Comparing Tusamitamab Ravtansine and Docetaxel for Patients with Previously Treated Metastatic Non-Small Cell Lung Cancer with CEACAM5-Positive Tumors

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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 that has spread to other parts of the body, referred to as metastatic. The study is comparing two treatments: Tusamitamab ravtansine, which is also known by the code name SAR408701, and Docetaxel. Tusamitamab ravtansine is a special type of medication called a monoclonal antibody drug conjugate, which is designed to target specific cancer cells. Docetaxel is a chemotherapy drug that is commonly used to treat various types of cancer.

The purpose of this study is to determine if Tusamitamab ravtansine can improve the length of time patients live without their cancer getting worse, known as progression-free survival, and overall survival compared to Docetaxel. Participants in the study have previously been treated with standard chemotherapy and a type of medication called an immune checkpoint inhibitor. The study involves patients whose cancer cells show a specific protein called CEACAM5 at a certain level.

During the study, participants will receive either Tusamitamab ravtansine or Docetaxel through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the effects of the treatments over time, including any side effects and how the treatments impact the patients’ quality of life. The study aims to provide valuable information on which treatment might be more effective for patients with this type of lung cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of non-squamous non-small cell lung cancer (NSCLC) with metastatic disease, and previous treatment history.

Participants must have a tumor with a specific protein expression (CEACAM5) and agree to use effective contraception during and after the study.

2 randomization

Participants are randomly assigned to receive either tusamitamab ravtansine or docetaxel.

This process ensures that each participant has an equal chance of receiving either treatment.

3 treatment administration

Both medications are administered through an intravenous infusion.

Docetaxel is a chemotherapy drug, while tusamitamab ravtansine is an investigational drug being studied for its potential benefits.

4 monitoring and assessments

Participants undergo regular monitoring to assess the effectiveness of the treatment and any side effects.

Assessments include measuring tumor response and evaluating overall health and quality of life.

5 end of treatment

The study aims to determine if tusamitamab ravtansine improves progression-free survival and overall survival compared to docetaxel.

The study is expected to conclude by March 2026, with results analyzed to determine the success of the treatment.

Who Can Join the Study?

Must be at least 18 years old or older, or the legal age of maturity in your country, and have signed the informed consent form.
Must have a confirmed diagnosis of a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. The cancer must have worsened after treatment with platinum-based chemotherapy and an immune checkpoint inhibitor, which are types of cancer treatments.
Must have a specific protein called CEACAM5 present in a certain amount in at least 50% of the cancer cells. This will be checked using a test called immune histochemistry (IHC) on a sample of the tumor.
Must have at least one tumor that can be measured using a standard method called RECIST v1.1, which is a way to assess how the tumor responds to treatment.
Must have a good general health status, as measured by a score of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance status scale, which is used to assess how the disease affects daily living abilities.
If female, must agree to use highly effective birth control methods during the study and for at least 7 months after the last dose of the study treatment.
If male, must agree to use highly effective birth control methods during the study and for at least 6 months after the last dose of the study treatment.

Who Cannot Join the Study?

Patients who have not been previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor cannot participate.
Patients whose tumor cells do not express a protein called CEACAM5 at a level of 2+ intensity or higher in at least 50% of the tumor cell population are excluded.
Patients with a type of lung cancer other than non-small cell lung cancer that has spread to other parts of the body (metastatic) are not eligible.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which may include those unable to give informed consent, are excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	11.03.2020

Trial locations

SAR408701 is an investigational medication being studied for its potential to treat metastatic non-squamous non-small-cell lung cancer (NSCLC) in patients whose tumors express a specific protein called CEACAM5. This medication is being compared to another treatment to see if it can help patients live longer or delay the progression of their cancer.

Docetaxel is a chemotherapy drug that is commonly used to treat various types of cancer, including lung cancer. In this study, it serves as a comparison treatment to evaluate the effectiveness of the investigational medication SAR408701. Docetaxel works by interfering with the growth and spread of cancer cells in the body.

Investigated diseases:

Non-small cell lung cancer metastatic

Non-small cell lung cancer metastatic – This is a type of lung cancer that has spread from the lungs to other parts of the body. It is the most common form of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and form tumors in the lungs, which can then metastasize to other organs such as the brain, bones, or liver. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the cancer spreads, it can lead to more severe symptoms and complications. The progression of the disease can vary depending on factors like the patient’s overall health and the specific characteristics of the cancer cells.

Trial ID:

2024-515101-26-00

Protocol code:

EFC15858

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Tusamitamab Ravtansine and Docetaxel for Patients with Previously Treated Metastatic Non-Small Cell Lung Cancer with CEACAM5-Positive Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?