A trial looking at tusamitamab ravtansine for non small cell lung cancer (CARMEN-L03)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Open

Phase:

Phase 3

This trial is comparing tusamitamab ravtansine (SAR408701) to docetaxel to treat non small cell lung cancer. 

It is open to people with non small cell cancer that has spread to another part of the body.

More about this trial

Docetaxel is a chemotherapy drug that doctors use to treat non small cell lung cancer. 

Some cancers including lung cancers have a protein called CEACAM5 on their surface. 

Tusamitamab ravtansine is a antibody drug conjugate. It is a combination of a monoclonal antibody Open a glossary item and a chemotherapy drug called ravtansine or DM4. The monoclonal antibody attaches to the CEACAM5 protein on the cancer cell and then releases DM4 into the cancer cell. 

Researchers think that tusamitamab ravtansine might be as good as or better than docetaxel for non small lung cancer. 

In this trial half the people have tusamitamab ravtansine and the other half have docetaxel.

The aims of this trial are to find out:

  • how well tusamitamab ravtansine works compared to docetaxel
  • more about the side effects of tusamitamab ravtansine
  • what happens to it in the body 
  • how it affects quality of life Open a glossary item

Who can enter

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this trial if all of the following apply. 

  • You have non small cell lung cancer (NSCLC) that has spread to another part of the body and got worse during or after treatment. 
  • You have had at least 2 cycles of treatment Open a glossary item with a platinum drug Open a glossary item and a PD1 or PDL-1 checkpoint inhibitor Open a glossary item drug.
  • If your cancer has certain gene Open a glossary item changes (mutations Open a glossary item) you must also have had treatments that target these changes. Your doctor will know if you have had any of these drugs. 
  • You have cancer that has a large number of the CEACAM5 protein. The team will test for this using a tissue sample (biopsy Open a glossary item) that has already been taken. If this isn’t available you must be willing to have a fresh biopsy taken.
  • You have at least 1 area of cancer that the doctor can measure.
  • You have satisfactory blood test results.
  • You can look after yourself but might not be able to do heavy physical work (performance status 0 or 1).
  • You are willing to use contraception during treatment and for a time after. That is if there is any chance you or your partner could become pregnant.
  • You are at least 18 years old.

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

  • have cancer spread to the brain or spinal cord. This is unless you have had treatment, the spread is stable and you don’t need steroids within 2 weeks of starting treatment. 
  • have had any other chemotherapy or immunotherapy Open a glossary item other than those listed above to treat your cancer spread.
  • are having any other treatment for your cancer
  • had another cancer within the past 3 years. This is apart from successfully treated non melanoma skin cancer Open a glossary item, carcinoma in situ Open a glossary item of the cervix and some other cancers that your doctor will know about.  
  • have moderate to severe ongoing side effects from previous treatment. This is apart from vitiligo, hair loss and thyroid problems that are controlled with hormone replacement. 
  • have had docetaxel, a drug that targets the CEACAM5 protein or a drug called DM1 or DM4. Your doctor will know if you have. 
  • have another treatment within 3 weeks of starting this treatment
  • have an experimental drug or use a device as part of another clinical trial within 3 weeks of starting treatment 

Medical conditions
You cannot join this trial if any of these apply. You:

  • have HIV, hepatitis B or hepatitis C
  • have problems with the outer clear layer of your eye (cornea) that might affect you taking part. If you use contact lenses you must be willing not to use them while having treatment. 
  • are taking medication including herbal preparations that affects the CYP enzymes. This is unless you can stop using them for at least 2 weeks before starting treatment and during treatment.
  • have major surgery within 3 weeks of starting treatment
  • are not able to have corticosteroids 
  • have any other medical condition, mental health problem or a social situation that could affect you taking part

Other
You cannot join this trial if any of these apply. You:

  • are allergic or very sensitive to any of the treatments or their ingredients used in the trial
  • are pregnant or breastfeeding

Trial design

The trial team ask for a piece of cancer tissue. This can be from a previous sample of tissue (biopsy Open a glossary item) if it is available. If this isn’t available you must be willing to have a fresh sample taken. 

The trial team use this piece of tissue to test for the CEACAM5 protein on the cancer cells. You can only take part in the trial if the cancer cells have a certain amount of this protein. 

If the cancer cells don’t have enough of the protein your doctor will talk to you about what your treatment choices are. 

This is an international phase 3 trial. The team need 554 people worldwide to join with between 6 and 20 people from the UK.

It is a randomised trial. There are 2 treatment groups. Neither you nor your doctor chooses which group you go into. The 2 groups are:

  • tusamitamab ravtansine
  • docetaxel

You have tusamitamab ravtansine as a drip into a vein. You have it once every 2 weeks. Each 2 week period is a cycle of treatment Open a glossary item

You have docetaxel as a drip into a vein. You have it once every 3 weeks. Each 3 week period is a cycle of treatment. You have 6 cycles of docetaxel. 

The team anticipate you will have tusamitamab ravtansine for 6½ months. You might have it for longer if it is helping and the side effects aren’t too bad.  

Quality of life 
You fill in a questionnaire:

  • before starting treatment
  • at regular times while you are having treatment
  • when you finish treatment
  • at regular times during follow up

The questions ask about:

  • your general health and wellbeing
  • what you are able to do 
  • side effects
  • symptoms 

This is a quality of life questionnaire.

Samples for research 
You give extra blood samples during the trial. Where possible the team take these when you have your routine blood tests taken. 

Researchers use these samples to:

  • find out what happens to tusamitamab ravtansine in the body and how it affects the body
  • look for antibodies Open a glossary item to tusamitamab ravtansine
  • look for small pieces of DNA (ctDNA Open a glossary item)

Hospital visits

You see the doctor to have tests before taking part. These tests include:

  • a physical examination Open a glossary item
  • blood tests
  • heart trace (ECG Open a glossary item)
  • eye test
  • CT scan or MRI scan 

You see the doctor during treatment at regular times. This is to see how you are and for blood tests. 

When you finish treatment you see the doctor for the same tests you had at the start. 

You have a scan every 8 weeks until your cancer gets worse. If your cancer doesn’t get worse you then have a scan every 12 weeks.

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 
 
Tusamitamab ravtansine is a new drug and there might be side effects we don’t know about yet. The most common side effects reported are:

We have information about docetaxel and its side effects.

Location

London
Middlesbrough
Truro

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Jo Evans

Supported by

Sanofi

Freephone 0808 800 4040

Last review date

CRUK internal database number:

18461

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

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"I am glad that taking part in a trial might help others on their own cancer journey.”

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