Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

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

7 criteria

  • 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 trial?

5 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • 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.

What is already known about the treatment

Tusamitamab Ravtansine – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic non-squamous non-small cell lung cancer (NSCLC) with CEACAM5-positive tumors. It is in the investigational stage and not yet approved for general medical use. The main therapeutic indication is for patients who have previously been treated with standard chemotherapy and immune checkpoint inhibitors. Tusamitamab ravtansine works by targeting the CEACAM5 protein on cancer cells, delivering a cytotoxic agent directly to the tumor, which helps to inhibit cancer cell growth. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a potent anti-cancer drug.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515101-26-00Protocol codeEFC15858Estimated enrolment197 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.