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Study on Acetazolamide with Radiochemotherapy or Radioimmunotherapy for Patients with Small Cell Lung Cancer

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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 small cell lung carcinoma. The study is exploring the use of a medication called acetazolamide, which is being tested in combination with other treatments. These treatments include radiochemotherapy—a combination of radiation therapy and chemotherapy—and radioimmunotherapy, which combines radiation therapy with immunotherapy drugs like atezolizumab or durvalumab.

The purpose of the study is to find the best dose of acetazolamide when used with these treatments. Participants will be divided into two groups based on their type of lung cancer. One group will receive acetazolamide with radiochemotherapy, which includes platinum-based chemotherapy and a drug called etoposide. The other group will receive acetazolamide with radioimmunotherapy. The study will last several weeks, and participants will be monitored for six months after their treatment ends to check for any side effects and to see how well the treatment works.

Throughout the study, the safety of acetazolamide will be closely monitored. Researchers will also assess how well the cancer responds to the treatment, using methods like RECIST and PERCIST evaluations, which help measure changes in tumor size and activity. Additionally, the study will look at factors that might predict how well a patient responds to acetazolamide, as well as overall survival and quality of life over a period of 24 months.

The research process

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

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
Eligibility criteria include being 18 years or older, having a confirmed diagnosis of small cell lung carcinoma, and meeting specific health and treatment history requirements.
Step 2
Treatment plan discussion
A detailed discussion of the treatment plan is provided. This includes information about the medications, their dosages, and the schedule for taking them.
The treatment involves taking Diamox 250 mg tablets orally. The dosage and frequency will be determined based on individual health needs and the study's objectives.
Step 3
Treatment phase for localized CPC
For patients with localized small cell lung carcinoma, the treatment phase includes 6-7 weeks of acetazolamide combined with radiochemotherapy. This involves platinum-based chemotherapy and etoposide.
The primary goal is to determine the maximum tolerated dose and recommended dose of acetazolamide in combination with these therapies.
Step 4
Treatment phase for extensive CPC
For patients with extensive small cell lung carcinoma, the treatment phase includes 10 days of acetazolamide combined with radioimmunotherapy. This involves immunotherapy with atezolizumab or durvalumab.
The focus is on assessing the safety and effectiveness of this combination.
Step 5
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to assess safety and response to treatment. This includes clinical evaluations and various tests.
The overall safety of the treatment is assessed using clinical, biological, and other methods. Tumor response is evaluated using specific criteria.
Step 6
End of treatment evaluation
After completing the treatment phase, an evaluation is conducted to assess the outcomes. This includes measuring progression-free survival and overall survival at 24 months.
Quality of life and treatment compliance are also assessed using standardized questionnaires.

Who can join the trial?

13 criteria

Age must be 18 years or older.
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For patients with extended CPC (cancer not limited to the chest):
- Must have a confirmed diagnosis of CPC.
- Eligible for first-line treatment with a combination of chemotherapy and immunotherapy.
- Must have received at least 1 cycle (up to 4 cycles) of treatment with platinum-based drugs, etoposide, and immunotherapy (atezolizumab or durvalumab).
- Must show a response or stable disease according to specific medical criteria (RECIST 1.1 and/or PERCIST 1.0) after the above treatments.
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  For patients with localized CPC (cancer limited to the chest):
  - Must have a confirmed diagnosis of CPC located in the chest and not spread to other parts of the body.
  - Must not have received any prior treatment for localized CPC.
  - Must be starting treatment with radiotherapy combined with platinum-based chemotherapy and etoposide.
  - Must have a Performance Status of 0 to 2, which indicates the ability to carry out daily activities.
  - Must have a measurable tumor according to specific medical criteria (RECIST 1.1 and/or PERCIST 1.0).
  - If the patient is a woman of childbearing age, she must be surgically sterile or agree to use two effective methods of birth control.
  - If the patient is a man with a female partner of childbearing age, he must agree to use an effective method of birth control.
  - Must be affiliated with a social security scheme.

Who cannot join the trial?

3 criteria

Patients who do not have lung carcinoma cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

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Verified sites

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Centre Leon Berard
Lyon, France

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Investigated drugs

Acetazolamide
is a medication that helps reduce the production of certain fluids in the body. In this trial, it is being tested to see how well it works when combined with other treatments for small cell lung cancer. The goal is to find out the best dose that can be used safely with other therapies.
Radiotherapy
is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, it is used in combination with other treatments to see if it can improve outcomes for patients with small cell lung cancer.
Platinum-based chemotherapy
refers to a group of cancer-fighting drugs that contain the metal platinum. These drugs work by damaging the DNA of cancer cells, which can help stop them from growing and dividing. In this trial, they are used alongside other treatments to see how effective they are in treating small cell lung cancer.
Etoposide
is a type of chemotherapy drug that works by preventing cancer cells from dividing and growing. It is used in this trial in combination with other therapies to see if it can help improve treatment outcomes for patients with small cell lung cancer.
Atezolizumab
is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. In this trial, it is combined with radiation therapy to see if it can enhance the treatment of small cell lung cancer.
Durvalumab
is another immunotherapy drug that boosts the immune system's ability to fight cancer. It is being tested in this trial alongside radiation therapy to determine its effectiveness in treating small cell lung cancer.

Acetazolamide

What is already known about the treatment

Acetazolamide – Acetazolamide is administered orally in tablet form and is currently being studied in clinical trials for its potential use in treating small cell lung carcinoma. It is being tested in combination with radiotherapy and chemotherapy or immunotherapy to determine the safest and most effective dose. Acetazolamide works by inhibiting an enzyme called carbonic anhydrase, which plays a role in various bodily functions, including the regulation of pH and fluid balance. It is classified as a carbonic anhydrase inhibitor and is being explored for its ability to enhance the effects of cancer treatments.

Investigated diseases

Lung Carcinoma – Lung carcinoma is a type of cancer that begins in the lungs, which are two spongy organs in the chest responsible for taking in oxygen and releasing carbon dioxide. It typically starts in the cells lining the bronchi and parts of the lung such as the bronchioles or alveoli. As the disease progresses, the cancer cells can grow uncontrollably and form tumors, which may interfere with the lung's ability to function properly. Over time, these cancerous cells can invade nearby tissues and spread to other parts of the body through the bloodstream or lymphatic system. The progression of lung carcinoma can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. The disease can vary in its rate of progression, depending on the type and stage of the cancer.