| TITRE |
(EN) 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 |
| CLINICAL TRIAL.gov ID |
NCT05048797 |
| TYPE(S) DE CANCER |
Poumon non à petites cellules |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Scott Owen
|
| COORDONATEUR(RICE) |
Nicola Raby
nicola.raby@muhc.mcgill.ca
514-934-1934 poste 34095
|
| STATUT |
Actif en recrutement
|
| DATE D'ACTIVATION |
2022-10-21 |
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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
|
