Actively Recruiting
Phase I Trial of CArbonic Anhydrase Inhibition in Combination With Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma
Led by Centre Antoine Lacassagne · Updated on 2026-01-20
27
Participants Needed
2
Research Sites
403 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators propose to study the carbonic anhydrase inhibition (acetazolamide) associated with concomitant radiochemotherapy or radioimmunotherapy in small cell lung cancer due to: 1. The over-expression of carbonic anhydrases in this type of cancer, 2. The Anti-tumor effect in preclinical acetazolamide in various tumor lines including neuroendocrine tumor lines, 3. The observed synergy between irradiation and inhibition of carbonic anhydrases, 4. Potential anti-tumor immune effect caused by decreased extracellular acidity.
CONDITIONS
Official Title
Phase I Trial of CArbonic Anhydrase Inhibition in Combination With Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Performance Status between 0 and 2
- Diagnosed with localized non-metastatic or extensive small cell lung cancer
- Starting radiotherapy combined with platinum and etoposide chemotherapy (localized SCLC) or completed 4 cycles of chemoimmunotherapy with platinum, etoposide, and immunotherapy (atezolizumab or durvalumab) for extensive SCLC
- Tumor evaluation using RECIST 1.1 and/or PERCIST 1.0 criteria
- Negative pregnancy test within 72 hours before first treatment if woman of childbearing potential
- Use of two effective contraception methods or surgical sterilization for women of childbearing potential during and for 1 month after treatment
- Male participants with female partners of childbearing age must use contraception from first treatment to 1 month after last treatment
- Able and willing to provide written informed consent
- Affiliated with a health insurance system
You will not qualify if you...
- Presence of metastatic disease
- Previous thoracic irradiation or irradiation near the thoracic field
- Refusal or inability to participate in the study
- Contraindications to thoracic radiotherapy including unbalanced congestive heart failure (ejection fraction <30%) or severe respiratory failure such as grade IV COPD, oxygen dependence, FEV1 <40% predicted, DLCO <40% predicted, or vital capacity <40% predicted
- Contraindications to acetazolamide including hypersensitivity, severe liver, kidney or adrenal insufficiency, sulfonamide intolerance, history of renal colic, or wheat allergy (except celiac disease)
- Currently receiving prohibited treatments as specified in the protocol
- History of cancer except for those in complete remission over 5 years, completely resected basal cell or squamous cell skin carcinoma, or in situ cervical cancer
- Persons vulnerable under French Healthcare Code including those deprived of freedom, under legal protection, or pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
2
Centre Hospitalier Princesse grace
Monte Carlo, Monaco
Terminated
Research Team
J
Jérôme DOYEN, PH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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