| TITRE |
(EN) A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ? 50%) and Without Actionable Genomic Alterations |
| PROTOCOLE ID |
TROPION-Lung10 |
| CLINICAL TRIAL.gov ID |
NCT06357533 |
| TYPE(S) DE CANCER |
Poumon non à petites cellules |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CIUSSS DE LA MAURICIE-ET-DU-CENTRE-DU-QUEBEC
858 Terrasse Turcotte
(819) 375-3111
|
| VILLE |
Trois-Rivières
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Jean-Sébastien Aucoin
|
| COORDONATEUR(RICE) |
Marie-Ève Caron
marie-eve_caron_chrtr@ssss.gouv.qc.ca
819-697-3333 poste 63238
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Histologically or cytologically documented non-squamous NSCLC.
- Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
- Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved targeted first-line therapies.
- Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
- Known tumour PD-L1 expression status defined as TC ≥ 50%
- At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline
- ECOG performance status of 0 or 1
- Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention
|
| CRITÈRES D'EXCLUSION |
(EN)
- Prior systemic therapy for advanced/metastatic NSCLC.
- Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
- History of another primary malignancy within 3 years
- Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
- Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
- History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses
- Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
- History of leptomeningeal carcinomatosis
- Known clinically significant corneal disease
- Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
- History of active primary immunodeficiency
|
