BridgeMD
Phase I trial of CArbonic Anhydrase Inhibition in combination with radiochemotherapy or radioimmunotherapy in small cell lung carcinoma (ICAR)
EU CTIS ID: 2022-503093-36-00
What this study is testing
The main objective is to determine the Maximum Tolerated Dose (MTD) and Recommended Dose (RD) of acetazolamide in combination with : - Radiotherapy combined with platinum-based chemotherapy and etoposide (subgroup "localised CPC"), - Radiation therapy combined with atezolizumab or durvalumab immunotherapy (extended CPC subgroup).
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age greater than or equal to 18 years,
- for extended CPC Patient with histologically proven CPC, not localised to the chest,
- for extended CPC Patient eligible for first line chemoimmunotherapy,
- for extended CPC Patient who has received at least 1 cycle of chemoimmunotherapy (maximum 4 cycles) with platinum salts, etoposide and immunotherapy (atezolizumab or durvalumab) as first treatment for their extended CPC
- for extended CPC Patient responds or is stable according to RECIST 1.1 criteria and/or PERCIST 1.0 criteria after platinum-based chemoimmunotherapy, etoposide and immunotherapy (atezolizumab or durvalumab)
- Performance Status 0 to 2,
You likely can't join if
- Previous thoracic irradiation or near/in the thoracic irradiation field, without possible re-irradiation
- Contraindication to thoracic radiotherapy treatment: unbalanced congestive heart failure (ejection fraction < 30%, clinical signs), severe respiratory failure
- Vulnerable persons
- for localized CPC : Patient with metastatic disease
See the full eligibility criteria
- Age greater than or equal to 18 years,
- for extended CPC Patient with histologically proven CPC, not localised to the chest,
- for extended CPC Patient eligible for first line chemoimmunotherapy,
- for extended CPC Patient who has received at least 1 cycle of chemoimmunotherapy (maximum 4 cycles) with platinum salts, etoposide and immunotherapy (atezolizumab or durvalumab) as first treatment for their extended CPC
- for extended CPC Patient responds or is stable according to RECIST 1.1 criteria and/or PERCIST 1.0 criteria after platinum-based chemoimmunotherapy, etoposide and immunotherapy (atezolizumab or durvalumab)
- Performance Status 0 to 2,
- Measurable lesion according to RECIST 1.1 criteria and/or PERCIST 1.0 criteria
- If the patient is a woman of childbearing age, she must be surgically sterile or agree to use two adequate methods of contraception
- If the male patient has one or more female partners of childbearing age, he must agree to use an adequate method of contraception
- Patient affiliated to a social security scheme
- for localized CPC : Patient with histologically proven CPC, located in the chest, non-metastatic
- for localized CPC : Treatment-naive patient with localized CPC
- for localized CPC : Patient to be started on radiotherapy combined with platinum-based chemotherapy and etoposide
- Previous thoracic irradiation or near/in the thoracic irradiation field, without possible re-irradiation
- Contraindication to thoracic radiotherapy treatment: unbalanced congestive heart failure (ejection fraction < 30%, clinical signs), severe respiratory failure
- Vulnerable persons
- for localized CPC : Patient with metastatic disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.