Clinical trial · Interventional
Study Using WST11 in Patients With Obstructing Endobronchial Non-Small Cell Lung Cancer
Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer
NCT00974662CI-TRIAL-00017660terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early end of enrolment with regards to difficulty met to enrol patients.
Summary
Brief summary (as posted)
The aim of this study is to determine the dose of WST11 and light energy necessary to obtain desobstruction of the bronchial lumen using Vascular Targeted Photodynamic therapy in obstructive Non-Small Cell Lung Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WST11 | Drug | Padeliporfin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- WST11
- description
- Treatment with WST11-mediated VTP
- interventionNames
- Drug: WST11
Primary outcomes (1)
- measure
- The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter.
- timeFrame
- Week 1, Month 1
Secondary outcomes (3)
- measure
- The evaluation of safety will be based on adverse events reporting throughout the duration of the study, on the monitoring of vital signs and ECGs, on laboratory tests,clinical examination and chest X Ray.
- timeFrame
- Screening-Month 3
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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 4 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\<2000), Thrombocytopenia (\< 100 000), PT \> 1.5 normal, Fibrinogen \< 2g/l, a PTT \> 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
References
Publications (0)
Data not yet available
No reference posted for this study.