Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Randomized, open-label, Phase 3 study of SAR408701 versus docetaxel in previously treated, metastatic nonsquamous, non-small-cell lung cancer patients with CEACAM5-positive tumors

This study is looking into a new treatment called SAR408701 for people with a type of advanced lung cancer (non-small cell lung cancer) that has already been treated and has spread. It's designed to compare this new medicine with a common chemotherapy treatment called docetaxel. Researchers want to find out if SAR408701 can help people live longer, keep their cancer from growing for longer, and improve how they feel day-to-day. The study will also look at any side effects and how the treatment affects their quality of life. Participants will be randomly assigned to receive either the new drug or the standard chemotherapy.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

Start

05 Nov 2024

Non-small cell lung cancer metastatic

What is this study about?

This study is called a Phase 3 clinical trial, which means it's one of the final steps before a new treatment might become widely available. Doctors are comparing a new medication, SAR408701, to a chemotherapy drug called docetaxel that is already used. Both treatments are for a specific type of lung cancer called non-small cell lung cancer, which has spread to other parts of the body (metastatic) and has already been treated before. The main goal is to see if the new medicine is better than docetaxel at slowing down the cancer's growth and helping people live longer.

Researchers will also be carefully watching how people taking part in the study feel. This includes looking at their overall health and how the treatment impacts their daily lives, such as their ability to do everyday activities. They will also be recording any side effects that occur with each treatment.

The study focuses on patients whose cancer cells have a particular marker called CEACAM5. This means the new treatment is designed to target these specific cells, so it's important to know if your cancer has this marker. By comparing the new drug to a standard treatment, doctors hope to find better and more effective ways to treat this challenging type of lung cancer.

Key takeaways

Compares a new drug (SAR408701) to standard chemotherapy (docetaxel).
For advanced non-small cell lung cancer that has spread and been treated before.
Looks at how long cancer is controlled and overall survival.
Also assesses quality of life and side effects.
You must have a specific marker (CEACAM5) on your cancer cells.
Participation involves regular clinic visits for treatment and monitoring.

Who may be eligible?

This study is for adults aged 18 and over who have a specific type of lung cancer. This cancer is called non-small cell lung cancer, and it needs to have spread to other parts of the body (metastatic).

Additionally, you must have already received some treatment for your lung cancer, and your cancer cells need to be positive for a specific marker called CEACAM5. Both men and women can take part in this study. Your doctor will be able to check if your cancer meets these specific requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have non-small cell lung cancer that has spread?
Have you already received previous treatment for your lung cancer?
Does your cancer have the CEACAM5 marker?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the new drug (SAR408701) or the standard chemotherapy (docetaxel). This means neither you nor your doctor can choose which treatment you get. You would have regular visits to the clinic for your treatment and to have various tests, like blood tests, scans, and physical exams, to see how your body is responding to the treatment and to check for any side effects. You would also be asked to answer questions about how you are feeling and your quality of life. The exact number of visits and the full duration of your participation would depend on how your treatment is going and would be explained in detail by the study team.

Potential risks and benefits

Potential benefits of joining this study include the chance to receive a new treatment that might be more effective than current options, and contributing to medical knowledge that could help future patients. However, there's no guarantee the new treatment will work for you, and it might have side effects, just like any medication. The study team will carefully monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'Phase 3'?

Phase 3 means this is one of the last stages of testing a new medicine. It means the medicine has already been tried in smaller groups of people and looks promising, so now it's being compared to existing treatments.

What does 'metastatic' mean?

Metastatic means that the cancer has spread from where it started to other parts of the body.

What does 'randomized' mean?

Randomized means that people taking part are put into different treatment groups by chance, like flipping a coin. This ensures the study results are fair.

What is CEACAM5-positive?

This refers to a specific marker found on some cancer cells. The new treatment is designed to target cells that have this particular marker.

Will I know if I'm getting the new drug or chemotherapy?

Yes, this is an 'open-label' study, which means both you and your doctor will know which treatment you are receiving.