| Titre |
A Phase III, Multicenter, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II -IIIA and IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer |
| Protocole ID |
CANOPY-A |
| ClinicalTrials.gov ID |
NCT03447769 |
| Type(s) de cancer |
Poumon non à petites cellules |
| Phase |
Phase III |
| Type étude |
Traitement |
| Médicament |
Canakinumab |
| Institution |
INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE DE QUEBEC - UL
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dre Catherine Labbé
|
| Coordonnateur(trice) |
Brigitte Fortin
418-656-8711 poste 2639
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Have completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease only) OR have NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and are candidates for complete resection surgery
- Must have recovered from all toxicities related to prior systemic therapy to grade ≤ 1 (CTCAE v 4.03). Exception to this criterion: subjects with any grade of alopecia and grade 2 or less neuropathy are allowed to enter the study
- Have ECOG performance status (PS) of 0 or 1
|
| Critètes d'exclusion |
- Have unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery
- Have received neoadjuvant chemotherapy or neoadjuvant radiotherapy
- Presence or history of a malignant disease, other than the resected NSCLC, that has been diagnosed and/or required therapy within the past 3 years Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, completely resected carcinoma in situ of any type and hormonal maintenance for breast and prostate cancer > 3 years.
- Have a history of current diagnosis of cardiac disease
- Have uncontrolled diabetes
- Have known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results)
- Subjects must be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis are not eligible.
- Have suspected or proven immunocompromised state as described in the protocol
- Had Live and attenuated vaccination within 3 months prior to first dose of study drug (e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).
|
Groupe d'étude en oncologie du Québec