| Titre |
A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations |
| Protocole ID |
STAR-121 |
| ClinicalTrials.gov ID |
NCT05502237 |
| Type(s) de cancer |
Poumon non à petites cellules |
| Phase |
Phase III |
| Stade |
Métastatique |
| Type étude |
Clinique |
| Médicament |
Zimberelimab et domvanalimab en association avec de la chimiothérapie versus pembrolizumab en association avec de la chimiothérapie |
| Institution |
CISSS DES LAURENTIDES
 HOPITAL DE SAINT-JEROME
290 Rue de Montigny, Saint-Jérôme, QC, J7Z 5T3
|
| Ville |
Saint-Jérôme |
| Investigateur(trice) principal(e) |
Dr Ghislain Cournoyer
|
| Coordonnateur(trice) |
Yanick Sardin Laframboise
450-431-1020 poste 23429
|
| Statut |
 Actif en recrutement |
| Date d'activation |
25-07-2023 |
| Critètes d'éligibilité |
- Life expectancy ≥ 3 months.
-
Pathologically documented NSCLC that meets both of the criteria below:
- Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition).
- Have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations.
- Have no actionable genomic alterations such as ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other driver oncogenes with approved frontline therapies.
- Have not received prior systemic treatment for metastatic NSCLC.
- Measurable disease per RECIST v1.1 criteria by investigator assessment.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
- Have adequate organ functions.
|
| Critètes d'exclusion |
- Have mixed small-cell lung cancer (SCLC) and NSCLC histology.
- Positive serum pregnancy test or individuals who are breastfeeding or have plans to breastfeed during the study period.
- Received prior treatment with any anti-PD-1, anti-PD-L1, or any other antibody targeting an immune checkpoint.
- Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
- Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
- Have an active autoimmune disease that required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- Are receiving chronic systemic steroids.
- Have significant third-space fluid retention.
- Have untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has had an allogenic tissue/solid organ transplant.
- Have received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
- Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
|
Groupe d'étude en oncologie du Québec