Groupe d'Etude en Oncologie du Quebec

Titre	An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations
Protocole ID	DESTINY-Lung04
ClinicalTrials.gov ID	NCT05048797
Type(s) de cancer	Poumon non à petites cellules
Phase	Phase III
Stade	Maladie avancée ou métastatique
Type étude	Clinique
Médicament	Trastuzumab Deruxtecan
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville	Montréal
Investigateur(trice) principal(e)	Dr Scott Owen
Coordonnateur(trice)	Nicola Raby 514-934-1934 poste 34095
Statut	Actif en recrutement
Date d'activation	21-10-2022
Critètes d'éligibilité	Participants at least 18 years of age Locally advanced not amenable to curative therapy, or metastatic disease Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease Left ventricular ejection fraction (LVEF) ≥ 50% Measurable disease assessed by Investigator based on RECIST 1.1 Protocol-defined adequate organ function including cardiac, renal, hepatic function ECOG 0-1 Having tumour tissue available for central testing
Critètes d'exclusion	Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy) Any clinically active brain metastases; previously treated brain metastases allowed Active autoimmune or inflammatory disorders Medical history of myocardial infarction within 6 months prior to randomization History of non-infectious pneumonitis/ILD, current or suspected ILD Lung-specific intercurrent clinical significant severe illness Contraindication to platinum-based doublet chemotherapy or pembrolizumab

Groupe d'étude en oncologie du Québec