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

Verified siteRegistered drugNo placebo
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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 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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

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

8 criteria

  • 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 trial?

5 criteria

  • 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.
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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.

What is already known about the treatment

Tusamitamab ravtansine – This medication is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic non-small-cell lung cancer, specifically in patients with a certain protein expression. The main therapeutic use of tusamitamab ravtansine is to target and kill cancer cells. It works by attaching to a specific protein on the cancer cells and delivering a toxic substance that helps to destroy them. This medication is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509115-84-00Protocol codeACT16146Estimated enrolment14 patientsSponsorSanofi-Aventis Recherche & Developpement

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