RecruitingPHASE1INTERVENTIONAL

Phase I Trial of CArbonic Anhydrase Inhibition in Combination With Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma

This study is exploring a new way to treat small cell lung cancer using a medicine called acetazolamide, which is already approved for other conditions. Researchers believe that cancer cells use energy differently than healthy cells, and that acetazolamide might be able to block this energy use. This could make existing treatments like radiotherapy and chemotherapy more effective. They are also looking at whether it can help the body's immune system fight the cancer. This first-stage study aims to see if combining acetazolamide with standard treatments for either early or advanced small cell lung cancer is safe and whether it shows promising anti-cancer effects. This is the first time this specific approach is being tested in people with cancer.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Centre Antoine Lacassagne

Enrolment target

Start

02 Aug 2019

Estimated completion

27 Apr 2027

Small Cell Lung Cancer

What is this study about?

This study is about small cell lung cancer and a new approach to treatment. Doctors are investigating whether an existing medicine, acetazolamide, can improve how well standard treatments like radiotherapy and chemotherapy work. Small cell lung cancer cells, like many cancer cells, are very busy and need a lot of energy to grow. They get this energy in a different way compared to healthy cells. Researchers think that acetazolamide might be able to interfere with this energy process, making it harder for cancer cells to thrive.

Acetazolamide is a medicine that's been used for a long time for other health conditions, so its general safety is well-known. However, it's never been tested in cancer patients before. Scientists have seen in laboratory studies that acetazolamide could have an anti-cancer effect and might even help radiotherapy work better. They also believe it could make the cancer's surroundings less acidic, which might help the body's immune system fight the cancer more effectively.

This is a 'Phase 1' study, which means it's one of the first times this combination is being tested in people. The main goals are to check if it's safe to give acetazolamide alongside existing treatments for small cell lung cancer, and to see if there are any early signs that it could be an effective treatment. The study is split into two groups: one for patients with localised small cell lung cancer who will get acetazolamide with traditional radiotherapy and chemotherapy, and another for patients with more widespread cancer who will get it with a newer treatment called radioimmunotherapy.

Key takeaways

This study investigates a new use for an existing medicine, acetazolamide, for small cell lung cancer.
It aims to make standard treatments (chemotherapy, radiotherapy, radioimmunotherapy) more effective.
Researchers believe acetazolamide may disrupt cancer cell energy use and help the immune system.
This is a Phase 1 study, focusing on safety and initial effectiveness in humans.
Participation involves taking acetazolamide alongside your standard cancer treatment.

Who may be eligible?

To be considered for this study, you need to be 18 years or older. You must have small cell lung cancer that is either localised (meaning it hasn't spread widely) or extensive (meaning it's more widespread) and your doctors must have decided on a treatment plan for your cancer. Your general health should be good enough to take part in a clinical trial, which doctors usually measure using a 'performance status' score.

For women who could become pregnant, you'll need to have a negative pregnancy test shortly before starting the study treatment. You must also agree to use two reliable methods of contraception throughout the study and for one month afterwards. For men with female partners who could become pregnant, you'll also need to use reliable contraception during the study and for one month after. Everyone taking part must be willing to give their written permission to join the study and be covered by a health insurance system.

There are also reasons why you might not be able to join. For example, if your cancer has already spread to other parts of your body (metastatic disease), or if you've already had radiotherapy in your chest area before. Also, if you simply don't want to take part, that's perfectly fine.

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 small cell lung cancer (localised or extensive)?
Are you able to start radiotherapy/chemotherapy or have you completed 4 cycles of chemoimmunotherapy?
Are you generally well enough to take part in a study?
Are you willing to use contraception as required (if applicable)?
Are you willing to provide your written consent to join the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study drug, acetazolamide, along with your planned treatment for small cell lung cancer. This will be either standard chemotherapy (platinum and etoposide) plus radiotherapy if your cancer is localised, or radioimmunotherapy if your cancer is more widespread and you've already had initial chemoimmunotherapy. The specific timing and number of doses for acetazolamide will be explained by the study team.

You will have regular appointments for medical checks, scans, and blood tests to monitor your health, how well the treatment is working, and to check for any side effects. These assessments are similar to what you might expect during standard cancer treatment but might be more frequent or include extra tests specific to the study. The total length of your participation will depend on your treatment plan and condition, but you will be closely monitored throughout.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is that acetazolamide, when combined with your standard treatment, might improve how well your small cell lung cancer is treated. However, as this is a new combination, we don't know for sure if it will help, and it might not benefit everyone. Potential risks include side effects from acetazolamide itself, or from the combination with your existing treatments. The study team will carefully monitor you for any side effects and will explain them in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Centre Antoine Lacassagne
Verified postcode
Nice, France· Recruiting
Centre Hospitalier Princesse grace
Verified postcode
Monte Carlo, Monaco· Terminated

Common questions

What is acetazolamide?

Acetazolamide is a medicine already used for conditions like glaucoma and altitude sickness. In this study, we are exploring if it can also help treat small cell lung cancer.

Why is this study important?

This study is important because it's the first time we're testing this combination in people. It explores a new way to target cancer cells' energy supply and potentially make existing treatments more effective.

Will I still receive my usual cancer treatment?

Yes, you will still receive your planned standard treatments like chemotherapy, radiotherapy, or radioimmunotherapy. Acetazolamide would be given alongside these treatments.

What does a 'Phase 1' study mean?

A Phase 1 study is designed to check the safety of a new treatment or combination, find the right dose, and look for early signs of how it affects the disease. It's one of the first steps in testing a new treatment in people.

What if I experience side effects?

The study team will closely monitor you for any side effects. You should report any new or worsening symptoms immediately so they can provide appropriate care and advice.

How to find out more

Jérôme DOYEN, PH

jerome.doyen@nice.unicancer.fr +33492031270 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.