Obstructive endobronchial non-small cell lung cancer MedDRA version: 9.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS
Conditions
Sponsors
STEBA BIOTECH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically proven lung cancer, - Inoperable, - Non-small cell cancer, - Partial or total bronchial obstruction responsible for functional signs, - T1 to T4, N0-N3, M0-M1, - Patients with functional signs: hemoptysis, infection, cough and, above all, dyspnea, - Contralateral metastases not representing a contraindication insofar as they do not represent a risk of impairment of respiratory function during treatment, - The Karnofsky index should be greater than or equal to 40, - Patients should agree to and tolerate repeated bronchial endoscopy (a disadvantage of all endoscopic treatments), - Male or female patients aged over 18 years, female patients should not be pregnant (menopause or contraception), - Patients should have given their written consent to take part in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Tracheal lesions and lesions affecting the carina tracheae, - Patients with painful bone metastases (not an absolute criterion since the extent of dyspnea is the decisive element). - Patients with brain metastases - Patients having undergone pneumonectomy, - Patients undergoing chemotherapy or radiotherapy or having undergone chemotherapy less than 4 weeks before the procedure or radiotherapy less than 3 weeks before the procedure. - Patients with risk of large vessel erosion or perforation resulting from lesion topography. - In case of allergy to the photosensitizer, - Leukopenia (WBC 1.5 normal Fibrinogen 1.5 ULN (Upper Limit of Normal) - Renal insufficiency - Hepatic insufficiency - Patients having already received 70 Gy on the lesion. - Existing tracheoesophageal or bronchoesophageal fistula - Emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the dose of WST11 and light energy necessary to obtain desobstruction of the bronchial lumen using vascular targeted photodynamic therapy (VTP) in obstructive non-small cell lung cancer.;Secondary Objective: - To demonstrate safety and quality of life in the follow-up of treatment in patients receiving WST11 and to assess the pharmacokinetic parameters and, possibly, the relationship between light/drug doses and treatment effects. - To study the safety, feasibility and efficacy of photodynamic therapy by WST11 in patients with completely or partially obstructing endobronchial non-small cell lung cancer. ;Primary end point(s): The primary endpoints mainly correspond to achieving significant removal of obstruction in patients with obstructive tumor lesions responsible for functional signs, in this purely palliative context. The initial assessment makes it possible to evaluate the percentage of obstruction; the endoscopic lesion must be responsible for the symptoms. The percentage of obstruction before and after treatment represents the main evaluation parameter. The functional signs resulting from removal of the obstruction will also be assessed before and after. | — |
Countries
France
Outcome results
None listed