E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obstructive endobronchial non-small cell lung cancer |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029514 |
E.1.2 | Term | Non-small cell lung cancer NOS |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
- 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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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<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
|
|
E.5 End points |
E.5.1 | 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.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 15 |