| Titre |
A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% |
| Protocole ID |
MK-2870-007 |
| ClinicalTrials.gov ID |
NCT06170788 |
| Type(s) de cancer |
Poumon non à petites cellules |
| Phase |
Phase III |
| Type étude |
Clinique |
| Médicament |
Sacituzumab tirumotecan avec pembrolizumab versus pembrolizumab en monothérapie |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Jonathan Spicer
|
| Coordonnateur(trice) |
Nicola Raby
514-934-1934 poste 34095
|
| Statut |
 Actif en recrutement |
| Date d'activation |
23-07-2024 |
| Critètes d'éligibilité |
-
Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC
- Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
- Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
- A life expectancy of at least 3 months.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
|
| Critètes d'exclusion |
- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
- Has Grade ≥2 peripheral neuropathy.
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
- Received prior systemic anticancer therapy for their metastatic NSCLC.
- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
- Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
- Active infection requiring systemic therapy
- Concurrent active Hepatitis B and Hepatitis C virus infection.
- Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- History of allogeneic tissue/solid organ transplant.
- Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.
|
Groupe d'étude en oncologie du Québec